Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03181438
• Other study ID #: TAP Block Renal Transplant
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2017
• Last updated: June 7, 2017
• Start date: June 3, 2017
• Est. completion date: September 2017

Study information

• Verified date: June 2017
• Source: Federal University of São Paulo
• Contact: Leonardo HC Ferraro, Professor
• Phone: + 55 11 999516103
• Email: leohcferraro1[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia, Conduction
• Kidney Transplantation
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Procedure:
• TAP Block
It will be performed a ultrasound-guided transverse abdominal plane block with 20 ml of 0.375% of ropivacaine for patients submitted to renal transplantation
• Saline Group
t will be performed a ultrasound-guided transverse abdominal plane block with 2o mL of saline for patients submitted to renal transplantation

Locations

Country	Name	City	State
Brazil	Hospital do Rim e Hipertensao	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Dean M. Opioids in renal failure and dialysis patients. J Pain Symptom Manage. 2004 Nov;28(5):497-504. Review. — View Citation

Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x. Review. — View Citation

McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. — View Citation

Mukhtar K, Khattak I. Transversus abdominis plane block for renal transplant recipients. Br J Anaesth. 2010 May;104(5):663-4. doi: 10.1093/bja/aeq077. — View Citation

Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 — View Citation

Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. — View Citation

Warman P, Nicholls B. Ultrasound-guided nerve blocks: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):313-26. Review. — View Citation

Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011 Jun 25;377(9784):2215-25. doi: 10.1016/S0140-6736(11)60245-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Consumption	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.	24 hours post-operative
Secondary	Pain Score	Visual analogue score (VAS) at rest and movement	24 hours post-operative