NCT02884440

Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption

Detailed description

ALIF is a commonly performed procedure for the treatment of degenerative diseases of the lumbar spine or spondylolisthesis. This technique has many advantages attributed to the absence of posterior spinal muscular pain, a more direct visualization of the disk space, lower incidence of neurological injuries… However, patients experienced moderate to high post operative parietal abdominal pain due to this specific anterior approach. The systematic need for opioids administration may cause many complications and delay the post operative recovery time. The TAP block has been described as an effective pain control technique after various lower abdominal surgeries, reducing both pain scores and 24 hours opioids consumption. However the analgesic efficacy of this technique on specific parietal abdominal pain experienced after spine surgery by anterior approach is not clear

Conditions

• Spine Surgery
• Low Back Pain
• Spondylolisthesis

Interventions

Type	Name	Description
DRUG	TAP block ropivacaine
DRUG	TAP block placebo
DRUG	General anesthesia	Induction PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml CISATRACURIUM 2mg/ml if necessary DEXAMETHASONE 8 mg KETAMINE 0,15mg/kg Maintenance PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml

Timeline

• Start date: 2016-11-07
• Primary completion: 2019-05-25
• Completion: 2019-05-25
• First posted: 2016-08-31
• Last updated: 2023-05-24

Locations

1 site across 1 country: France