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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cholecystectomy Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

standard anesthesia with ropivacaine

ropivacaine

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No