CompletedPhase 2Other

Transverse Abdominis Plane Block for Anterior Approach Spine Surgery

Sponsored by Rennes University Hospital

NCT ID
NCT02884440
Target Enrollment
43 participants
Start Date
2016-11-07
Est. Completion
2019-05-25

About This Study

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

Conditions Studied

Spine SurgeryLow Back PainSpondylolisthesis

Interventions

  • TAP block ropivacaine
  • TAP block placebo
  • General anesthesia

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full 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

Study Locations (1)

CHU de Rennes
Rennes, France

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source