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出境医 / 临床实验 / Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial

Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial

Study Description
Brief Summary:

Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pain. it is shown that it increases health costs related to longer recovery times, longer hospital stay and related complications such as the increased risk of presenting chronic POP pain, which it has been estimated up to 20%, much higher if the surgery involves surgery in the gastrointestinal system.

The goal of analgesia in the postoperative setting is precisely to provide comfort to patients, minimize adverse effects and complications arising from the procedure.

The epidural analgesic technique (has been proposed as an analgesic management standard, since multiple studies have shown that it reduces opioid consumption, improves recovery and is a useful strategy for pain control. However, it is an invasive technique, with risk of complications such as hematomas and epidural abscesses, and it may be difficult to perform.

Currently it has been shown in multiple studies that the intravenous infusion of a local anesthetic, such as lidocaine, in this type of surgical scenarios can reduce the intensity of pain, opioid consumption, hospital stay and ileus with few adverse effects. In addition, these studies propose that, being a less invasive technique, it could be easier to implement and even be safer than the epidural technique.

The main hypothesis of this study is precisely that the infusion of lidocaine may be non-inferior to epidural analgesia in the analgesic management of patients undergoing major abdominal surgery.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Opioid Use Procedure: Epidural Analgesia Drug: Lidocaine Infusion Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All patients who accept participation in the study and meet all inclusion criteria will be randomly assigned at the time of anesthetic induction. The assignment to the group of epidural analgesia vs IV lidocaine will be 1: 1 randomly using permuted blocks generated by a computer operated by an external assistant to the investigation. The size of the blocks will be variable between 4, 6, and 8, and will be kept confidential to guarantee the concealment of the groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

The masking process will be done as follows:

Masking of the data collection and analysis staff: The investigative staff who performs the data collection and who evaluates the outcomes after the anesthetic act, will not have information about the intervention received by the patient. Those who participate in the data analysis phase will also be blind to the intervention.

For practical and ethical point of view, it is not possible to mask the doctors who perform the intervention and neither the patients. A "SHAM" or simulated intervention is not possible given that this would require an unnecessary invasive procedure that would not be used, which would make it ethically questionable.
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Epidural Analgesia

The placement of the thoracic epidural catheter will be located depending on surgical incision as follows:

  • Surgery of the upper abdomen: T7-T8.
  • Surgery of lower abdomen: T8-T9. The epidural catheter placement technique will be determined by the treating anesthesiologist. However, once the epidural space is located and the respective catheter is inserted, the correct location of the catheter should be tested with lidocaine at 2% CE 5 cc and a sensitivity test with temperature should be performed on the target dermatomes. A negative test for an adequate location of the catheter indicates that the procedure should be repeated until the epidural space is correctly located. Once this is achieved, the catheter will be left 4 cm away from the skin. The catheter will be fixed according to the institutional protocol.
 Procedure: Epidural Analgesia

The epidural infusion will be as follows:

  • Isobaric Bupivacaine 0.5% 40 cc
  • Morphine 4 mg (1 ampoule up to 10 cc and 4 cc of the mixture will be applied)
  • Saline solution 0.9% 156 cc.
  • Total Volume: 200 cc.

This mixture will be prepared by a nurse outside the research group outside the operating room once indicated.

The infusion will be scheduled at 7 cc / hour per continuous infusion set and will be connected to the epidural catheter after its placement.
Experimental: Lidocaine Infussion
Intravenous lidocaine
 Drug: Lidocaine Infusion
2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.
Outcome Measures
Primary Outcome Measures :
  1. Posoperative Pain [ Time Frame: 24 hours after surgery ]
    Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").


Secondary Outcome Measures :
  1. Posoperative Pain [ Time Frame: 2, 6, 12, 48 and 72 hours after surgery ]
    Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").

