Phase 3 N=90 Randomized Double-blind Treatment

Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery

Colorectal Surgery

Bottom Line

View on ClinicalTrials.gov: NCT03702621 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: VAS Score at 1 Hour at Rest — 5.0; 3.0 score on a scale — p=0.54

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: liposomal Bupivacaine (Drug); Bupivacaine Hydrochloride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY VAS Score at 1 Hour at Rest	5.0; 3.0	0.54
PRIMARY VAS Score at 1 Hour With Movement	5.0; 3.0	0.59
PRIMARY VAS Score at 24 Hours at Rest	4.0; 3.0	0.98
PRIMARY VAS Score at 24 Hours With Movement	7.0; 6.0	0.94
PRIMARY VAS Score at 48 Hours at Rest	3.0; 2.5	0.86
PRIMARY VAS Score at 48 Hours With Movement	5.0; 5.0	1.0
PRIMARY VAS Score at 72 Hours at Rest	2.0; 2.0	0.99
PRIMARY VAS Score at 72 Hours With Movement	4.0; 3.0	0.99
SECONDARY Total Opioid Consumption at 1 Hour	8.0; 2.0	0.72
SECONDARY Total Opioid Consumption at 24 Hour	54.0; 30.0	0.29
SECONDARY Total Opioid Consumption at 48 Hour	43.8; 15.0	0.46
SECONDARY Total Opioid Consumption at 72 Hour	17.5; 15.0	0.77

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

Eligibility Criteria

Inclusion criteria

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

Exclusion criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03702621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.