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

Phase 4

Completed

• 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
• Interventions: Drug: Transversus Abdominis Plane; Drug: Curare

• Registration Number: NCT01628952
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Primary Completion: 2013-01
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• ASA IV

  • 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
  • Inability to understand and give informed consent
  • Patient under guardianship, curatorship or protected
  • Indication of use of a hypnotic ketamine (BIS change)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP	Transversus Abdominis Plane	-
curare	Curare	Patients will be randomized into two parallel groups. One group will receive curare, another benefit of a bilateral TAP block

Primary Outcome Measures

Name	Time	Method
Muscle relaxation.	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).

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, Picardie, France