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Completed

NCT Number: NCT02884440

Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP block ropivacaine

Drug

TAP block placebo

Drug

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

Primary outcomes

  1. Morphine consumption in the first 24 hours after spine surgery by anterior approach

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study

Acronym: TAP ALIF

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2016
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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