Postoperative Pain
Conditions
Brief summary
Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy
Interventions
PROCEDURELaparoscopic cholecystectomy
Laparoscopic cholecystectomy
Sponsors
Hopital Charles Nicolle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA 1 or ASA 2 * uncomplicated symptomatic gallblader lithiasis scheduled for elective surgery * no choledocholithiasis * no associated surgical procedures * no cerebrovasculare accident with neurological sequelae or other neurological disorders that affects sensation of pain * no ascites * no carcinomatosis
Exclusion criteria
* conversion to laparotomy * need to keep an escat drain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Hour 6 | Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | Hour 12 | Visual Analog Scale (VAS) 0 no pain, 10 worst possible pain |
| Postoperative pain | Hour 24 | Visual Analog Scale 0 no pain, 10 worst possible pain |
| vommiting (PONV score) | from 0 to 24 hours after surgery | Postoperative Nausea and vomiting (PONV) score 0 no PONV , 1 moderate nausea, 2 moderate vomiting, 3 uncontrollable nausea and/or vomiting |
| morbidity | 30 days | — |
| postoperative length of stay | 30 days | — |
Contacts
Primary ContactAmine Ben Safta, Assistant hospitalo-universita
Outcome results
None listed