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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
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Started Jan 2012
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedOctober 10, 2013
October 1, 2013
Same day
December 19, 2011
October 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain after kidney transplantation
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.
24 hours
Secondary Outcomes (1)
Use of opioids after kidney transplantation
24 hours
Study Arms (2)
Transversus abdominis plane (TAP) block with ropivacaine
ACTIVE COMPARATORA 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 COMPARATORA sham TAP block with normal saline will be performed at the end of the surgical procedure.
Interventions
A Transversus abdominis plane (TAP) block with ropivacaine, a local anesthetic, will be performed at the end of the surgical procedure.
A sham TAP block with normal saline will be performed at the end of the surgical procedure.
Eligibility Criteria
You may qualify if:
- Age \> 18 years, English speaking, receiving a kidney transplant or donating a kidney as part of standard clinical care
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Medical Center at Parnassus
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2011
First Posted
December 21, 2011
Study Start
January 1, 2012
Primary Completion
January 1, 2012
Study Completion
January 1, 2013
Last Updated
October 10, 2013
Record last verified: 2013-10