Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

NCT ID: NCT03181438

Last Updated: 2017-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-03

Study Completion Date

2017-09-30

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.

Detailed Description

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Conditions

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Renal Insufficiency, Chronic Acute Pain Kidney Transplantation Anesthesia, Conduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

TAP Block

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Saline Group

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Leonardo Henrique Cunha Ferraro

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonardo HC Ferraro, Professor

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Hospital do Rim e Hipertensao

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Leonardo HC Ferraro, Professor

Role: CONTACT

+ 55 11 999516103

Facility Contacts

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Leonardo HC Ferraro, Professor

Role: primary

+ 55 11 99951-6103

References

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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.

Reference Type RESULT
PMID: 21704871 (View on PubMed)

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.

Reference Type RESULT
PMID: 15504625 (View on PubMed)

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.

Reference Type RESULT
PMID: 20377549 (View on PubMed)

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.

Reference Type RESULT
PMID: 17961838 (View on PubMed)

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.

Reference Type RESULT
PMID: 11576144 (View on PubMed)

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.

Reference Type RESULT
PMID: 19862890 (View on PubMed)

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.

Reference Type RESULT
PMID: 19561014 (View on PubMed)

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.

Reference Type RESULT
PMID: 20400617 (View on PubMed)

Other Identifiers

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TAP Block Renal Transplant

Identifier Type: -

Identifier Source: org_study_id

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