Clinical trial NCT03181438: Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery
Official title: Efficacy of Ultrasound-guided Transverse Abdominal Plane Block for Analgesia in Renal Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency, Chronic
Acute Pain
Kidney Transplantation
Anesthesia, Conduction
Keywords: Renal Transplantation
Acute pain
Regional Anesthesia
TAP Block
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Morphine Consumption
timeFrame: 24 hours post-operative
Secondary outcomes:
measure: Pain Score
timeFrame: 24 hours post-operative
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensao
Study officials:
affiliation: Federal University of São Paulo
name: Leonardo HC Ferraro, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dean M. Opioids in renal failure and dialysis patients. J Pain Symptom Manage. 2004 Nov;28(5):497-504. doi: 10.1016/j.jpainsymman.2004.02.021.
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.
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. doi: 10.1016/j.rapm.2007.03.011.
citation: Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
citation: Warman P, Nicholls B. Ultrasound-guided nerve blocks: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):313-26. doi: 10.1016/j.bpa.2009.02.004.
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 Jun 26.
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. No abstract available.