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

35RC15_8933_TAP-ALIF

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

2016-11-07

2019-05-25

2019-05-25

Completed

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}

2023-05-24