  2. Posoperative opioid use [ Time Frame: 24 hours after surgery ]
    mg of morphine

  3. Hospital Stay [ Time Frame: From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 100 months ]
    days

  4. Perioperative Satisfaction [ Time Frame: 24 hours ]
    Evaluation du Vecu de l'Anesthesie Generale (EVAN G scale). The EVAN questionnaire is composed of 6 dimensions (attention, privacy, information, pain, discomfort and waiting times), which in turn consist of 26 items. Each item is evaluated with in an ordinal scale. The minimum value is 1, meaning the worst value for the item and the maximum value is 5, meaning the better value for the item.

  5. Toxicity by local anesthetics proportion [ Time Frame: 24 hours after surgery ]

    Proportion of patients presenting signs of toxicity by local anesthetics.

    • Metal taste
    • Tinnitus
    • Hypotension (SBP less than 80 mmHg)
    • Tachycardia (FC greater than 130)
    • Bradycardia (FC less than 40)
    • Alterations of the mental state. It is positive for this outcome with 3 signs or if patient presents seizures or coma without a non-surgical or medical cause associated with the patient's clinical status.

  6. Posoperative nausea and vomiting [ Time Frame: 24 hours after surgey ]
    Proportion of patients with at least one episode of nausea or vomiting in the postoperative period.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient over 18 years.

  • Elective major open intra-abdominal surgery:

    • Cholecystectomy.
    • Total or subtotal gastrectomy.
    • Colectomy or Hemicolectomy.
    • Pancreatoduodenectomy.
    • Hepatectomy 1 or 2 segments.
    • Exploration and / or reconstruction of the bile duct.
    • Abdominal demolition.
    • Sigmoidectomy.
  • Patient classified as ASA (American Association of Anesthesiology) 1, 2 or 3.

Exclusion Criteria:

  • Pregnant woman

  • Patient with contraindication for epidural analgesic techniques:

    1. Anticoagulated patient
    2. Active infection in the puncture site.
    3. Malformation in spinal cord.
    4. Sepsis without antibiotic treatment.
    5. Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
    6. Patient with known allergy to opioids and / or local anesthetics.
    7. Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
    8. Patient with liver failure or terminal renal failure.
    9. Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
    10. Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
    11. Patient who was technically impossible to place an epidural catheter in surgery.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Fabian Casas, Dr 0544441333 ext 2510 fabian.casas@udea.edu.co
Contact: Mario Zamudio, Dr 0544441333 ext 2510 mario.zamudio@udea.edu.co

Locations
Layout table for location information
Colombia
Antioquias Univervesity Health Institution Recruiting
Medellin, Antioquia, Colombia
Contact: Fabian Casas, MD    054 4441333 ext 2510    fabian.casas@udea.edu.co   
Contact: Susana Osorno, MD    4441333 ext 2510    susana.osorno@udea.edu.co   
Sponsors and Collaborators
Universidad de Antioquia
IPS Universitaria-Universidad de Antioquia
Investigators
Layout table for investigator information
Principal Investigator: Fabian Casas, Dr Univeridad de Antioquia's Professor
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		Posoperative Pain [ Time Frame: 24 hours after surgery ]
Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • Posoperative Pain [ Time Frame: 2, 6, 12, 48 and 72 hours after surgery ]
    Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
  • Posoperative opioid use [ Time Frame: 24 hours after surgery ]
    mg of morphine
  • Hospital Stay [ Time Frame: From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 100 months ]
    days
  • Perioperative Satisfaction [ Time Frame: 24 hours ]
    Evaluation du Vecu de l'Anesthesie Generale (EVAN G scale). The EVAN questionnaire is composed of 6 dimensions (attention, privacy, information, pain, discomfort and waiting times), which in turn consist of 26 items. Each item is evaluated with in an ordinal scale. The minimum value is 1, meaning the worst value for the item and the maximum value is 5, meaning the better value for the item.
  • Toxicity by local anesthetics proportion [ Time Frame: 24 hours after surgery ]
    Proportion of patients presenting signs of toxicity by local anesthetics.
    • Metal taste
    • Tinnitus
    • Hypotension (SBP less than 80 mmHg)
    • Tachycardia (FC greater than 130)
    • Bradycardia (FC less than 40)
    • Alterations of the mental state. It is positive for this outcome with 3 signs or if patient presents seizures or coma without a non-surgical or medical cause associated with the patient's clinical status.
  • Posoperative nausea and vomiting [ Time Frame: 24 hours after surgey ]
    Proportion of patients with at least one episode of nausea or vomiting in the postoperative period.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Posoperative Pain [ Time Frame: 2, 6, 12, 48 and 72 hours after surgery ]
    Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
  • Posoperative opioid use [ Time Frame: 24 hours after surgery ]
    mg of morphine
  • Hospital Stay [ Time Frame: From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 100 months ]
    days
  • Quality of recovery [ Time Frame: 24 hours ]
    Quality of Recovery Scale (QoR-40 scale). It is a 40-item questionnaire. The QoR-40 is a global measure of quality of recovery. It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
  • Toxicity by local anesthetics proportion [ Time Frame: 24 hours after surgery ]
    Proportion of patients presenting signs of toxicity by local anesthetics.
    • Metal taste
    • Tinnitus
    • Hypotension (SBP less than 80 mmHg)
    • Tachycardia (FC greater than 130)
    • Bradycardia (FC less than 40)
    • Alterations of the mental state. It is positive for this outcome with 3 signs or if patient presents seizures or coma without a non-surgical or medical cause associated with the patient's clinical status.
  • Posoperative nausea and vomiting [ Time Frame: 24 hours after surgey ]
    Proportion of patients with at least one episode of nausea or vomiting in the postoperative period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
Official Title  ICMJE Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
Brief Summary

Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pain. it is shown that it increases health costs related to longer recovery times, longer hospital stay and related complications such as the increased risk of presenting chronic POP pain, which it has been estimated up to 20%, much higher if the surgery involves surgery in the gastrointestinal system.

The goal of analgesia in the postoperative setting is precisely to provide comfort to patients, minimize adverse effects and complications arising from the procedure.

The epidural analgesic technique (has been proposed as an analgesic management standard, since multiple studies have shown that it reduces opioid consumption, improves recovery and is a useful strategy for pain control. However, it is an invasive technique, with risk of complications such as hematomas and epidural abscesses, and it may be difficult to perform.

Currently it has been shown in multiple studies that the intravenous infusion of a local anesthetic, such as lidocaine, in this type of surgical scenarios can reduce the intensity of pain, opioid consumption, hospital stay and ileus with few adverse effects. In addition, these studies propose that, being a less invasive technique, it could be easier to implement and even be safer than the epidural technique.

The main hypothesis of this study is precisely that the infusion of lidocaine may be non-inferior to epidural analgesia in the analgesic management of patients undergoing major abdominal surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All patients who accept participation in the study and meet all inclusion criteria will be randomly assigned at the time of anesthetic induction. The assignment to the group of epidural analgesia vs IV lidocaine will be 1: 1 randomly using permuted blocks generated by a computer operated by an external assistant to the investigation. The size of the blocks will be variable between 4, 6, and 8, and will be kept confidential to guarantee the concealment of the groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

The masking process will be done as follows:

Masking of the data collection and analysis staff: The investigative staff who performs the data collection and who evaluates the outcomes after the anesthetic act, will not have information about the intervention received by the patient. Those who participate in the data analysis phase will also be blind to the intervention.

For practical and ethical point of view, it is not possible to mask the doctors who perform the intervention and neither the patients. A "SHAM" or simulated intervention is not possible given that this would require an unnecessary invasive procedure that would not be used, which would make it ethically questionable.

Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Opioid Use
Intervention  ICMJE
  • Procedure: Epidural Analgesia

    The epidural infusion will be as follows:

    • Isobaric Bupivacaine 0.5% 40 cc
    • Morphine 4 mg (1 ampoule up to 10 cc and 4 cc of the mixture will be applied)
    • Saline solution 0.9% 156 cc.
    • Total Volume: 200 cc.

    This mixture will be prepared by a nurse outside the research group outside the operating room once indicated.

    The infusion will be scheduled at 7 cc / hour per continuous infusion set and will be connected to the epidural catheter after its placement.

  • Drug: Lidocaine Infusion
    2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.
Study Arms  ICMJE
  • Active Comparator: Epidural Analgesia

    The placement of the thoracic epidural catheter will be located depending on surgical incision as follows:

    • Surgery of the upper abdomen: T7-T8.
    • Surgery of lower abdomen: T8-T9. The epidural catheter placement technique will be determined by the treating anesthesiologist. However, once the epidural space is located and the respective catheter is inserted, the correct location of the catheter should be tested with lidocaine at 2% CE 5 cc and a sensitivity test with temperature should be performed on the target dermatomes. A negative test for an adequate location of the catheter indicates that the procedure should be repeated until the epidural space is correctly located. Once this is achieved, the catheter will be left 4 cm away from the skin. The catheter will be fixed according to the institutional protocol.
    Intervention: Procedure: Epidural Analgesia
  • Experimental: Lidocaine Infussion
    Intravenous lidocaine
    Intervention: Drug: Lidocaine Infusion
Publications *
  • Shipton EA. The transition from acute to chronic post surgical pain. Anaesth Intensive Care. 2011 Sep;39(5):824-36. Review.
  • Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2. Review. Update in: Cochrane Database Syst Rev. 2018 Jun 04;6:CD009642.
  • Couceiro TC, Valença MM, Lima LC, de Menezes TC, Raposo MC. Prevalence and influence of gender, age, and type of surgery on postoperative pain. Rev Bras Anestesiol. 2009 May-Jun;59(3):314-20. English, Portuguese.
  • Singh PK, Saikia P, Lahakar M. Prevalence of acute post-operative pain in patients in adult age-group undergoing inpatient abdominal surgery and correlation of intensity of pain and satisfaction with analgesic management: A cross-sectional single institute-based study. Indian J Anaesth. 2016 Oct;60(10):737-743.
  • Bouman EA, Theunissen M, Bons SA, van Mook WN, Gramke HF, van Kleef M, Marcus MA. Reduced incidence of chronic postsurgical pain after epidural analgesia for abdominal surgery. Pain Pract. 2014 Feb;14(2):E76-84. doi: 10.1111/papr.12091. Epub 2013 Jun 12.
  • Li M, Li L, Xu Y, Wang X. Intravenous analgesics for pain management in post- operative patients : a comparative study of their efficacy and adverse effects. 2016;15(August):1799-806.
  • Singh AP, Singh D, Singh Y, Jain G. Postoperative analgesic efficacy of epidural tramadol as adjutant to ropivacaine in adult upper abdominal surgeries. Anesth Essays Res. 2015 Sep-Dec;9(3):369-73. doi: 10.4103/0259-1162.161805.
  • Nworah U. From documentation to the problem: controlling postoperative pain. Nurs Forum. 2012 Apr-Jun;47(2):91-9. doi: 10.1111/j.1744-6198.2012.00262.x.
  • Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8. Erratum in: Dis Colon Rectum. 2013 Feb;52(2):271.
  • Ventham NT, Kennedy ED, Brady RR, Paterson HM, Speake D, Foo I, Fearon KC. Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. World J Surg. 2015 Sep;39(9):2220-34. doi: 10.1007/s00268-015-3105-6. Review.
  • Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal local anaesthetic in abdominal surgery - a systematic review. ANZ J Surg. 2011 Apr;81(4):237-45. doi: 10.1111/j.1445-2197.2010.05573.x. Epub 2010 Nov 17. Review.
  • Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014. Review.
  • Ventham NT, Hughes M, O'Neill S, Johns N, Brady RR, Wigmore SJ. Systematic review and meta-analysis of continuous local anaesthetic wound infiltration versus epidural analgesia for postoperative pain following abdominal surgery. Br J Surg. 2013 Sep;100(10):1280-9. Review.
  • Nimmo SM, Harrington LS. What is the role of epidural analgesia in abdominal surgery? Contin Educ Anaesthesia, Crit Care Pain. 2014;14(5):224-9.
  • Nichimori M, Low J, JC B. Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery (Cochrane Reviews). Cochrane Libr [Internet]. 2006;103(6):1577.
  • Peters ML, Sommer M, de Rijke JM, Kessels F, Heineman E, Patijn J, Marcus MA, Vlaeyen JW, van Kleef M. Somatic and psychologic predictors of long-term unfavorable outcome after surgical intervention. Ann Surg. 2007 Mar;245(3):487-94.
  • Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. Review.
  • Jørgensen H, Wetterslev J, Møiniche S, Dahl JB. Epidural local anaesthetics versus opioid-based analgesic regimens on postoperative gastrointestinal paralysis, PONV and pain after abdominal surgery. Cochrane Database Syst Rev. 2000;(4):CD001893. Review. Update in: Cochrane Database Syst Rev. 2016;7:CD001893.
  • Pöpping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.
  • Terkawi AS, Tsang S, Kazemi A, Morton S, Luo R, Sanders DT, Regali LA, Columbano H, Kurtzeborn NY, Durieux ME. A Clinical Comparison of Intravenous and Epidural Local Anesthetic for Major Abdominal Surgery. Reg Anesth Pain Med. 2016 Jan-Feb;41(1):28-36. doi: 10.1097/AAP.0000000000000332.
  • Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-5, table of contents.
  • Wongyingsinn M, Baldini G, Charlebois P, Liberman S, Stein B, Carli F. Intravenous lidocaine versus thoracic epidural analgesia: a randomized controlled trial in patients undergoing laparoscopic colorectal surgery using an enhanced recovery program. Reg Anesth Pain Med. 2011 May-Jun;36(3):241-8. doi: 10.1097/AAP.0b013e31820d4362.
  • Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.
  • Staikou C, Avramidou A, Ayiomamitis GD, Vrakas S, Argyra E. Effects of intravenous versus epidural lidocaine infusion on pain intensity and bowel function after major large bowel surgery: a double-blind randomized controlled trial. J Gastrointest Surg. 2014 Dec;18(12):2155-62. doi: 10.1007/s11605-014-2659-1. Epub 2014 Sep 23.
  • Khan JS, Yousuf M, Victor JC, Sharma A, Siddiqui N. An estimation for an appropriate end time for an intraoperative intravenous lidocaine infusion in bowel surgery: a comparative meta-analysis. J Clin Anesth. 2016 Feb;28:95-104. doi: 10.1016/j.jclinane.2015.07.007. Epub 2015 Sep 3. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		206
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient over 18 years.

