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 (VSD)

Centre Hospitalier Universitaire, Amiens

Status and phase: Withdrawn; Phase 3

Conditions: Surgery; Pain

Treatments: Drug: Ropivacaine administration; Drug: Sodium chloride administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02819544

PI2015_843_0020

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 ,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Ropivacaine

Active Comparator group

Description:

Ropivacaine 7.5 mg/mL administration

Treatment:

Drug: Ropivacaine administration

Sodium chloride

Placebo Comparator group

Description:

NaCl 0.9% administration

Treatment:

Drug: Sodium chloride administration