Transversus Abdominis Plane (TAP) Block After Kidney Transplantation
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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 |
- 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.
- 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.
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | December 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 |
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| United States, California | |
| UCSF Medical Center at Parnassus | Not yet recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Matthias R Braehler, MD 415-502-2152 braehlerm@anesthesia.ucsf.edu | |
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: | December 24, 2011 |
| 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 May 22, 2013