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Logistical issues prevent efficient enrollment
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% ropivacaine | Drug | Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Hyer, DPM | OhioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grant Medical Center | Columbus | Ohio | 43215 | United States | ||
| Orthopedic Foot and Ankle Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Use as Measured by Questionnaire | Compare time to first opioid use over 72 hours between groups | Posted | Number | hours | Daily through the third day (72 hours) post-surgery |
|
up to 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Hyer | Orthopedic Foot and Ankle Center | 614-895-8747 | hyerofac@gmail.com |
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| ID | Term |
|---|---|
| D000071378 | Bunion |
| D020859 | Hallux Rigidus |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Exparel | Drug | 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl) |
|
|
| Westerville |
| Ohio |
| 43082 |
| United States |
| 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Total Opioid Use as Measured by Questionnaire | Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups. | Posted | Number | morphine equivalents | Daily through the third day (72 hours) post-surgery |
|
|
|
| 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 | Posted | Number | units on scale of 0 -10 | Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery) |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 1 | 0 | 1 |
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| D000588 |
| Amines |
| Title | Measurements |
|---|---|
|
| Pain score time 24hrs |
|
| Pain score time 36hrs |
|
| Pain score time 48hrs |
|
| Pain score time 60hrs |
|
| Pain score time 72hrs |
|