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出境医 / 临床实验 / Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy

Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy

Study Description
Brief Summary:

The aim of the present study was to compare the effectiveness of transmuscular Quadratus Lumborum block using Bupivacaine versus Bupivacaine- Dexamethasone in providing analgesia in patients undergoing laparoscopic cholecystectomy.

Because postoperative pain after laparoscopic surgery is complex, specialists suggest that effective analgesic treatment should be a multimodal support. Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen. Dexamethasone, through its anti-inflammatory and blocking effects on neural discharge, and nociceptor C fibers transmission could be used as a local anesthetic adjuvant.


Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: TQL block with saline Drug: TQL block with Bupivacaine Drug: TQL block with Bupivacaine and dexamethasone Not Applicable

Detailed Description:

The patients were randomly allocated into three groups each contains (30) patient. Control group (C) received bilateral ultrasound guided quadratus lumborum block using (20 ml 0.9% normal saline + 1mL 0.9% normal saline) in each side ,Bupivacaine group (B) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1mL 0.9% normal saline) in each side and Dexamethasone-Bupivacaine group (D) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1 mL dexamethasone "4mg") in each side.

The following variables: heart Rate, mean arterial Blood Pressure, peripheral oxygen saturation, visual analogue pain scale , time to first analgesic request, total Analgesic requirement in the first 24 hours, patient satisfaction and complications were Recorded and compared between groups.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double blind
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone for Postoperative Analgesia in Laparoscopic Cholecystectomy
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: saline
bilateral quadratus lumborum block using 0.9% normal saline
Drug: TQL block with saline

drug: saline 21 ml 0.9% normal saline administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.

Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours.

Drug: Ketorolac analgesia In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than3.

Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block, ultrasound-guided

Other Name: C Group

Active Comparator: Bupivacaine
bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%
Drug: TQL block with Bupivacaine

Drug: saline

1mL 0.9% normal saline administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.

Drug: Paracetamol 15 mg.kg will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given to all cases every 8 hours.

Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3.

Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block

Other Name: B Group

Active Comparator: Bupivacaine and dexamethasone
bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone
Drug: TQL block with Bupivacaine and dexamethasone

Drug: dexamethasone

1 mL dexamethasone "4mg" administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in MBP or HR of more than 20% of baseline for longer than 5 minutes.

Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours.

Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3.

Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block

Other Name: D Group

Outcome Measures
Primary Outcome Measures :
  1. Time for first request to rescue analgesia [ Time Frame: 24 hours ]
    Time for the first request to rescue analgesia (in minutes)


Secondary Outcome Measures :
  1. postoperative Nalbuphine [ Time Frame: 24 hours after surgery ]
    Cumulative postoperative Nalbuphine consumption (total dose given in milligrams)

  2. intraoperative fentanyl [ Time Frame: For 4 hours after start of anaesthesia ]
    Cumulative intraoperative fentanyl consumption (total dose given in micrograms)

  3. Postoperative pain severity will be assessed using VAPS [ Time Frame: For 24 hours after surgery ]
    The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAPS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain

  4. side effects [ Time Frame: For 24 hours after surgery ]
    Incidence of postoperative nausea and vomiting


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Physical Status I or II
  • Elective laparoscopic Cholecystectomy

Exclusion Criteria:

  • Patient refusal.
  • Hematological diseases
  • Bleeding disorders.
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection
  • Sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m2.
  • Emergency laparoscopic cholecystectomy
  • If laparoscopic procedure converted to open.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Haidy S Mansour, MD 01221802324 ext +2 haidy_mourad@yahoo.com
Contact: Mohmed S Abdelrahman, Dr 01000344985 ext +2 dr.ma55.ma@gmail.com

