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Clinical Trials/NCT02287623
NCT02287623
Completed
Phase 4

Subcostal TAP Block With Liposomal Bupivacaine vs Bupivacaine in Donor Nephrectomy Patients: A Prospective Randomized Study

University of Minnesota0 sites60 target enrollmentMay 2013

Overview

Phase
Phase 4
Intervention
liposomal bupivacaine
Conditions
Acute Pain
Sponsor
University of Minnesota
Enrollment
60
Primary Endpoint
Numerical Rating Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
October 2014
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • presenting for donor nephrectomy

Exclusion Criteria

  • non english speaking
  • chronic pain condition
  • taking chronic opioids

Arms & Interventions

liposomal bupivacaine TAP

Patients will receive a TAP block with liposomal bupivacaine

Intervention: liposomal bupivacaine

bupivacaine TAP

Patients will receive a TAP block with bupivacaine

Intervention: bupivacaine

Outcomes

Primary Outcomes

Numerical Rating Scale

Time Frame: 48-72 hours after injection

This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.

Secondary Outcomes

  • Post Operative Length of Stay(up to 30 days after surgery)
  • Post Operative Opioid Use(0-24 hours)
  • Postoperative Opioid Use(24-48 hours)
  • Number of Patients With Post Operative Nausea/Vomiting(0-72 hours)

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