- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01628952
Comparison of the Bilateral TAP Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study
November 17, 2025 updated by: Centre Hospitalier Universitaire, Amiens
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Picardie
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Amiens, Picardie, France, 80054
- CHU Amiens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TAP
|
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
|
IAP coelioscopic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
20 minutes after anesthesia induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hervé DUPONT, PU-PH, CHU Amiens France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
June 25, 2012
First Submitted That Met QC Criteria
June 26, 2012
First Posted (Estimated)
June 27, 2012
Study Record Updates
Last Update Posted (Estimated)
November 19, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2012_843_0007
- 2012-000673-23 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Transversus Abdominis Plane
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Mackay Memorial HospitalRecruitingLaparoscopy | Anesthesia and Analgesia | Autonomic Nervous System | Nerve Block | EEGTaiwan
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Ain Shams UniversityCompletedMobility | Transversus Abdominis Plane Block | Wearable Device | Anterior Iliac Grafting | Regional Block TechniqueEgypt
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Tanta UniversityCompletedNephrectomy | Transversus Abdominis Plane Block | Postoperative Analgesia | External Oblique Intercostal Plane BlockEgypt
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Samsun UniversityCompletedCaesarean Section | Acute Pain ManagementTurkey