Locations
Layout table for location information
Egypt
Minya University Recruiting
Minya, Egypt, 61519
Contact: haidy S Mansour, MD    01221802324 ext +2    haidy_mourad@yahoo.com   
Contact: mohamed A abdelrahman, Dr    01000344985 ext +2    dr.ma55.ma@gmail.com   
Sponsors and Collaborators
Minia University
Investigators
Layout table for investigator information
Study Director: Haidy S Mansour, MD assistant professor of Anesthesia and Surgical Intensive Care
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date September 3, 2020
Actual Study Start Date  ICMJE November 20, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2019)
Time for first request to rescue analgesia [ Time Frame: 24 hours ]
Time for the first request to rescue analgesia (in minutes)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2019)
  • postoperative Nalbuphine [ Time Frame: 24 hours after surgery ]
    Cumulative postoperative Nalbuphine consumption (total dose given in milligrams)
  • intraoperative fentanyl [ Time Frame: For 4 hours after start of anaesthesia ]
    Cumulative intraoperative fentanyl consumption (total dose given in micrograms)
  • Postoperative pain severity will be assessed using VAPS [ Time Frame: For 24 hours after surgery ]
    The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAPS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
  • side effects [ Time Frame: For 24 hours after surgery ]
    Incidence of postoperative nausea and vomiting
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy
Official Title  ICMJE Ultrasound-guided Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone for Postoperative Analgesia in Laparoscopic Cholecystectomy
Brief Summary

The aim of the present study was to compare the effectiveness of transmuscular Quadratus Lumborum block using Bupivacaine versus Bupivacaine- Dexamethasone in providing analgesia in patients undergoing laparoscopic cholecystectomy.

Because postoperative pain after laparoscopic surgery is complex, specialists suggest that effective analgesic treatment should be a multimodal support. Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen. Dexamethasone, through its anti-inflammatory and blocking effects on neural discharge, and nociceptor C fibers transmission could be used as a local anesthetic adjuvant.

Detailed Description

The patients were randomly allocated into three groups each contains (30) patient. Control group (C) received bilateral ultrasound guided quadratus lumborum block using (20 ml 0.9% normal saline + 1mL 0.9% normal saline) in each side ,Bupivacaine group (B) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1mL 0.9% normal saline) in each side and Dexamethasone-Bupivacaine group (D) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1 mL dexamethasone "4mg") in each side.

The following variables: heart Rate, mean arterial Blood Pressure, peripheral oxygen saturation, visual analogue pain scale , time to first analgesic request, total Analgesic requirement in the first 24 hours, patient satisfaction and complications were Recorded and compared between groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, double blind
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post Operative Pain
Intervention  ICMJE
  • Drug: TQL block with saline

    drug: saline 21 ml 0.9% normal saline administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.

    Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours.

    Drug: Ketorolac analgesia In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than3.

    Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block, ultrasound-guided

    Other Name: C Group
  • Drug: TQL block with Bupivacaine

    Drug: saline

    1mL 0.9% normal saline administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.

    Drug: Paracetamol 15 mg.kg will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given to all cases every 8 hours.

    Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3.

    Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block

    Other Name: B Group
  • Drug: TQL block with Bupivacaine and dexamethasone

    Drug: dexamethasone

    1 mL dexamethasone "4mg" administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in MBP or HR of more than 20% of baseline for longer than 5 minutes.

    Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours.

    Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3.

    Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block

    Other Name: D Group
Study Arms  ICMJE
  • Placebo Comparator: saline
    bilateral quadratus lumborum block using 0.9% normal saline
    Intervention: Drug: TQL block with saline
  • Active Comparator: Bupivacaine
    bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%
    Intervention: Drug: TQL block with Bupivacaine
  • Active Comparator: Bupivacaine and dexamethasone
    bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone
    Intervention: Drug: TQL block with Bupivacaine and dexamethasone
Publications * Not Provided

*   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: May 18, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Physical Status I or II
  • Elective laparoscopic Cholecystectomy

Exclusion Criteria:

  • Patient refusal.
  • Hematological diseases
  • Bleeding disorders.
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection
  • Sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m2.
  • Emergency laparoscopic cholecystectomy
  • If laparoscopic procedure converted to open.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Haidy S Mansour, MD 01221802324 ext +2 haidy_mourad@yahoo.com
Contact: Mohmed S Abdelrahman, Dr 01000344985 ext +2 dr.ma55.ma@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956966
Other Study ID Numbers  ICMJE 88-11/2018
Has Data Monitoring Committee No
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 Not Provided
Responsible Party haidy salah mansour, Minia University
Study Sponsor  ICMJE Minia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Haidy S Mansour, MD assistant professor of Anesthesia and Surgical Intensive Care
PRS Account Minia University
Verification Date September 2020

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