Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery

NCT03702621 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 1806187876
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (8)

• VAS Score at 1 Hour at Rest

  The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 1 hour after surgery

• VAS Score at 1 Hour With Movement

  The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 1 hour after surgery

• VAS Score at 24 Hours at Rest

  The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 24 hours after surgery

• VAS Score at 24 Hours With Movement

  The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 24 hours after surgery

• VAS Score at 48 Hours at Rest

  The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 48 hours after surgery

• VAS Score at 48 Hours With Movement

  The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 48 hours after surgery

• VAS Score at 72 Hours at Rest

  The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 72 hours after surgery

• VAS Score at 72 Hours With Movement

  The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 72 hours after surgery

Secondary Outcomes (4)

• Total Opioid Consumption at 1 Hour

  Opioid consumption will be measured at 1 hour post op. The total amount will be recorded

• Total Opioid Consumption at 24 Hour

  Opioid consumption will be measured at 24 hour post op. The total amount will be recorded

• Total Opioid Consumption at 48 Hour

  Opioid consumption will be measured at 48 hour post op. The total amount will be recorded

• Total Opioid Consumption at 72 Hour

  Opioid consumption will be measured at 72 hour post op. The total amount will be recorded

Other Outcomes (29)

• Nausea Scores (None) at 1 Hour

  Nausea scores will be measured at 1 hour post-op.

• Nausea Scores (Mild) at 1 Hour

  Nausea scores will be measured at 1 hour post-op.

• Nausea Scores (Moderate) at 1 Hour

  Nausea scores will be measured at 1 hour post-op.

Study Arms (2)

Liposomal Bupivacaine

ACTIVE COMPARATOR

LB (Liposomal Bupivacaine) group - This group will be receiving 20 mL EXPAREL (266mg) and 40 mL of 0.125% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.

Drug: liposomal Bupivacaine

Standard Bupivacaine

ACTIVE COMPARATOR

SB (Standard Bupivacaine) group - This group will be receiving 60 mL of 0.25% bupivacaine in total, 30 mL on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.

Drug: Bupivacaine Hydrochloride

Interventions

liposomal Bupivacaine DRUG

20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group

Liposomal Bupivacaine

Bupivacaine Hydrochloride DRUG

40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group. 60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group

Standard Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing colorectal surgery at Indiana University Hospital
• American Society of Anesthesiologists (ASA) class 1, 2, 3 or 4
• Age 18 or older, male or female
• Desires Regional anesthesia for postoperative pain control

You may not qualify if:

• Any contraindication for QL block.
• History of substance abuse in the past 6 months.
• Patients on more than 30mg morphine equivalents of opioids daily.
• Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
• Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).
• Postoperative intubation.
• Any BMI greater than 40.0.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Yeap YL, Wolfe J, Stewart J, McCutchan A, Chawla G, Robb B, Holcomb B, Vickery B. Liposomal bupivacaine addition versus standard bupivacaine alone for colorectal surgery: a randomized controlled trial. Pain Manag. 2022 Jan;12(1):35-43. doi: 10.2217/pmt-2021-0033. Epub 2021 Sep 23.

  PMID: 34551581 DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Yar Luan Yeap
• Organization: Indiana University

yyeap@iupui.edu

317-274-0275

Study Officials

• Yar Yeap, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the patients and the research staff doing assessments will be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Acute Pain Service Assistant Professor of Clinical Anesthesiology Indiana University School of Medicine Department of Anesthesiology

Model Details: 1. LB group (Liposomal Bupivacaine) 2. SB group (Standard Bupivacaine)

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: October 11, 2018
• Study Start: August 30, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-05

Locations

US (1)