Back to results

Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial

Primary Purpose

Pain, Postoperative, Pain, Acute Postoperative, Ankle Fractures

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Exparel

Peripheral Nerve Block

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring liposomal bupivacaine, ankle surgery, postoperative pain, regional nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution
English speaking
Able to provide consent to surgery and study participation

Exclusion Criteria:

Non-elective or emergent foot and ankle surgery
Non-english speaking
Does not possess medical decision making capacity

Sites / Locations

St. Luke's University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Peripheral Nerve Block Without Exparel

Peripheral Nerve Block with Exparel

Local Infiltration of Exparel

Arm Description

Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine

Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine

Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine

Outcomes

Primary Outcome Measures

Duration of block

Secondary Outcome Measures

number of opioid pills used by postoperative day # 4

PROMIS Scores

oral morphine equivalent use by postoperative day 4

Full Information

NCT ID

NCT05494645

First Posted

August 8, 2022

Last Updated

August 8, 2022

Sponsor

St. Luke's Hospital, Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT05494645

Brief Title

Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial

Official Title

Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

June 1, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Luke's Hospital, Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.

Detailed Description

three study groups: A - surgeon infiltrates with exparel on site of surgery; B - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); C - anesthesia provides a regional nerve block (popliteal/adductor) with Exparel/bupivacaine mix. Follow up occurs on postop day 4 via phone call to patient. Measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Pain, Acute Postoperative, Ankle Fractures, Ankle Injuries and Disorders

Keywords

liposomal bupivacaine, ankle surgery, postoperative pain, regional nerve block

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Masking

Participant

Masking Description

patient is blinded to study

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Peripheral Nerve Block Without Exparel

Arm Type

Active Comparator

Arm Description

Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine

Arm Title

Peripheral Nerve Block with Exparel

Arm Type

Experimental

Arm Description

Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine

Arm Title

Local Infiltration of Exparel

Arm Type

Experimental

Arm Description

Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine

Intervention Type

Drug

Intervention Name(s)

Exparel

Other Intervention Name(s)

Liposomal bupivicaine

Intervention Description

Liposomal bupivicaine

Intervention Type

Drug

Intervention Name(s)

Peripheral Nerve Block

Other Intervention Name(s)

marcaine, bupivicaine

Intervention Description

Peripheral nerve block without Exparel

Primary Outcome Measure Information:

Title

Duration of block

Time Frame

3 Months

Secondary Outcome Measure Information:

Title

number of opioid pills used by postoperative day # 4

Time Frame

3 months

Title

PROMIS Scores

Time Frame

3 months

Title

oral morphine equivalent use by postoperative day 4

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution English speaking Able to provide consent to surgery and study participation Exclusion Criteria: Non-elective or emergent foot and ankle surgery Non-english speaking Does not possess medical decision making capacity

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Ng-Pellegrino

Phone

610-954-4000

anna.ngpellegrino@sluhn.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Ng-Pellegrino

Organizational Affiliation

St. Luke's Hospital and Health Network, Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Luke's University Health Network

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brendan Smith, MD

Phone

484-526-8290

Brendan.smith@sluhn.org

First Name & Middle Initial & Last Name & Degree

Brendan Smith, MD

First Name & Middle Initial & Last Name & Degree

Ajith Malige, MD

First Name & Middle Initial & Last Name & Degree

James Lachman, MD

First Name & Middle Initial & Last Name & Degree

Anna Ng Pellegrino, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial

We'll reach out to this number within 24 hrs