Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

NCT03181438 | Unknown

• 1 other identifier: TAP Block Renal Transplant
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Renal Transplantation; Acute pain; Regional Anesthesia; TAP Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Score

  24 hours post-operative

Study Arms (2)

TAP Block

EXPERIMENTAL

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

Procedure: TAP Block

Saline Group

SHAM COMPARATOR

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

Procedure: Saline Group

Interventions

TAP Block PROCEDURE

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

TAP Block

Saline Group PROCEDURE

t will be performed a ultrasound-guided transverse abdominal plane block with 2o mL of saline for patients submitted to renal transplantation

Saline Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• end-stage renal disease undergoing cadaveric renal transplantation

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital do Rim e Hipertensao

São Paulo, 04038-002, Brazil

RECRUITING

Related Publications (8)

• 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.

  PMID: 21704871 RESULT

• 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.

  PMID: 15504625 RESULT

• 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.

  PMID: 20377549 RESULT

• 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.

  PMID: 17961838 RESULT

• 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.

  PMID: 11576144 RESULT

• 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.

  PMID: 19862890 RESULT

• 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.

  PMID: 19561014 RESULT

• 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.

  PMID: 20400617 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Pain

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Leonardo HC Ferraro, Professor

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo HC Ferraro, Professor

CONTACT

+ 55 11 999516103; leohcferraro1@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 8, 2017
• Study Start: June 3, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)