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

NCT02085902 | Completed Phase 4

• 1 other identifier: CHD 079-13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystectomy; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Time to discharge patient after surgery

  6 hours postoperative

Study Arms (2)

standard anesthesia

NO INTERVENTION

standard anesthesia with ropivacaine

EXPERIMENTAL

ropivacaine

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

standard anesthesia with ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

Centre hospitalier départemental Vendée

La Roche-sur-Yon, 85925, France

Location

Related Publications (1)

• Abet E, Orion F, Denimal F, Brau-Weber AG, de Kerviler B, Jean MH, Boulanger G, Dimet J, Comy M. Interest of Using Ropivacaine for Outpatient Laparoscopic Cholecystectomy: Prospective Randomized Trial. World J Surg. 2017 Mar;41(3):687-692. doi: 10.1007/s00268-016-3797-2.

  PMID: 27872974 RESULT

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Emeric ABET, Dr

  CHD Vendée La Roche sur Yon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 13, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)