CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 514 enrolled
Drug / intervention
EXPAREL +3 moredrug
Likely dose
Exparel (liposomal bupivacaine) 20 mL total (10 mL per side mixed with 10 mL saline); or Bupivacaine epidural infusionAI-extracted
Key inclusion· 6
  • Age 18–85 years
  • ASA Physical Status 1–3
  • Scheduled for elective open or laparoscopic abdominal surgery (colorectal, hysterectomy)
  • Anticipated hospitalization of at least 3 nights
Key exclusion· 6
  • Hepatic disease (liver enzymes >2× normal)
  • Renal disease (serum creatinine >2× normal)
  • Bupivacaine sensitivity or known allergy
  • Pregnant or breastfeeding women

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

Search/NCT02996227
NCT02996227N/ACompleted

Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial

The Cleveland Clinic·interventional·Posted Dec 19, 2016·Updated Jan 31, 2024

In Brief

A clinical study evaluating TAP block, Epidural analgesia, and 2 other interventions for Pain, Postoperative and Major Abdominal Surgery. Completed, enrolled 514 participants across 2 sites.

Detailed Summary

Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

Study Details

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

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 19, 2016
Enrollment StartDec 1, 2016
Primary CompletionJun 1, 2019
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.5 years ago

Interventions

TAP blockprocedure

Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.

Epidural analgesiaprocedure

Epidural catheters will be inserted preoperatively.

EXPARELdrug

Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.

Bupivacainedrug

Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.