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

Phase 4

Completed

• Conditions: Acute Pain
• Interventions: Drug: liposomal bupivacaine; Drug: bupivacaine

• Registration Number: NCT02287623
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-07
• Study Completion: 2014-10
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-11
• Results First Submitted: 2015-08-10
• Results First Submitted QC: 2015-10-12
• Results First Posted: 2015-11-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• presenting for donor nephrectomy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liposomal bupivacaine TAP	liposomal bupivacaine	Patients will receive a TAP block with liposomal bupivacaine
bupivacaine TAP	bupivacaine	Patients will receive a TAP block with bupivacaine

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale	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 Outcome Measures

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