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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Surgery, Pain

Intervention / Treatment
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* Drug: Sodium chloride administration
* Drug: Ropivacaine administration


Participation Criteria
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Eligibility Criteria
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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 ,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine<br>Ropivacaine 7.5 mg/mL administration | Drug: Ropivacaine administration<br>* Ropivacaine administration<br>|
| Placebo Comparator: Sodium chloride<br>NaCl 0.9% administration | Drug: Sodium chloride administration<br>* Sodium chloride administration<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digestive System