Transversus Abdominis Plane (TAP) Block After Kidney Transplantation

Sponsor
University of California, San Francisco (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01496729
Collaborator
(none)
0
1
2
12
0

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Transversus abdominis plane (TAP) block
  • Procedure: Sham TAP block with normal saline
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Pain after kidney transplantation [24 hours]

    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

  1. Use of opioids after kidney transplantation [24 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 UCSF Medical Center at Parnassus San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01496729
Other Study ID Numbers:
  • 11-06622
First Posted:
Dec 21, 2011
Last Update Posted:
Oct 10, 2013
Last Verified:
Oct 1, 2013
Keywords provided by University of California, San Francisco

Study Results

No Results Posted as of Oct 10, 2013