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出境医 / 临床实验 / Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane (Exparel)

Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane (Exparel)

Study Description
Brief Summary:
To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.

Condition or disease Intervention/treatment Phase
Colorectal Disorders Drug: Exparel Drug: IV Lidocaine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : February 22, 2020
Estimated Study Completion Date : February 22, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: CONTROL: IV Lido
CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)
 Drug: IV Lidocaine

1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35

  1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
  2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
  3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
Experimental: EXPERIMENTAL: Exparel
EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)
 Drug: Exparel

2. Liposomal bupivacaine TAP block (experimental arm) n= 35

  1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
  2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
  3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
  4. Adhesive tapes will be applied at the level of the TAP block puncture sites.
Outcome Measures
Primary Outcome Measures :
  1. Change in Verbal Pain Scale (VRS) [ Time Frame: every 6 hours postoperatively for the first 24 hours, then at least every 6 hours as per standard nursing protocol with vital signs and administration of pain medications. Additionally at 2 and 4 weeks from discharge. ]
    postoperative pain as measured by verbal rate scale (VRS) Scale of 0-10. The scale measures pain amount on a scale of 1-10 under the following scenarios: pain right now, pain at rest, and pain while active. The scale ranges from 1 'no pain' to 10 'worst possible, unbearable, excruciating pain.' The scale is measured by taking the individual scores of the three conditions mentioned. Then, we look at how each of those three conditions change over time. Subscales are scored separately and we do not average scores.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-75 years
  • Elective laparoscopic colorectal surgery
  • ASA I-III

Exclusion Criteria:

  • Contraindication to Na Channel Blocker
  • Chronic Opioid use
  • Liver dysfunction
  • Renal insufficiency
  • Epilepsy
  • Psychomotor retardation
  • BMI >40
  • Sleep Apnea
  • Cardiac Rhythm Disorders
  • Planned open or concomitant procedure
Contacts and Locations

Locations
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United States, North Carolina
Carolinas Medical Center - Atrium Health
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE February 22, 2018
Estimated Primary Completion Date February 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		Change in Verbal Pain Scale (VRS) [ Time Frame: every 6 hours postoperatively for the first 24 hours, then at least every 6 hours as per standard nursing protocol with vital signs and administration of pain medications. Additionally at 2 and 4 weeks from discharge. ]
postoperative pain as measured by verbal rate scale (VRS) Scale of 0-10. The scale measures pain amount on a scale of 1-10 under the following scenarios: pain right now, pain at rest, and pain while active. The scale ranges from 1 'no pain' to 10 'worst possible, unbearable, excruciating pain.' The scale is measured by taking the individual scores of the three conditions mentioned. Then, we look at how each of those three conditions change over time. Subscales are scored separately and we do not average scores.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Official Title  ICMJE Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Brief Summary To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Disorders
Intervention  ICMJE
  • Drug: Exparel

    2. Liposomal bupivacaine TAP block (experimental arm) n= 35

    1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
    2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
    3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
    4. Adhesive tapes will be applied at the level of the TAP block puncture sites.
  • Drug: IV Lidocaine

    1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35

    1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
    2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
    3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
Study Arms  ICMJE
  • Active Comparator: CONTROL: IV Lido
    CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)
    Intervention: Drug: IV Lidocaine
  • Experimental: EXPERIMENTAL: Exparel
    EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)
    Intervention: Drug: Exparel
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 22, 2020
Estimated Primary Completion Date February 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-75 years
  • Elective laparoscopic colorectal surgery
  • ASA I-III

Exclusion Criteria:

  • Contraindication to Na Channel Blocker
  • Chronic Opioid use
  • Liver dysfunction
  • Renal insufficiency
  • Epilepsy
  • Psychomotor retardation
  • BMI >40
  • Sleep Apnea
  • Cardiac Rhythm Disorders
  • Planned open or concomitant procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005859
Other Study ID Numbers  ICMJE 01-18-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kevin Kasten, Atrium Health
Study Sponsor  ICMJE Atrium Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Atrium Health
Verification Date July 2019

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

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