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

NCT02819544 | Withdrawn Phase 3

• 1 other identifier: PI2015_843_0020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Digestive System

Outcome Measures

Primary Outcomes (1)

• Pain measured by visual analog scale (VAS)

  between first postoperative day and 6th postoperative day

Secondary Outcomes (4)

• 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

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

Ropivacaine 7.5 mg/mL administration

Drug: Ropivacaine administration

Sodium chloride

PLACEBO COMPARATOR

NaCl 0.9% administration

Drug: Sodium chloride administration

Interventions

Sodium chloride administration DRUG

Sodium chloride administration

Sodium chloride

Ropivacaine administration DRUG

Ropivacaine administration

Ropivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 ,

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (2)

CHU Amiens

Amiens, 80054, France

Location

CH Beauvais

Beauvais, 60000, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Marc REGIMBEAU, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: September 1, 2016
• Primary Completion: May 10, 2017
• Study Completion: May 10, 2017
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

FR (2)