Skip to main content
OpenTrials
Completed

NCT Number: NCT02287623

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • presenting for donor nephrectomy

Exclusion criteria

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

Treatment and study plan

Liposomal bupivacaine

Drug

patients will receive a tap with liposomal bupivacaine

Bupivacaine

Drug

patients will receive a tap with bupivacaine

Primary outcomes

  1. 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

  1. Post Operative Opioid Use

    Time frame: 48-72 hours

  2. Number of Patients With Post Operative Nausea/Vomiting

    Time frame: 0-72 hours

  3. Post Operative Length of Stay

    Time frame: up to 30 days after surgery

  4. Postoperative Opioid Use

    Time frame: 24-48 hours

    Use of opioids during 24-48 hours after surgery

  5. Post Operative Opioid Use

    Time frame: 0-24 hours

    Post operative opioid use from 0-24 hours after surgery.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2014
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.