Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Phase 2

Completed

• Conditions: Spine Surgery; Low Back Pain; Spondylolisthesis
• Interventions: Drug: TAP block ropivacaine; Drug: TAP block placebo; Drug: General anesthesia

• Registration Number: NCT02884440
• Lead Sponsor: Rennes University Hospital

Brief 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

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-31
• Study Start: 2016-11-07
• Primary Completion: 2019-05-25
• Study Completion: 2019-05-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Patient with age above 18 years old
• Patients scheduled for spine surgery by anterior approach
• Patient who signed an informed consent form

Exclusion Criteria

• Allergy to ropivacaine
• Weight < 50 kg
• Contra indication to TAP block : sepsis in the point of draining, bleeding disorder
• Contra indication to paracetamol: severe hepatic insufficiency
• Contra indication to ketoprofen: age ≥ 75 years, renal insufficiency, previous gastric ulcer, allergy
• Contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, allergy
• Known allergy to active substance or at least to one excipient (propofol, paracetamol, morphine, remifentanil, cisatracurium)
• Allergy to fentanyl, atracurium, or benzin sulfonic acid derivative, to propacetamol
• Convulsions or previous convulsive disorder
• Severe respiratory insufficiency
• Abnormal hemostasis or anticoagulant treatment because of possible intramuscular injection
• Morphine intake 24 hours before surgery
• Chronic use of morphine, gabapentin, pregabalin
• Pregnancy or breastfeeding
• Patient unable to use Patient Controlled Analgesia (PCA) (old patient depends...)
• Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block placebo	General anesthesia	Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention
TAP block ropivacaine	TAP block ropivacaine	Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention
TAP block ropivacaine	General anesthesia	Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention
TAP block placebo	TAP block placebo	Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention

Primary Outcome Measures

Name	Time	Method
Morphine consumption in the first 24 hours after spine surgery by anterior approach	24 hours

Secondary Outcome Measures

Name	Time	Method
Morphine consumption in the first 48 hours after spine surgery by anterior approach	48 hours
Delay before the first lift	Day 1	Number of hours between end of surgery and the first lift
Assessment of pain	1, 6, 12, 24 and 48 hours	Numerical Analogue score
Assessment of post operative nausea or vomiting	48 hours	Occurence of nausea or vomiting episodes over 48 hours
Delay before first morphine administration	Day 1	Number of hours between end of surgery and first morphine administration
Delay before resumption of transit	Day 1	Number of days between end of surgery and resumption of transit
Duration of hospitalization	Day 1
Patient satisfaction	48 hours	Satisfaction questionnaire

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France