NCT02499575

Brief Summary

Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

July 2, 2015

Results QC Date

November 30, 2016

Last Update Submit

April 14, 2017

Conditions

BunionHallux Rigidus

Keywords

ExparelbupivacaineHallux valgus deformitybunionectomy

Outcome Measures

Primary Outcomes (2)

  • Opioid Use as Measured by Questionnaire

    Compare time to first opioid use over 72 hours between groups

    Daily through the third day (72 hours) post-surgery

  • Total Opioid Use as Measured by Questionnaire

    Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.

    Daily through the third day (72 hours) post-surgery

Secondary Outcomes (1)

  • Pain Relief Measured by Defense and Veterans Pain Scale

    Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)

Study Arms (2)

Regional Block

ACTIVE COMPARATOR

Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).

Drug: 0.5% ropivacaine

Regional Block Plus Exparel

EXPERIMENTAL

Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.

Drug: 0.5% ropivacaineDrug: Exparel

Interventions

0.5% ropivacaineDRUG

Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Also known as: ropivacaine
Regional BlockRegional Block Plus Exparel
ExparelDRUG

106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Also known as: Liposomal bupivacaine
Regional Block Plus Exparel

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18
  • Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy

You may not qualify if:

  • Age less than 18
  • Unable to read/write English
  • Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
  • Weight \<70 kg
  • Allergy to local anesthetics
  • History of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of Percocet 5/325 mg) regularly for approximately 7 days or more OR who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation)
  • Any history of opioid misuse, illicit or prescription
  • Prior MTP joint correction on the surgical limb
  • Midfoot and hindfoot procedures performed concurrently, on the same day
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grant Medical Center

Columbus, Ohio, 43215, United States

Location

Orthopedic Foot and Ankle Center

Westerville, Ohio, 43082, United States

Location

MeSH Terms

Conditions

BunionHallux Rigidus

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesJoint Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Christopher Hyer
Organization
Orthopedic Foot and Ankle Center
hyerofac@gmail.com
614-895-8747

Study Officials

  • Christopher Hyer, DPM

    OhioHealth

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 16, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

May 17, 2017

Results First Posted

May 17, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)