Back to resultsPericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
Primary Purpose
Bunion, Hallux Rigidus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0.5% ropivacaine
Exparel
Sponsored by
About this trial
This is an interventional supportive care trial for Bunion focused on measuring Exparel, bupivacaine, Hallux valgus deformity, bunionectomy
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18
- Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy
Exclusion Criteria:
- 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
Sites / Locations
- Grant Medical Center
- Orthopedic Foot and Ankle Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Regional Block
Regional Block Plus Exparel
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Opioid Use as Measured by Questionnaire
Compare time to first opioid use over 72 hours between groups
Total Opioid Use as Measured by Questionnaire
Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.
Secondary Outcome Measures
Pain Relief Measured by Defense and Veterans Pain Scale
Evaluate patient-reported pain scores (scale of 0 (no pain) - 10 (worst pain)) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02499575
Brief Title
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
Official Title
Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Logistical issues prevent efficient enrollment
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
The investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (MTP) joint procedure (bunionectomy, 1st MTP fusion, or cheilectomy). As a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). Patients are then given prescriptions for oral opioids to manage post-operative pain. The purpose of this study is to determine whether a single intrapopliteal administration of Exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bunion, Hallux Rigidus
Keywords
Exparel, bupivacaine, Hallux valgus deformity, bunionectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regional Block
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Regional Block Plus Exparel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.5% ropivacaine
Other Intervention Name(s)
ropivacaine
Intervention Description
Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Exparel
Other Intervention Name(s)
Liposomal bupivacaine
Intervention Description
106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
Primary Outcome Measure Information:
Title
Opioid Use as Measured by Questionnaire
Description
Compare time to first opioid use over 72 hours between groups
Time Frame
Daily through the third day (72 hours) post-surgery
Title
Total Opioid Use as Measured by Questionnaire
Description
Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.
Time Frame
Daily through the third day (72 hours) post-surgery
Secondary Outcome Measure Information:
Title
Pain Relief Measured by Defense and Veterans Pain Scale
Description
Evaluate patient-reported pain scores (scale of 0 (no pain) - 10 (worst pain)) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery
Time Frame
Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18
Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hyer, DPM
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Orthopedic Foot and Ankle Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
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