Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Ketamine

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

Intervention / Treatment

  • TAP block ropivacaine (DRUG)
    N/A
  • TAP block placebo (DRUG)
    N/A
  • General anesthesia (DRUG)
    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

Condition or Disease

  • Spine Surgery
  • Low Back Pain
  • Spondylolisthesis

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 43 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 07, 2016 ACTUAL
    Primary Completion: May 25, 2019 ACTUAL
    Completion Date: May 25, 2019 ACTUAL
    Study First Posted: Aug 31, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 22, 2023

    Sponsors / Collaborators

    Lead Sponsor: Rennes University Hospital
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Rennes, Brittany, France

    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

    Participant Groups

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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
    • Morphine consumption in the first 24 hours after spine surgery by anterior approach 24 hours
    Secondary Outcomes
    • Morphine consumption in the first 48 hours after spine surgery by anterior approach 48 hours

    • Numerical Analogue score

    • Occurence of nausea or vomiting episodes over 48 hours

    • Number of hours between end of surgery and first morphine administration

    • Number of hours between end of surgery and the first lift

    • Number of days between end of surgery and resumption of transit

    • Duration of hospitalization Day 1

    • Satisfaction questionnaire

    More Details

    NCT Number: NCT02884440
    Acronym: TAP ALIF
    Other IDs: 35RC15_8933_TAP-ALIF
    Study URL: https://clinicaltrials.gov/study/NCT02884440
    Last updated: Sep 29, 2023