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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02884440
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Tracking Information
First Submitted Date  ICMJE August 22, 2016
First Posted Date  ICMJE August 31, 2016
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE November 7, 2016
Actual Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transverse Abdominis Plane Block for Anterior Approach Spine Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spine Surgery
  • Low Back Pain
  • Spondylolisthesis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2020)
43
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2016)
46
Actual Study Completion Date  ICMJE May 25, 2019
Actual Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02884440
Other Study ID Numbers  ICMJE 35RC15_8933_TAP-ALIF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rennes University Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP