NCT05992896

Brief Summary

The purpose of this research is to find out if using liposomal bupivacaine solution (bupivacaine liposome) injections during lower extremity revascularization surgery will lower the amount of narcotic drugs used during and following the procedure.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 26, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 29, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

August 7, 2023

Results QC Date

April 6, 2026

Last Update Submit

May 4, 2026

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial diseasepostoperative pain controlnarcotic abuseIlio-inguinal blockregional anesthesia

Outcome Measures

Primary Outcomes (5)

  • Postoperative Use of Narcotics at 12 Hours

    The amount of narcotics used postoperatively 12 hours after injection, measured in morphine equivalent.

    12 hours after injection

  • Postoperative Use of Narcotics at 24 Hours

    The amount of narcotics used postoperatively 24 hours after injection, measured in morphine equivalent.

    24 hours after injection

  • Postoperative Use of Narcotics at 48 Hours

    The amount of narcotics used postoperatively 48 hours after injection, measured in morphine equivalent.

    48 hours after injection

  • Postoperative Use of Narcotics at 72 Hours

    The amount of narcotics used postoperatively 72 hours after injection, measured in morphine equivalent.

    72 hours after injection

  • Postoperative Use of Narcotics at 30 Days

    The amount of narcotics used postoperatively 30 days after injection, measured in morphine equivalent.

    30 days after injection

Secondary Outcomes (4)

  • Postoperative Quality of Recovery at 14 Days

    14 days after injection

  • Postoperative Quality of Recovery at 28 Days

    28 days after injection

  • Intraoperative Use of Narcotics

    During surgery approximately 2 to 6 hours

  • Hospital Length of Stay

    28 days

Study Arms (2)

Liposomal Bupivacaine Group

EXPERIMENTAL

Subjects will receive an injection of liposomal bupivacaine during clinically indicated lower extremity revascularization surgery.

Drug: Bupivacaine liposome

Placebo Group

PLACEBO COMPARATOR

Subjects will receive an injection of placebo during clinically indicated lower extremity revascularization surgery.

Drug: Placebo

Interventions

Bupivacaine liposomeDRUG

Injection into pelvic area and into the edges of wound at the end of the procedure.

Liposomal Bupivacaine Group
PlaceboDRUG

Looks exactly like the study drug, but contains no active ingredients. Injection into pelvic area and into the edges of wound at the end of the procedure .

Placebo Group

Eligibility Criteria

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

You may qualify if:

  • \- Those who present for elective lower extremity revascularization.

You may not qualify if:

  • Non-English speaking.
  • Chronic pain.
  • On opioids greater than 1 weeks.
  • Allergy to local anesthetics.
  • Use of spinal or epidural for surgery.
  • Lack of patient cooperation.
  • Contraindication to regional anesthesia.
  • Vulnerable individuals.
  • Urgent/emergent surgeries
  • Known to be pregnant or able to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Health System - Eau Claire

Eau Claire, Wisconsin, 54703, United States

Location

Related Links

MeSH Terms

Conditions

Peripheral Arterial DiseaseNarcotic-Related Disorders

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Limitations and Caveats

This study was terminated early due to a lack of funding.

Results Point of Contact

Title
Tiziano Tallarita,M.D.
Organization
Mayo Clinic
tallarita.tiziano@mayo.edu
715-464-8173

Study Officials

  • Tiziano Tallarita, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

September 26, 2023

Primary Completion

May 15, 2025

Study Completion

June 30, 2025

Last Updated

May 29, 2026

Results First Posted

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)