Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Rennes University Hospital43 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Spine Surgery Low Back Pain Spondylolisthesis

Interventions

TAP block ropivacaineDRUG

TAP block placeboDRUG

General anesthesiaDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Rennes

Rennes, France

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

Morphine consumption in the first 48 hours after spine surgery by anterior approach

Time frame: 48 hours

Assessment of pain

Numerical Analogue score

Time frame: 1, 6, 12, 24 and 48 hours

Assessment of post operative nausea or vomiting

Occurence of nausea or vomiting episodes over 48 hours

Time frame: 48 hours

Delay before first morphine administration

Number of hours between end of surgery and first morphine administration

Time frame: Day 1

Delay before the first lift

Number of hours between end of surgery and the first lift

Time frame: Day 1

Delay before resumption of transit

Number of days between end of surgery and resumption of transit

Time frame: Day 1

Duration of hospitalization

Time frame: Day 1

Patient satisfaction

Satisfaction questionnaire

Time frame: 48 hours

Data from ClinicalTrials.gov

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