Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

Not Applicable

• Conditions: Kidney Transplantation; Renal Insufficiency, Chronic; Anesthesia, Conduction; Acute Pain
• Interventions: Procedure: TAP Block; Procedure: Saline Group

• 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

Arm && Interventions

Group	Intervention	Description
TAP Block	TAP Block	The TAP block will be performed under general anesthesia, according to the technique described below: * The patient will be placed supine with the abdomen exposed between the iliac crest and the costal margin * After skin antisepsis, a high-frequency ultrasound transducer will be placed transversely across the anterior axillary line above the iliac crest * In this region, the abdominal musculature (external oblique, internal oblique and transverse abdomen) is identified, and the transverse abdominal plane of the abdomen * The needle (BD-A-50mm) will be inserted in the technique "in plane" to the region of the transverse plane of the abdomen, where the solution will be administered. * In this group, will be administered 20 mL of 0.375% ropivacaine
Saline Group	Saline Group	The block will be performed under general anesthesia, according to the technique described below: * The patient will be placed supine with the abdomen exposed between the iliac crest and the costal margin * After skin antisepsis, a high-frequency ultrasound transducer will be placed transversely across the anterior axillary line above the iliac crest * In this region, the abdominal musculature (external oblique, internal oblique and transverse abdomen) is identified, and the transverse abdominal plane of the abdomen * The needle (BD-A-50mm) will be inserted in the technique "in plane" to the region of the transverse plane of the abdomen, where the solution will be administered. * In this group, will be administered 20 mL of Saline

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