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

• ClinicalTrials.gov Identifier: NCT02884440
• Recruitment Status: Completed
• First Posted: August 31, 2016
• Last Update Posted: February 7, 2020
• Sponsor: Rennes University Hospital
• Information provided by (Responsible Party): Rennes University Hospital

Tracking Information

• First Submitted Date: August 22, 2016
• First Posted Date: August 31, 2016
• Last Update Posted Date: February 7, 2020
• Actual Study Start Date: November 7, 2016
• Actual Primary Completion Date: May 25, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 25, 2016): Morphine consumption in the first 24 hours after spine surgery by anterior approach [ Time Frame: 24 hours ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 25, 2016)

• Morphine consumption in the first 48 hours after spine surgery by anterior approach [ Time Frame: 48 hours ]
• Assessment of pain [ Time Frame: 1, 6, 12, 24 and 48 hours ]
  Numerical Analogue score
• Assessment of post operative nausea or vomiting [ Time Frame: 48 hours ]
  Occurence of nausea or vomiting episodes over 48 hours
• Delay before first morphine administration [ Time Frame: Day 1 ]
  Number of hours between end of surgery and first morphine administration
• Delay before the first lift [ Time Frame: Day 1 ]
  Number of hours between end of surgery and the first lift
• Delay before resumption of transit [ Time Frame: Day 1 ]
  Number of days between end of surgery and resumption of transit
• Duration of hospitalization [ Time Frame: Day 1 ]
• Patient satisfaction [ Time Frame: 48 hours ]
  Satisfaction questionnaire

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Transverse Abdominis Plane Block for Anterior Approach Spine Surgery
• Official Title: Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Spine Surgery
• Low Back Pain
• Spondylolisthesis

Intervention

• Drug: TAP block ropivacaine
• Drug: TAP block placebo
• Drug: General anesthesia
  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

Study Arms

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

  • Drug: TAP block ropivacaine
  • Drug: General anesthesia
• Placebo Comparator: TAP block placebo
  Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention
  Interventions:

  • Drug: TAP block placebo
  • Drug: General anesthesia

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2020): 43
• Original Estimated Enrollment (submitted: August 25, 2016): 46
• Actual Study Completion Date: May 25, 2019
• Actual Primary Completion Date: May 25, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02884440
• Other Study ID Numbers: 35RC15_8933_TAP-ALIF
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Rennes University Hospital
• Study Sponsor: Rennes University Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rennes University Hospital
• Verification Date: February 2020