CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
ropivacaine plus clonidine +2 moredrug
Likely dose
ropivacaine plus clonidine 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/NCT02778178
NCT02778178Phase 4Completed

Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block After Lumbar Spine Surgery Through Anterior Approach (Anterior Lumbar or Direct Lateral Interbody Fusion): a Prospective, Randomized, Double-blind Placebo-controlled Study

University Hospital, Lille·interventional·Posted May 19, 2016·Updated May 19, 2017

In Brief

A Phase 4 clinical trial evaluating ropivacaine plus clonidine, Placebo, and 1 other intervention for Pain, Postoperative. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. However, the additional anterior approach conveys specific concerns, including abdominal pain that may delay recovery after surgery. The transversus abdominis plane (TAP) block is a validated approach for postoperative pain relief following abdominal surgeries. There is currently no evidence of the possible benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind, placebo-controlled study is to demonstrate a \>35% reduction in opioid consumption during the 24h following ALIF/DLIF surgery.

Study Details

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

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 19, 2016
Enrollment StartMay 2, 2016
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.1 years ago

Interventions

ropivacaine plus clonidinedrug

20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side

Placebodrug

20 mL saline 0.9%, per side

ultrasounddevice