Evaluation of the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care

NCT ID: NCT02819544

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-05-10

Brief Summary

Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.

In order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.

As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.

In recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.

However, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.

Conditions

Surgery; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ropivacaine

Ropivacaine 7.5 mg/mL administration

Group Type: ACTIVE_COMPARATOR

Ropivacaine administration

Intervention Type: DRUG

Ropivacaine administration

Sodium chloride

NaCl 0.9% administration

Group Type: PLACEBO_COMPARATOR

Sodium chloride administration

Intervention Type: DRUG

Sodium chloride administration

Interventions

Sodium chloride administration

Sodium chloride administration

Intervention Type: DRUG

Ropivacaine administration

Ropivacaine administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient aged 18 to 80 years
• Patients with biliary pathology requiring cholecystectomy
• Patients with signed consent
• Patient eligible to outpatient care
• No allergy to Naropin
• Support by laparoscopy
• Patients affiliated to a social security s

Exclusion Criteria

• Contraindications for laparoscopy
• Contraindications to outpatient surgery
• Patients with an allergy to paracetamol or tramadol
• Patient with an addiction to painkillers and / or alcohol
• Patient with a disease causing chronic pain
• Patient using analgesics bearing 1 , 2 or 3 chronically
• Pregnant or breastfeeding women , of reproductive age without effective contraception
• Minor Patient,
• Contraindication to surgery,
• Physical or psychological state does not allow the patient's participation in the study ,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc REGIMBEAU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens

Amiens, , France

CH Beauvais

Beauvais, , France

Countries

France

Other Identifiers

PI2015_843_0020

Identifier Type: -

Identifier Source: org_study_id