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

Laparoscopy Clinical Trial

— VesiRop  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085902
• Other study ID #: CHD 079-13
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2014
• Last updated: May 18, 2015
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cholecystectomy
• Laparoscopy

Intervention

Drug:
• Ropivacaine

Locations

Country	Name	City	State
France	Centre hospitalier départemental Vendée	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to discharge patient after surgery		6 hours postoperative	No