Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery
|Postoperative Pain||Procedure: Postoperative transverse abdominal plain (TAP) blockade||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.|
- Pain level [ Time Frame: Change in pain from admittance to 24 hours postoperatively ]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.
- Analgesic consumption as a rescue therapy [ Time Frame: within 24 postoperative hours ]Analgesic consumption: morphine in miligrams.
- Incidence of postoperative nausea and vomiting (PONV) related to therapy [ Time Frame: within 24 postoperative hours ]Assessment of PONV incidence and antiemetic drugs consumption.
- Incidence of urethral/bladder spasm [ Time Frame: within 24 postoperative hours ]Pain due to bladder catheter.
- Assessment of oral intake tolerance [ Time Frame: within 24 postoperative hours ]Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.
- Patient satisfaction [ Time Frame: within 24 postoperative hours ]Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased
|Study Start Date:||December 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
No Intervention: Control
Standard analgesic therapy: iv Metamizol 2 g q8h
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.
Procedure: Postoperative transverse abdominal plain (TAP) blockade
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.
Other Name: Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501565
|Barcelona, Spain, 08025|
|Principal Investigator:||Juan Francisco Mayoral, MD||Fundació Puigvert (IUNA)|