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

Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Postoperative transverse abdominal plain (TAP) blockade

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Fundacio Puigvert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard analgesic therapy: iv Metamizol 2 g q8h
Experimental: TAP; 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 Names: Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fundacio Puigvert
• Investigators: Principal Investigator: Juan Francisco Mayoral, MD, Fundació Puigvert (IUNA)

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 27, 2011
• First Posted (Estimate): December 29, 2011

Study Record Updates

• Last Update Posted (Estimate): November 16, 2012
• Last Update Submitted That Met QC Criteria: November 15, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Postoperative pain; Urology; Transverse abdominal blockade
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: FP2011/01; 2011-003219-53 (EudraCT Number)