ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03181438
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Leonardo Henrique Cunha Ferraro, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Acute Pain Kidney Transplantation Anesthesia, Conduction Procedure: TAP Block Procedure: Saline Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Ultrasound-guided Transverse Abdominal Plane Block for Analgesia in Renal Transplantation
Actual Study Start Date : June 3, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAP Block

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
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

Sham Comparator: Saline Group

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




Primary Outcome Measures :
  1. Morphine Consumption [ Time Frame: 24 hours post-operative ]
    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.


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: 24 hours post-operative ]
    Visual analogue score (VAS) at rest and movement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181438


Contacts
Contact: Leonardo HC Ferraro, Professor + 55 11 999516103 leohcferraro1@hotmail.com

Locations
Brazil
Hospital do Rim e Hipertensao Recruiting
Sao Paulo, Brazil, 04038-002
Contact: Leonardo HC Ferraro, Professor    + 55 11 99951-6103    leohcferraro1@hotmail.com   
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Leonardo HC Ferraro, Professor Federal University of Sao Paulo

Publications of Results:
Responsible Party: Leonardo Henrique Cunha Ferraro, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03181438     History of Changes
Other Study ID Numbers: TAP Block Renal Transplant
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leonardo Henrique Cunha Ferraro, Federal University of São Paulo:
Renal Transplantation
Acute pain
Regional Anesthesia
TAP Block

Additional relevant MeSH terms:
Renal Insufficiency
Acute Pain
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms