CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 127 enrolled
Drug / intervention
US TAP Bupivacaine/Epinephrine +2 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/NCT02538679
NCT02538679N/ACompleted

A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Technique Versus Laparoscopic Transversus Abdominis Plane Nerve Block Technique Versus No Block on Postoperative Opioid Consumption After Major Colorectal Surgery

Cedars-Sinai Medical Center·interventional·Posted Sep 2, 2015·Updated Mar 27, 2018

In Brief

A clinical study evaluating Placebo, US TAP Bupivacaine/Epinephrine, and 1 other intervention for Crohn's Disease and 2 related conditions. Completed, enrolled 127 participants.

Detailed Summary

Postoperative pain can pose significant challenges in the postoperative recovery of patients undergoing major colorectal surgery. Traditionally, opioids have played an important role in treating postoperative pain. It is well established that opioids are highly effective in relieving pain; however opioids are associated with numerous side effects that include nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus, drowsiness, sedation, and allergic reaction. These opioid side effects, which range in severity, can significantly interfere with discharge home following colorectal surgery. Significant interest exists in the use of local anesthetic based regional anesthesia techniques as a means to extend the analgesic window for patients undergoing colorectal surgery. Specifically, the use of the transversus abdominis plane (TAP) block as an adjunct in postoperative pain control has been widely reported in the anesthesia and colorectal surgery literature. Historically, the block was performed in a blind fashion with relative success and presently the block is typically performed either with ultrasound guidance or laparoscopic visualization. While TAP block has shown to be effective in post-operative pain control, the techniques used to place the block have not formally been compared. The investigators are purposing a prospective, patient-blinded, randomized study of patients undergoing major colorectal surgery to compare TAP block under ultrasound guidance versus laparoscopic visualization versus no TAP block. The investigators hypothesize that laparoscopic-guided TAP block is non-inferior to ultrasound-guided TAP block with respect to perioperative pain control and either technique is superior to no TAP. In addition the investigators will measure procedural time, any adverse events related to the block, overall postoperative analgesic requirement, analgesic duration, postoperative pain scores, length of postoperative hospital stay, incidence of postoperative ileus, and overall patient satisfaction between the three groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2, 2015
Enrollment StartAug 7, 2015
Primary CompletionApr 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.8 years ago

Interventions

Placeboother

The usual intraoperative and postoperative pain control; NO TAP block performed

US TAP Bupivacaine/Epinephrinedrug

Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.

Lap TAP Bupivacaine/Epinephrinedrug

Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.