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
Overview
- Phase
- Phase 3
- Intervention
- Ropivacaine administration
- Conditions
- Surgery
- Sponsor
- Centre Hospitalier Universitaire, Amiens
- Locations
- 2
- Primary Endpoint
- Pain measured by visual analog scale (VAS)
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
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 ,
Arms & Interventions
Ropivacaine
Ropivacaine 7.5 mg/mL administration
Intervention: Ropivacaine administration
Sodium chloride
NaCl 0.9% administration
Intervention: Sodium chloride administration
Outcomes
Primary Outcomes
Pain measured by visual analog scale (VAS)
Time Frame: between first postoperative day and 6th postoperative day
Secondary Outcomes
- 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)