Completed

ExparelPain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane

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What is being tested

Exparel

+ IV Lidocaine

Drug
Who is being recruted

From 18 to 75 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2018
See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 22, 2018

Actual date on which the first participant was enrolled.

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.

Official TitlePain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
NCT04005859
Principal SponsorWake Forest University Health Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Age 18-75 years
Elective laparoscopic colorectal surgery
ASA I-III
10 exclusion criteria prevent from participating
Contraindication to Na Channel Blocker
Chronic Opioid use
Liver dysfunction
Renal insufficiency
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)

Group II

Active Comparator
CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Atrium Health - Carolinas Medical Center

Charlotte, United StatesOpen Atrium Health - Carolinas Medical Center in Google Maps
CompletedOne Study Center