Transversus Abdominis Plane (TAP) Block After Kidney Transplantation

Not Applicable

Withdrawn

• Conditions: Transplantation, Kidney
• Interventions: Procedure: Transversus abdominis plane (TAP) block; Procedure: Sham TAP block with normal saline

• Registration Number: NCT01496729
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-21
• Study Start: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2013-01
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus abdominis plane (TAP) block with ropivacaine	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 TAP block with normal saline	Sham TAP block with normal saline	A sham TAP block with normal saline will be performed at the end of the surgical procedure.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

UCSF Medical Center at Parnassus; 🇺🇸 San Francisco, California, United States