Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery? (VesiRop)

May 18, 2015 updated by: Centre Hospitalier Departemental Vendee

Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting.

The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient.

Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • France
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Départemental VENDEE

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Programmed Cholecystectomy
  • Laparoscopy
  • Man and woman
  • ≥ 18
  • ASA 1 or 2
  • Not living alone
  • Patient receiving social security coverage
  • Signature of Informed Consent Form

Exclusion Criteria:

  • Cholecystectomy emergency
  • Patient minor
  • Pregnant woman (pregnancy test) or during breastfeeding
  • Conversion to laparotomy
  • Patient anticoagulant curative dose
  • Living alone
  • Patient addict
  • Peptic Ulcer
  • Refusal to enter the protocol
  • Chronic requiring analgesics long-term
  • Immunosuppression
  • Long-term Treatment with corticosteroids
  • Discovery intraoperative calculation in the bile duct
  • Contraindication to ropivacaine (see cons-indications to ropivacaine)
  • Hypersensitivity to study treatment or concomitant medications anesthesia
  • Cardiac or unbalanced epileptic patients (due to the risk of cardiovascular and neurological local anesthetics)
  • Patients ASA ≥ 3
  • Patient <50 kg

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard anesthesia
Experimental: standard anesthesia with ropivacaine
ropivacaine
Drug: Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to discharge patient after surgery
Time Frame: 6 hours postoperative
6 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Study Director: Emeric ABET, Dr, Chd Vendee La Roche Sur Yon

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.

General Publications

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

March 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 079-13

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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