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

Phase 4

Completed

• Conditions: Cholecystectomy; Laparoscopy
• Interventions: Drug: Ropivacaine

• Registration Number: NCT02085902
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Status Verified: 2015-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard anesthesia with ropivacaine	Ropivacaine	ropivacaine

Primary Outcome Measures

Name	Time	Method
Time to discharge patient after surgery	6 hours postoperative

Trial Locations

Locations (1)

Centre hospitalier départemental Vendée; 🇫🇷 La Roche sur Yon, France