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

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ClinicalTrials.gov Identifier: NCT02884440
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment Phase
Spine Surgery Low Back Pain Spondylolisthesis Drug: TAP block ropivacaine Drug: TAP block placebo Drug: General anesthesia Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study
Actual Study Start Date : November 7, 2016
Estimated Primary Completion Date : May 7, 2020
Estimated Study Completion Date : November 7, 2020

Arm Intervention/treatment
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
Drug: TAP block ropivacaine
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

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




Primary Outcome Measures :
  1. Morphine consumption in the first 24 hours after spine surgery by anterior approach [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Morphine consumption in the first 48 hours after spine surgery by anterior approach [ Time Frame: 48 hours ]
  2. Assessment of pain [ Time Frame: 1, 6, 12, 24 and 48 hours ]
    Numerical Analogue score

  3. Assessment of post operative nausea or vomiting [ Time Frame: 48 hours ]
    Occurence of nausea or vomiting episodes over 48 hours

  4. Delay before first morphine administration [ Time Frame: Day 1 ]
    Number of hours between end of surgery and first morphine administration

  5. Delay before the first lift [ Time Frame: Day 1 ]
    Number of hours between end of surgery and the first lift

  6. Delay before resumption of transit [ Time Frame: Day 1 ]
    Number of days between end of surgery and resumption of transit

  7. Duration of hospitalization [ Time Frame: Day 1 ]
  8. Patient satisfaction [ Time Frame: 48 hours ]
    Satisfaction questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884440


Contacts
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Contact: Audrey Sion, MD 33 2 99 28 43 21 audrey.sion@chu-rennes.fr
Contact: Hélène Beloeil, MD, PhD 33 2 99 28 24 22 helene.beloeil@chu-rennes.fr

Locations
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France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Audrey Sion, MD         
Contact: Hélène Beloeil, MD, PhD         
Sponsors and Collaborators
Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02884440     History of Changes
Other Study ID Numbers: 35RC15_8933_TAP-ALIF
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spondylolisthesis
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents