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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure 8 mmHg | Experimental |
| |
| Pressure 14 mmHg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cholecystectomy | Procedure | Laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain | Hour 6 |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | Visual Analog Scale (VAS) 0 no pain, 10 worst possible pain | Hour 12 |
| Postoperative pain | Visual Analog Scale 0 no pain, 10 worst possible pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amine Ben Safta, Assistant hospitalo-universita | Contact | +216 29 693 979 | amine.bsa@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41411326 | Derived | Ben Safta A, Nasri S, Samaali I, Taher H, Trabelsi MM, Dziri C, Dougaz W, Nouira R. Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol. PLoS One. 2025 Dec 18;20(12):e0339161. doi: 10.1371/journal.pone.0339161. eCollection 2025. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Hour 24 |
| vommiting (PONV score) | Postoperative Nausea and vomiting (PONV) score 0 no PONV , 1 moderate nausea, 2 moderate vomiting, 3 uncontrollable nausea and/or vomiting | from 0 to 24 hours after surgery |
| morbidity | 30 days |
| postoperative length of stay | 30 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |