Clinical trial NCT02884440: Transverse Abdominis Plane Block for Anterior Approach Spine Surgery
Official title: Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spine Surgery
Low Back Pain
Spondylolisthesis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption in the first 24 hours after spine surgery by anterior approach
timeFrame: 24 hours
Secondary outcomes:
measure: Morphine consumption in the first 48 hours after spine surgery by anterior approach
timeFrame: 48 hours
measure: Assessment of pain
timeFrame: 1, 6, 12, 24 and 48 hours
measure: Assessment of post operative nausea or vomiting
timeFrame: 48 hours
measure: Delay before first morphine administration
timeFrame: Day 1
measure: Delay before the first lift
timeFrame: Day 1
measure: Delay before resumption of transit
timeFrame: Day 1
measure: Duration of hospitalization
timeFrame: Day 1
measure: Patient satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
citation: Coquet A, Sion A, Bourgoin A, Ropars M, Beloeil H. Transversus abdominis plane block for anterior lumbar interbody fusion: a randomized controlled trial. Spine J. 2023 Aug;23(8):1137-1143. doi: 10.1016/j.spinee.2023.03.013. Epub 2023 Apr 7.