CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 102 enrolled
Drug / intervention
Liposomal bupivacaine +1 moredrug
Likely dose
Not stated in 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/NCT03723447
NCT03723447Phase 4Completed
CompareCT.gov

A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial

Cedars-Sinai Medical Center·interventional·Posted Oct 29, 2018·Updated Feb 17, 2021

In Brief

A Phase 4 clinical trial evaluating Liposomal bupivacaine and Bupivacaine/epinephrine/dexamethasone for Pain, Postoperative and 9 related conditions. Completed, enrolled 102 participants across 1 site.

Detailed Summary

Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity as a long-lasting TAP block medication, but has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which may offer similar effects. We conduct a prospective randomized prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative, Crohn Disease, Inflammatory Bowel Diseases, Colorectal Cancer, Gastrointestinal Cancer, Gastrointestinal Disease, Digestive System Disease, Pain, Pain, Neuropathic, Intestinal Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 29, 2018
Enrollment StartOct 23, 2018
Primary CompletionOct 29, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.7 years ago

Interventions

Liposomal bupivacainedrug

Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.

Bupivacaine/epinephrine/dexamethasonedrug

Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.