Transverse Abdominis Plane Block for Anterior Approach Spine Surgery (TAP ALIF)

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Spondylolisthesis; Spine Surgery
• Intervention / Treatment: Drug: TAP block ropivacaine; Drug: General anesthesia; Drug: TAP block placebo

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block ropivacaine; Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention	Drug: TAP block ropivacaine; 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
Placebo Comparator: TAP block placebo; Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention	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; Drug: TAP block placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine consumption in the first 24 hours after spine surgery by anterior approach	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Publications and helpful links

General Publications

• Coquet A, Sion A, Bourgoin A, Ropars M, Beloeil H. Transversus abdominis plane block for anterior lumbar interbody fusion: a randomized controlled trial. Spine J. 2023 Apr 7:S1529-9430(23)00151-1. doi: 10.1016/j.spinee.2023.03.013. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2016
• Primary Completion (Actual): May 25, 2019
• Study Completion (Actual): May 25, 2019

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Back Pain; Spondylolysis; Spondylosis; Low Back Pain; Spondylolisthesis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 35RC15_8933_TAP-ALIF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO