Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

Not Applicable

• Conditions: Kidney Transplantation; Renal Insufficiency, Chronic; Anesthesia, Conduction; Acute Pain

• Registration Number: NCT03181438
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The objective of this study is to evaluate the efficacy and safety of transverse abdominal plane block in patients undergoing renal transplant surgery.Adult renal transplant recipients will be prospectively randomized to receive a standard general anesthetic technique supplemented with ropivacaine 0.375% 20 mL TAP block or sham block with 20 mL 0.9% saline. Both groups will receive patient-controlled morphine analgesia. Patient assessment will occur in the postanesthetic care unit and at 1, 2, 4, 6, 12, and 24 hours. The primary outcome is total morphine consumption in the first 24 hours after renal transplantation. Other outcomes asses include pain scores, presence of nausea or vomiting, excessive sedation, and respiratory depression.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study Start: 2017-06-03
• Study First Submitted: 2017-06-03
• Study First Submitted QC: 2017-06-07
• Last Update Submitted: 2017-06-07
• Study First Posted: 2017-06-08
• Last Update Posted: 2017-06-08
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• end-stage renal disease undergoing cadaveric renal transplantation

Exclusion Criteria

• Contraindications to the use of morphine
• Contraindications to the use ropivacaine
• Peripheral neuropathy
• Inability to use a Patient Control Analgesia device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morphine Consumption	24 hours post-operative	Patient Control Analgesia: morphine sulfate 2 mg IV every 5 minutes until visual analog scale pain score (0 = no pain, 10 = worst possible pain) is 3 or less, and continued at the following settings for a 24-hour period: 1 mg bolus, 7-minute lockout, and 30 mg maximum 4-hourly dose.

Secondary Outcome Measures

Name	Time	Method
Pain Score	24 hours post-operative	Visual analogue score (VAS) at rest and movement

Trial Locations

Locations (1)

Hospital do Rim e Hipertensao; 🇧🇷 Sao Paulo, Brazil