Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

TAP Block

Saline Group

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Renal Transplantation, Acute pain, Regional Anesthesia, TAP Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital do Rim e HipertensaoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TAP Block

Saline Group

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain Score

Visual analogue score (VAS) at rest and movement

Full Information

NCT ID

NCT03181438

First Posted

June 3, 2017

Last Updated

June 7, 2017

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03181438

Brief Title

Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 3, 2017 (Actual)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Renal Transplantation, Acute pain, Regional Anesthesia, TAP Block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TAP Block

Arm Type

Experimental

Arm 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

Arm Title

Saline Group

Arm Type

Sham Comparator

Arm 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

Intervention Type

Procedure

Intervention Name(s)

TAP Block

Intervention Description

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

Intervention Name(s)

Saline Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Morphine Consumption

Description

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.

Time Frame

24 hours post-operative

Secondary Outcome Measure Information:

Title

Pain Score

Description

Visual analogue score (VAS) at rest and movement

Time Frame

24 hours post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leonardo HC Ferraro, Professor

Phone

+ 55 11 999516103

Email

leohcferraro1@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonardo HC Ferraro, Professor

Organizational Affiliation

Federal University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital do Rim e Hipertensao

City

Sao Paulo

ZIP/Postal Code

04038-002

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leonardo HC Ferraro, Professor

Phone

+ 55 11 99951-6103

Email

leohcferraro1@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

21704871

Citation

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.

Results Reference

result

PubMed Identifier

15504625

Citation

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.

Results Reference

result

PubMed Identifier

20377549

Citation

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.

Results Reference

result

PubMed Identifier

17961838

Citation

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.

Results Reference

result

PubMed Identifier

11576144

Citation

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.

Results Reference

result

PubMed Identifier

19862890

Citation

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.

Results Reference

result

PubMed Identifier

19561014

Citation

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.

Results Reference

result

PubMed Identifier

20400617

Citation

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.

Results Reference

result

Renal Insufficiency, Chronic, Acute Pain, Kidney Transplantation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial