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For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trocar-site infiltration | Experimental | Trocar-site infiltration with 20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 5 mm trocar site) associated with bilateral TAP block with 20 mL of normal saline in each side |
|
| TAP block | Active Comparator | Trocar-site infiltration with 20 mL of normal saline associated with bilateral TAP block with 20 mL of ropivacaine 0.375% in each side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trocar-site infiltration | Procedure | 20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute postoperative pain | Visual analog scale (VAS) 0: "no pain" to 10: "severe pain" at rest and cough | up to 24 hours |
| Total opioid consumption | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | up to 1 week | |
| postoperative nausea and vomiting | Day 1 | |
| Patient satisfaction and quality of recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DAGHMOURI Mohamed Aziz, M.D | Contact | 0029442474 | aziz.daghmouri@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| BEN FADHEL Kamel, M.D | Habib Thameur Hospital of Tunis, Department of Anesthesia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Habib Thameur Hospital | Recruiting | Tunis | Tunisia |
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| TAP block | Procedure | bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side |
|
| Trocar site infiltration placebo | Procedure | 20 mL of normal saline |
|
| TAP block placebo | Procedure | bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side |
|
QoR-40 questionnaire |
| Day 1 |
| Incidence of shoulder pain | Day 1 |
| Postoperative complication | Ileus, wound infection, wound abscess | up to 1 week |