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

Puigvert Foundation

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Procedure: Postoperative transverse abdominal plain (TAP) blockade

Study type: Interventional

Funder types: Other

Identifiers

NCT01501565

2011-003219-53 (EudraCT Number)

FP2011/01

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Control

No Intervention group

Description:

Standard analgesic therapy: iv Metamizol 2 g q8h

TAP

Experimental group

Description:

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.

Treatment:

Procedure: Postoperative transverse abdominal plain (TAP) blockade