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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003219-53 | EudraCT Number |
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The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard analgesic therapy: iv Metamizol 2 g q8h | |
| TAP | Experimental | Transverse abdominal plain (TAP) blockade with local anesthetic: Bupivacaine chlorhydrate 0.25% adjusted by weight and type of surgery. Maximum dose: 150 mg of bupivacaine. Two approaches are done: 1)Posterior TAP: the needle insertion point is cephalad to the iliac crest, behind the midaxillary line. The needle is inserted under ultrasound guidance in plane. Local anesthetics is deposited between the internal oblique and transversus abdominis muscles, 2)Subcostal TAP: the needle is inserted ultrasound guided perpendicularly to abdominal wall, directed parallel to the costal margin but oblique to the sagittal plane. Local anesthestic is deposited between transversus abdominis and the rectus abdominis muscles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postoperative transverse abdominal plain (TAP) blockade | Procedure | Bupivacaine 0.25%. Maximum 150 mg. A maximum of 75 mg bupivacaine is administered in each side (posterior and subcostal TAP) in a single puncture. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level | Pain is assessed by numerical scale (0 to 10) where 0 is no pain and 10 is the most intense pain possible. Pain will be assessed at 4, 6 , 8, 12 and 24 hours. | Change in pain from admittance to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic consumption as a rescue therapy | Analgesic consumption: morphine in miligrams. | within 24 postoperative hours |
| Incidence of postoperative nausea and vomiting (PONV) related to therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Francisco Mayoral, MD | Fundació Puigvert (IUNA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Puigvert | Barcelona | Barcelona | 08025 | Spain |
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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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Assessment of PONV incidence and antiemetic drugs consumption.
| within 24 postoperative hours |
| Incidence of urethral/bladder spasm | Pain due to bladder catheter. | within 24 postoperative hours |
| Assessment of oral intake tolerance | Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours. | within 24 postoperative hours |
| Patient satisfaction | Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased | within 24 postoperative hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |