CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Exparel +1 moredrug
Likely dose
Exparel 20 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04005859
NCT04005859Phase 4Completed

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

Wake Forest University Health Sciences·interventional·Posted Jul 2, 2019·Updated Aug 9, 2022

In Brief

A Phase 4 clinical trial evaluating Exparel and IV Lidocaine for Colorectal Disorders. Completed, enrolled 61 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2019
Enrollment StartFeb 22, 2018
Primary CompletionMay 9, 2019
Study CompletionJul 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7 years ago

Interventions

Expareldrug

2\. Liposomal bupivacaine TAP block (experimental arm) 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.

IV Lidocainedrug

1\. Intravenous Lidocaine infusion (control arm, current standard of care) 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.