Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Postoperative transverse abdominal plain (TAP) blockade

• Registration Number: NCT01501565
• Lead Sponsor: Fundacio Puigvert

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2011-12-27
• Study First Posted: 2011-12-29
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• > 18 yrs.
• Patients undergo laparoscopic urologic surgery
• Physical status ASA < 3
• Surgical procedure without complications
• Signed informed consent

Exclusion Criteria

• Allergy to bupivacaine chlorhydrate
• Patients with chronic pain treatment
• Alcoholism
• Decompensated hepatic disease
• Coagulation disorders
• BMI > 35
• Patient involved in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TAP	Postoperative transverse abdominal plain (TAP) blockade	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.

Primary Outcome Measures

Name	Time	Method
Pain level	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.

Secondary Outcome Measures

Name	Time	Method
Analgesic consumption as a rescue therapy	within 24 postoperative hours	Analgesic consumption: morphine in miligrams.
Incidence of postoperative nausea and vomiting (PONV) related to therapy	within 24 postoperative hours	Assessment of PONV incidence and antiemetic drugs consumption.
Incidence of urethral/bladder spasm	within 24 postoperative hours	Pain due to bladder catheter.
Assessment of oral intake tolerance	within 24 postoperative hours	Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.
Patient satisfaction	within 24 postoperative hours	Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased

Trial Locations

Locations (1)

Fundació Puigvert; 🇪🇸 Barcelona, Spain