NCT02287623

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 11, 2015

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

October 30, 2014

Results QC Date

August 10, 2015

Last Update Submit

April 6, 2023

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    24-48 hours

  • Post Operative Opioid Use

    0-24 hours

Study Arms (2)

liposomal bupivacaine TAP

EXPERIMENTAL

Patients will receive a TAP block with liposomal bupivacaine

Drug: liposomal bupivacaine

bupivacaine TAP

ACTIVE COMPARATOR

Patients will receive a TAP block with bupivacaine

Drug: bupivacaine

Interventions

liposomal bupivacaineDRUG

patients will receive a tap with liposomal bupivacaine

liposomal bupivacaine TAP
bupivacaineDRUG

patients will receive a tap with bupivacaine

bupivacaine TAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presenting for donor nephrectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Jacob Hutchins
Organization
University of Minnesota
hutc0079@umn.edu
612-624-9990

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 11, 2014

Study Start

May 1, 2013

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

April 10, 2023

Results First Posted

November 11, 2015

Record last verified: 2023-04