Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: TAP Block
* Procedure: Saline Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP Block<br>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<br>* 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<br>|
| Sham Comparator: Saline Group<br>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<br>* t will be performed a ultrasound-guided transverse abdominal plane block with 2o mL of saline for patients submitted to renal transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Visual analogue score (VAS) at rest and movement | 24 hours post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Transplantation, Acute pain, Regional Anesthesia, TAP Block