TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study — TAP-LIF  

Pain, Postoperative Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Clinical trial : therapeutic, prospective, randomized,double blind, placebo-controlled, with parallel group, of superiority, in intention to treat, monocentric study.

The main steps of the study are:

• preoperative assessment of eligibility

• exclusion and inclusion criteria, written informed consent, baseline preoperative assessment (see specific section)

• randomization (using a computer generated list) immediately before induction of anesthesia

• TAP block: ropivacaine + clonidine (experimental group, n=20) OR saline (control group; n=20)

• anesthesia (propofol, sufentanil, cisatracurium, ketamine and desflurane) and postoperative analgesia (paracetamol, ketoprofen, nefopam, and patient-controlled analgesia with morphine) similar in both groups

• surgical procedure

• primary outcome parameter (morphine consumption first 24 hours; see specific section)

• secondary endpoints (see specific section, up to 6 months following surgery) ;

Related Conditions & MeSH terms

• Pain, Postoperative

• NCT number: NCT02778178
• Study type: Interventional
• Source: University Hospital, Lille
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2016
• Completion date: April 2017