Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2019-05-25

Brief Summary

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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

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Detailed Description

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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

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Spine Surgery Low Back Pain Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TAP block ropivacaine

Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention

Group Type EXPERIMENTAL

TAP block ropivacaine

Intervention Type DRUG

General anesthesia

Intervention Type DRUG

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

TAP block placebo

Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention

Group Type PLACEBO_COMPARATOR

TAP block placebo

Intervention Type DRUG

General anesthesia

Intervention Type DRUG

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

Interventions

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TAP block ropivacaine

Intervention Type DRUG

TAP block placebo

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No