Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study
Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pain
Intervention: liposomal bupivacaine (Drug); bupivacaine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Minnesota - Clinical and Translational Science Institute
Summary
The primary objective of this study is whether one local anesthetic, liposomal bupivacaine,
provides improved pain control and decreased opioid use compared to bupivacaine when
injected during a transversus abdominis plane block for donor nephrectomy patients.
Clinical Details
Official title: Subcostal TAP Block With Liposomal Bupivacaine vs Bupivacaine in Donor Nephrectomy Patients: A Prospective Randomized Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Post operative pain control
Secondary outcome: post operative opioid usepost operative nausea/vomiting post operative length of stay
Detailed description:
The primary objective of this study is whether one local anesthetic, liposomal bupivacaine,
provides improved pain control and decreased opioid use compared to bupivacaine when
injected during a transversus abdominis plane block for donor nephrectomy patients.
Background and treatment procedure: Liposomal bupivacaine is a multi vesicular formulation
of bupivacaine that has been shown to provide up to 72 hours of analgesia compared to
bupivacaine which provides up to 24 hours of analgesia post injection. These two
medications have been compared using a infiltration or injection at the site of incision but
have yet to be compared when used during a TAP block. A TAP block is an injection of local
anesthetic under the covering of the transversus abdominis muscle layer. This layer is
found using an ultrasound which is a beam of high frequency sound that allows one to
visualize images in the body. Then using this ultrasound we can see our needle as it
pierces the covering of the transversus abdominis muscle layer and watch as the local
anesthetic is injected into this plane. This is done on both sides of the abdomen to
provide analgesia to the skin, muscle, and fascial layers of the abdomen.
Population: Adult patients who are undergoing a donor nephrectomy Rationale: It will be
useful to determine if one formulation or the other provides better and longer lasting pain
control for patients undergoing abdominal procedures.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- presenting for donor nephrectomy
Exclusion Criteria:
- non english speaking
- chronic pain condition
- taking chronic opioids
Locations and Contacts
Additional Information
Starting date: May 2013
Last updated: March 25, 2015
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