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Clinical Trials/NCT01628952
NCT01628952
Completed
Phase 4

Comparison of the Bilateral Transversus Abdominis Plane (TAP) Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study

Centre Hospitalier Universitaire, Amiens1 site in 1 country60 target enrollmentJune 1, 2012

Overview

Phase
Phase 4
Intervention
Transversus Abdominis Plane
Conditions
The Main of This Study is to Compare the Nerve Block of the Muscles of the Abdominal Wall Between the Bilateral TAP Block and Curare
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
60
Locations
1
Primary Endpoint
Muscle relaxation.
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric, phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of the abdominal wall during laparoscopic digestive surgery.

Registry
clinicaltrials.gov
Start Date
June 1, 2012
End Date
January 2013
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients older than 18 years and under 75 years
  • Informed consent signed
  • ASA I, II and III
  • Patient affiliated to social security

Exclusion Criteria

  • BMI\> 35 kg / m
  • Personal or family history of malignant hyperthermia
  • History of allergy or hypersensitivity to intravenous anesthetics (remifentanil), local anesthetics or muscle relaxants
  • Contraindications to sevoflurane: a history of malignant hyperthermia, history of liver disease after sevoflurane anesthesia, halogenated agents or hypersensitivity to any of these components.
  • Contraindications to succinylcholine: hyperkalemia, plasma cholinesterase deficiency nickname, para or tetraplegia more than 24 hours, burns over 24
  • Contraindications to cisatracurium: myasthenia
  • Neuromuscular diseases
  • Contraindications to local anesthetics: hypersensitivity to local anesthetics of the amide, intravenous regional anesthesia, porphyria, ventricular atrial conduction disturbances, epilepsy uncontrolled by treatment
  • Pregnancy and lactation
  • severe coagulation disorders

Arms & Interventions

TAP

Intervention: Transversus Abdominis Plane

curare

Patients will be randomized into two parallel groups. One group will receive curare, another benefit of a bilateral TAP block

Intervention: Curare

Outcomes

Primary Outcomes

Muscle relaxation.

Time Frame: 20 minutes after anesthesia induction

Muscle relaxation of the abdominal wall will be evaluated based on the amount of volume infused initially to create the pneumoperitoneum. This parameter is given by the unit of laparoscopy and allow us to calculate the abdominal compliance (C = ΔV / Ap).

Study Sites (1)

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