The Main of This Study is to Compare the Nerve Block of the Muscles of the Abdominal Wall Between the Bilateral TAP Block and CurarePhase 4NCT01628952

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

A Phase 4 study testing Transversus Abdominis Plane and Curare in people with 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, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: 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
What is being tested?: Transversus Abdominis Plane and Curare
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteFrance
Study dates: 4 Oct 2012to 27 Mar 2013
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Amiens
Amiens, Picardie, 80054

Other trials in France

About this study

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

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
Being tested: Transversus Abdominis Plane, Curare

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transversus Abdominis PlaneDrug
PIA coelioscopic
CurareDrug
IAP coelioscopic

Study groups in NCT01628952
Study group	Role	What they receive
TAP	Experimental	Not described Receives: Drug: Transversus Abdominis Plane
curare	Active comparator	Patients will be randomized into two parallel groups. One group will receive curare, another benefit of a bilateral TAP block Receives: Drug: Curare

What is being measured

The primary outcome is the main question the study is designed to answer.

Muscle relaxation.
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).
Measured: 20 minutes after anesthesia induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 201227 Mar 2013

First posted27 Jun 2012 (estimated)
Study start4 Oct 2012
Primary completion30 Jan 2013
Study completion27 Mar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for The Main of This Study is to Compare the Nerve Block of the Muscles of the Abdominal Wall Between the Bilateral TAP Block and CurareStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01628952
Sponsor's protocol ID: PI2012_843_0007
Other IDs: 2012-000673-23
Status last verified: Jun 2026
First submitted: 25 Jun 2012
Last updated: 12 Jun 2026
Results posted: No
Data monitoring committee: No

Publications

From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.
PubMed 29786478

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01628952
Acronym / sponsor ID: PI2012_843_0007
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
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
Study start: 4 Oct 2012 (actual)
Primary completion: 30 Jan 2013 (actual)
Study completion: 27 Mar 2013 (actual)
First posted: 27 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
TAP	Experimental	Drug: Transversus Abdominis Plane
curare	Active comparator	Drug: CurarePatients will be randomized into two parallel groups. One group will receive curare, another benefit of a bilateral TAP block

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (14 listed)

ASA IV

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transversus Abdominis PlanePIA coelioscopic	Drug	TAP
CurareIAP coelioscopic	Drug	curare

Primary outcome

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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Results publication: PubMed 29786478From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hervé DUPONT, PU-PH study director

CHU Amiens France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle relaxation. (time frame: 20 minutes after anesthesia induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01628952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.