Clinical trial NCT02819544: 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
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Surgery
Pain
Keywords: Digestive System
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 ,

Primary outcomes:
measure: Pain measured by visual analog scale (VAS)
timeFrame: between first postoperative day and 6th postoperative day
Secondary outcomes:
measure: global pain measured by BPI (Brief Pain Inventory) scale
timeFrame: 30th postoperative day
measure: analgesics use
timeFrame: 30th postoperative day
measure: global morbidity
timeFrame: 30th postoperative day
measure: specific complications for each treatment
timeFrame: 30th postoperative day
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Beauvais
country: France
facility: CH Beauvais
Study officials:
affiliation: CHU Amiens
name: Jean-Marc REGIMBEAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: