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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01628952
First received: June 25, 2012
Last updated: March 19, 2013
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
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
 Drug: Transversus Abdominis Plane
Drug: Curare
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Muscle relaxation. [ Time Frame: 20 minutes after anesthesia induction ] [ Designated as safety issue: No ]
    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).


Enrollment: 60
Study Start Date: June 2012
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP Drug: Transversus Abdominis Plane
PIA coelioscopic
Active Comparator: curare
Patients will be randomized into two parallel groups. One group will receive curare, another benefit of a bilateral TAP block
 Drug: Curare
IAP coelioscopic

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628952

Locations
France
CHU Amiens
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Study Director: Hervé DUPONT, PU-PH CHU Amiens France
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01628952     History of Changes
Other Study ID Numbers: PI2012_843_0007, 2012-000673-23
Study First Received: June 25, 2012
Last Updated: March 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Curare
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013