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 (VSD)

Prospective, Two-center , Randomized, ITT , Parallel Group Evaluating 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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain; Surgery
• Intervention / Treatment: Drug: Ropivacaine administration; Drug: Sodium chloride administration

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens
  • Beauvais, France, 60000
    • CH Beauvais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine; Ropivacaine 7.5 mg/mL administration	Drug: Ropivacaine administration; Ropivacaine administration
Placebo Comparator: Sodium chloride; NaCl 0.9% administration	Drug: Sodium chloride administration; Sodium chloride administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain measured by visual analog scale (VAS)	between first postoperative day and 6th postoperative day

Secondary Outcome Measures

Outcome Measure	Time Frame
global pain measured by BPI (Brief Pain Inventory) scale	30th postoperative day
analgesics use	30th postoperative day
global morbidity	30th postoperative day
specific complications for each treatment	30th postoperative day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Jean-Marc REGIMBEAU, MD, PhD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 10, 2017
• Study Completion (Actual): May 10, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Digestive System
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: PI2015_843_0020