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

Rennes University Hospital

Status and phase: Completed; Phase 2

Conditions: Spine Surgery; Spondylolisthesis; Low Back Pain

Treatments: Drug: TAP block ropivacaine; Drug: General anesthesia; Drug: TAP block placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02884440

35RC15_8933_TAP-ALIF

Details and patient eligibility

About

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

Full 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

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

TAP block ropivacaine

Experimental group

Description:

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

Treatment:

Drug: General anesthesia

Drug: TAP block ropivacaine

TAP block placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: General anesthesia

Drug: TAP block placebo