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Liposomal Bupivacaine vs Peripheral Nerve Block

Primary Purpose

Pain, Acute, Surgery, Anesthesia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Peripheral Nerve Block
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients 18 years of age or older
  2. Patients undergoing elective primary ankle or hindfoot surgery (ankle arthrodesis, subtalar arthrodesis, triple arthrodesis, total ankle arthroplasty, peroneal tendon debridement/transfer, Cavus Reconstruction, Medial Displacement Calcaneal Osteotomy, Dwyer Osteotomy)

Exclusion Criteria:

  1. Patients who are undergoing revision surgical procedure
  2. Patients who have taken opioid pain medications in the past 3 months prior to surgical procedure
  3. Patients who have allergies to any of the medications or components of medications investigated in the study
  4. Patients currently incarcerated
  5. Patients who cannot read and speak English

Sites / Locations

  • Geisinger Woodbine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal Bupivacaine Group

Peripheral Nerve Block Group

Arm Description

No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area.

Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration

Outcomes

Primary Outcome Measures

Visual Analog Scale Pain Score
Best 0-10 worst - Continuous scale to measure current pain level

Secondary Outcome Measures

Morphine Equivalents
morphine equivalents consumed for post-operative pain control
Investigator-developed, Pain Satisfaction Score
asks patients to rate their level of satisfaction with their pain control on a scale of 0-10, 0 being not satisfied at all and 10 being highly satisfied
Range of Motion
range of motion measured using goniometer
Number of Participants With Complications
complications after surgery including infection and delayed healing
Number of Participants With Unscheduled Healthcare Contact
unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits

Full Information

First Posted
April 17, 2019
Last Updated
January 27, 2023
Sponsor
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03922620
Brief Title
Liposomal Bupivacaine vs Peripheral Nerve Block
Official Title
Liposomal Bupivacaine vs Peripheral Nerve Block
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Additional published information on the topic since starting the study
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients.
Detailed Description
Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. Liposomal bupivacaine is an analgesic that is suspended in lipids to allow for gradual release of the analgesic over a 72-hour period (NAMDARI). From prior literature, the utilization of local analgesics infiltrated into surgical sites have been shown to reduce pain in the immediate post-operative period in foot and ankle surgery (GADEK). However, the evaluation of liposomal bupivacaine in foot and ankle surgery is limited. One prospective study found that the addition to liposomal bupivacaine to a multi-modal pain management protocol for forefoot surgery resulted in decreased pain scores during the first four post-operative days as well as fewer refills of opioid pain medication prescriptions, although both findings were not statically significant (ROBBINS). As the general medical community and public policy makers continue to focus on decreasing the amount of opioid pain medications prescribed and available in the community due to the opioid epidemic, liposomal bupivacaine has the potential to be a useful adjunct in the management of post-operative pain without reliance on opioid prescriptions. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients. Furthermore, this study aims to determine if there are differences in the amount of opioid medications utilized for post-operative pain control, patient satisfaction scores, functional outcomes, complications, and unscheduled healthcare contact between the two groups. In order to accomplish these aims, a randomized, controlled investigation will be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Surgery, Anesthesia, Opioid Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivacaine Group
Arm Type
Experimental
Arm Description
No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area.
Arm Title
Peripheral Nerve Block Group
Arm Type
Active Comparator
Arm Description
Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area
Intervention Type
Drug
Intervention Name(s)
Peripheral Nerve Block
Intervention Description
Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Primary Outcome Measure Information:
Title
Visual Analog Scale Pain Score
Description
Best 0-10 worst - Continuous scale to measure current pain level
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Morphine Equivalents
Description
morphine equivalents consumed for post-operative pain control
Time Frame
0-6 weeks
Title
Investigator-developed, Pain Satisfaction Score
Description
asks patients to rate their level of satisfaction with their pain control on a scale of 0-10, 0 being not satisfied at all and 10 being highly satisfied
Time Frame
0-6 weeks
Title
Range of Motion
Description
range of motion measured using goniometer
Time Frame
0-6 weeks
Title
Number of Participants With Complications
Description
complications after surgery including infection and delayed healing
Time Frame
6 weeks
Title
Number of Participants With Unscheduled Healthcare Contact
Description
unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older Patients undergoing elective primary ankle or hindfoot surgery (ankle arthrodesis, subtalar arthrodesis, triple arthrodesis, total ankle arthroplasty, peroneal tendon debridement/transfer, Cavus Reconstruction, Medial Displacement Calcaneal Osteotomy, Dwyer Osteotomy) Exclusion Criteria: Patients who are undergoing revision surgical procedure Patients who have taken opioid pain medications in the past 3 months prior to surgical procedure Patients who have allergies to any of the medications or components of medications investigated in the study Patients currently incarcerated Patients who cannot read and speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Cush, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Woodbine
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States

12. IPD Sharing Statement

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Liposomal Bupivacaine vs Peripheral Nerve Block

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