Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Morphine consumption in the first 24 hours after spine surgery by anterior approach
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TAP block ropivacaine
Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention
Intervention: TAP block ropivacaine (Drug)
TAP block ropivacaine
Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention
Intervention: General anesthesia (Drug)
TAP block placebo
Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention
Intervention: TAP block placebo (Drug)
TAP block placebo
Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention
Intervention: General anesthesia (Drug)
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(48 hours)
- Delay before the first lift(Day 1)
- Assessment of pain(1, 6, 12, 24 and 48 hours)
- Assessment of post operative nausea or vomiting(48 hours)
- Delay before first morphine administration(Day 1)
- Delay before resumption of transit(Day 1)
- Duration of hospitalization(Day 1)
- Patient satisfaction(48 hours)