Bunion, Hallux Rigidus
Conditions
Keywords
Exparel, bupivacaine, Hallux valgus deformity, bunionectomy
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.
Interventions
DRUG0.5% ropivacaine
Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
DRUGExparel
106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
Sponsors
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use as Measured by Questionnaire | Daily through the third day (72 hours) post-surgery | Compare time to first opioid use over 72 hours between groups |
| Total Opioid Use as Measured by Questionnaire | Daily through the third day (72 hours) post-surgery | Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regional Block 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).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine | 1 |
| Regional Block Plus Exparel 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.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl) | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Regional Block | Total |
|---|---|---|
| Age, Customized Age | 62 years | 62 years |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Opioid Use as Measured by Questionnaire
Compare time to first opioid use over 72 hours between groups
Time frame: Daily through the third day (72 hours) post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Block | Opioid Use as Measured by Questionnaire | 6 hours |
Primary
Total Opioid Use as Measured by Questionnaire
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Block | Total Opioid Use as Measured by Questionnaire | 18 morphine equivalents |
Secondary
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
Time frame: Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regional Block | Pain Relief Measured by Defense and Veterans Pain Scale | Pain score time 60hrs | 2 units on scale of 0 -10 |
| Regional Block | Pain Relief Measured by Defense and Veterans Pain Scale | Pain score time 0 | 0 units on scale of 0 -10 |
| Regional Block | Pain Relief Measured by Defense and Veterans Pain Scale | Pain score time 6hrs | 3 units on scale of 0 -10 |
| Regional Block | Pain Relief Measured by Defense and Veterans Pain Scale | Pain score time 12hrs | 3 units on scale of 0 -10 |
| Regional Block | Pain Relief Measured by Defense and Veterans Pain Scale | Pain score time 24hrs | 2 units on scale of 0 -10 |
| Regional Block | Pain Relief Measured by Defense and Veterans Pain Scale | Pain score time 36hrs | 3 units on scale of 0 -10 |
| Regional Block | Pain Relief Measured by Defense and Veterans Pain Scale | Pain score time 48hrs | 3 units on scale of 0 -10 |
| Regional Block | Pain Relief Measured by Defense and Veterans Pain Scale | Pain score time 72hrs | 2 units on scale of 0 -10 |