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This study has been withdrawn prior to enrollment.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

December 19, 2011
October 8, 2013
January 2012
January 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01496729 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Transversus Abdominis Plane (TAP) Block After Kidney Transplantation
Single Shot Transversus Abdominis Plane (TAP) Block Versus Sham Block for Analgesia in Donors and Recipients Following Kidney Transplantation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Transplantation, Kidney
  • 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.
  • Procedure: Sham TAP block with normal saline
    A sham TAP block with normal saline will be performed at the end of the surgical procedure.
  • 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
    Intervention: Procedure: Transversus abdominis plane (TAP) block
  • 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.
    Intervention: Procedure: Sham TAP block with normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2013
January 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01496729
11-06622
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Not Provided
University of California, San Francisco
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP