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Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

F

Federal University of São Paulo

Status

Unknown

Conditions

Anesthesia, Conduction
Kidney Transplantation
Acute Pain
Renal Insufficiency, Chronic

Treatments

Procedure: TAP Block
Procedure: Saline Group

Study type

Interventional

Funder types

Other

Identifiers

NCT03181438
TAP Block Renal Transplant

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

42 participants in 2 patient groups

TAP Block
Experimental group
Description:
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
Treatment:
Procedure: TAP Block
Saline Group
Sham Comparator group
Description:
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
Treatment:
Procedure: Saline Group

Trial contacts and locations

1

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Central trial contact

Leonardo HC Ferraro, Professor

Data sourced from clinicaltrials.gov

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