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

Pain Clinical Trial

— VSD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02819544
• Other study ID #: PI2015_843_0020
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: May 10, 2017

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 10, 2017
• Est. primary completion date: May 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ,

Related Conditions & MeSH terms

• Pain
• Surgery

Intervention

Drug:
• Sodium chloride administration
Sodium chloride administration
• Ropivacaine administration
Ropivacaine administration

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CH Beauvais	Beauvais

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured by visual analog scale (VAS)		between first postoperative day and 6th postoperative day
Secondary	global pain measured by BPI (Brief Pain Inventory) scale		30th postoperative day
Secondary	analgesics use		30th postoperative day
Secondary	global morbidity		30th postoperative day
Secondary	specific complications for each treatment		30th postoperative day