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

Phase 3

Withdrawn

• Conditions: Pain; Surgery
• Interventions: Drug: Ropivacaine administration; Drug: Sodium chloride administration

• Registration Number: NCT02819544
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Study Start: 2016-09
• Primary Completion: 2017-05-10
• Study Completion: 2017-05-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine administration	Ropivacaine 7.5 mg/mL administration
Sodium chloride	Sodium chloride administration	NaCl 0.9% administration

Primary Outcome Measures

Name	Time	Method
Pain measured by visual analog scale (VAS)	between first postoperative day and 6th postoperative day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

CHU Amiens; 🇫🇷 Amiens, France

CH Beauvais; 🇫🇷 Beauvais, France