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Clinical Trials/NCT03181438
NCT03181438
Unknown
Not Applicable

Efficacy of Ultrasound-guided Transverse Abdominal Plane Block for Analgesia in Renal Transplantation

Federal University of São Paulo1 site in 1 country42 target enrollmentJune 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Insufficiency, Chronic
Sponsor
Federal University of São Paulo
Enrollment
42
Locations
1
Primary Endpoint
Morphine Consumption
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 3, 2017
End Date
September 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Leonardo Henrique Cunha Ferraro

Professor

Federal University of São Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Morphine Consumption

Time Frame: 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 Outcomes

  • Pain Score(24 hours post-operative)

Study Sites (1)

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