Laparoscopic-guided Transversus Abdominis Plane (TAP) Block for Postoperative Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
| Registry | NCT03203070 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 200 (Estimated) |
| Sponsor | Hospital General Universitario Elche (Other) |
| Conditions | Pain, Postoperative |
| Interventions | Metamizol iv, TAP block (Drug, procedure) |
| Dates | start 2017-03-01, primary completion 2017-09-01 (estimated), completion 2017-09-01 (estimated), first posted 2017-06-29, last updated 2017-06-29 |
| Locations | 1 site in Spain |
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A prospective randomized trial will be performed. Patients undergoing gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia, and patients receiving only postoperative intravenous analgesia (Group 2).
Postoperative pain will be assessed with a Visual Analogic Scale 24h after surgery and morphine needs will be quantified.
A prospective randomized trial will be performed. Patients undergoing laparoscopic Roux-en-Y gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided TAP block with 30 ml Bupivacaine 0.5%, as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h), and patients receiving only postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h) (Group 2).
Postoperative pain will be assessed with a Visual Analogic Scale 24 hours after surgery and morphine needs will be quantified.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Metamizol iv | Active comparator | Drug: Metamizol iv | The patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain. |
| TAP block | Experimental | Drug: Metamizol iv; Procedure: TAP block | The patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain. |
Sex: All
Inclusion Criteria: * Body mass index (BMI) >40 Kg/m2 * BMI >35 Kg/m2 and obesity associated comorbidities * Patients undergoing laparoscopic Roux en Y gastric bypass Exclusion Criteria: * Patients undergoing other bariatric procedures, different than Roux en Y gastric bypass * Patients undergoing open bariatric surgery
| Facility | City | Country | Status |
|---|---|---|---|
| General Hospital Elche | Elche, Alicante | Spain | Recruiting |