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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

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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02819544
Acronym
VSD
Enrollment
0
Registered
2016-06-30
Start date
2016-09-30
Completion date
2017-05-10
Last updated
2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Surgery

Keywords

Digestive System

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.

Interventions

Sodium chloride administration

DRUGRopivacaine administration

Ropivacaine administration

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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 ,

Design outcomes

Primary

MeasureTime frame
Pain measured by visual analog scale (VAS)between first postoperative day and 6th postoperative day

Secondary

MeasureTime frame
global pain measured by BPI (Brief Pain Inventory) scale30th postoperative day
analgesics use30th postoperative day
global morbidity30th postoperative day
specific complications for each treatment30th postoperative day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026