  • Elective major open intra-abdominal surgery:

    • Cholecystectomy.
    • Total or subtotal gastrectomy.
    • Colectomy or Hemicolectomy.
    • Pancreatoduodenectomy.
    • Hepatectomy 1 or 2 segments.
    • Exploration and / or reconstruction of the bile duct.
    • Abdominal demolition.
    • Sigmoidectomy.
  • Patient classified as ASA (American Association of Anesthesiology) 1, 2 or 3.

Exclusion Criteria:

  • Pregnant woman

  • Patient with contraindication for epidural analgesic techniques:

    1. Anticoagulated patient
    2. Active infection in the puncture site.
    3. Malformation in spinal cord.
    4. Sepsis without antibiotic treatment.
    5. Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
    6. Patient with known allergy to opioids and / or local anesthetics.
    7. Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
    8. Patient with liver failure or terminal renal failure.
    9. Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
    10. Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
    11. Patient who was technically impossible to place an epidural catheter in surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Fabian Casas, Dr 0544441333 ext 2510 fabian.casas@udea.edu.co
Contact: Mario Zamudio, Dr 0544441333 ext 2510 mario.zamudio@udea.edu.co
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04017013
Other Study ID Numbers  ICMJE SIIU 2001-15550
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universidad de Antioquia
Study Sponsor  ICMJE Universidad de Antioquia
Collaborators  ICMJE IPS Universitaria-Universidad de Antioquia
Investigators  ICMJE
Principal Investigator: Fabian Casas, Dr Univeridad de Antioquia's Professor
PRS Account Universidad de Antioquia
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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