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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Treatments: Clonidine; Ropivacaine

Criteria

Inclusion Criteria:

• Man or woman over the age of 18 yr

• Patients with insurance coverage

• Patients able to provide free and informed consent

• Patients undergoing surgery by the ALIF or DLIF approaches

Exclusion Criteria:

• Patients receiving opioids as chronic treatment

• Patients with contra-indication to regional anesthesia or TAP block

• Patients unable to consent

• Patient refusal

• Patients with contra-indication to any drug included in the anesthesia or analgesia protocol

• Pregnancy or breast-feeding women