Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Study Overview
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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

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

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

Conditions
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Spine Surgery, Low Back Pain, Spondylolisthesis

Intervention / Treatment
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* Drug: TAP block ropivacaine
* Drug: TAP block placebo
* Drug: General anesthesia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP block ropivacaine<br>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<br> <br> Drug: General anesthesia<br>* 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<br>|
| Placebo Comparator: TAP block placebo<br>Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention | Drug: TAP block placebo<br> <br> Drug: General anesthesia<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |