Transversus Abdominis Plane (TAP) Block After Kidney Transplantation

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01496729
First received: December 19, 2011
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

Postoperative pain is a major problem in patients who either donate a kidney or undergo kidney transplantation. This pain is commonly treated with opioids, which can cause several side effects, ranging from pruritus, impaired vigilance, and most concerning to severe respiratory depression. This can be aggravated in the recipient by accumulation of opioid metabolites secondary to renal impairment and secretion.

Several studies have shown an opioid sparing effect of a transversus abdominis plane (TAP) block after surgery in the lower abdomen. In the proposed study, we plan to compare the impact of an ultrasound guided single shot transversus abdominis plane (TAP) block versus a ultrasound guided sham block with normal saline (placebo) on postoperative pain scores, postoperative opioid consumption, as well as patient's satisfaction.

The investigators hypothesize, that patients who receive a TAP block will have lower postoperative pain scores, lower postoperative opioid consumption as well as higher satisfaction scores.


Condition Intervention
Transplantation, Kidney
Procedure: Transversus abdominis plane (TAP) block
Procedure: Sham TAP block with normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Shot Transversus Abdominis Plane (TAP) Block Versus Sham Block for Analgesia in Donors and Recipients Following Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Pain after kidney transplantation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain scores after kidney transplantation are measured with the visual analog scale (VAS) several times at defined times after kidney transplantation during the first 24 hours after surgery. Pain scores between the two arms of the study will be compared to each other.


Secondary Outcome Measures:
  • Use of opioids after kidney transplantation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The total amount of opioids needed in the first 24 hours after kidney transplantation is recorded with the help of a patient controlled analgesia (PCA) pump and compared between the two arms of the study.


Enrollment: 0
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transversus abdominis plane (TAP) block with ropivacaine
A Transversus abdominis plane (TAP) block with ropivacaine, a local anesthetic, will be performed at the end of the surgical procedure
Procedure: Transversus abdominis plane (TAP) block
A Transversus abdominis plane (TAP) block with ropivacaine, a local anesthetic, will be performed at the end of the surgical procedure.
Sham Comparator: Sham TAP block with normal saline
A sham TAP block with normal saline will be performed at the end of the surgical procedure.
Procedure: Sham TAP block with normal saline
A sham TAP block with normal saline will be performed at the end of the surgical procedure.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years, English speaking, receiving a kidney transplant or donating a kidney as part of standard clinical care

Exclusion Criteria:

  • Allergy to local anesthetics or opioids, coagulopathy or dementia. Patients with known history of IV drug abuse and with very high preoperative opioid requirements (defined as > 120 mg oxycodone/ day, use of methadone or fentanyl patches) will also be excluded from this study.

Coagulopathy will be assessed by the patient's history and physical. Should there be concerns regarding "easy bleeding" or "easy bruising", further workup of the patient's coagulation will be ordered (PT, PTT, INR). Since we perform the TAP block after 3-4 hours of kidney surgery, any patient with coagulopathy will most likely have been canceled prior to surgery. Therefore, we would deem any patient, who was eligible for kidney surgery, eligible for a TAP block at the end of the surgical procedure.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496729

Locations
United States, California
UCSF Medical Center at Parnassus
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01496729     History of Changes
Other Study ID Numbers: 11-06622
Study First Received: December 19, 2011
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Kidney transplantation
Transversus abdominis plane (TAP) block

Additional relevant MeSH terms:
Anesthetics, Local
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014