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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: liposomal bupivacaine
* Drug: bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presenting for donor nephrectomy Exclusion Criteria: non english speaking chronic pain condition taking chronic opioids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: liposomal bupivacaine TAP<br>Patients will receive a TAP block with liposomal bupivacaine | Drug: liposomal bupivacaine<br>* patients will receive a tap with liposomal bupivacaine<br>|
| Active Comparator: bupivacaine TAP<br>Patients will receive a TAP block with bupivacaine | Drug: bupivacaine<br>* patients will receive a tap with bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | 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. | 48-72 hours after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Opioid Use |  | 48-72 hours | 
| Number of Patients With Post Operative Nausea/Vomiting |  | 0-72 hours | 
| Post Operative Length of Stay |  | up to 30 days after surgery | 
| Postoperative Opioid Use | Use of opioids during 24-48 hours after surgery | 24-48 hours | 
| Post Operative Opioid Use | Post operative opioid use from 0-24 hours after surgery. | 0-24 hours |