BunionNCT02499575
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
A study testing 0.5% ropivacaine and Exparel in people with Bunion and Hallux Rigidus, run by OhioHealth at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bunion, Hallux Rigidus
- What is being tested?
- 0.5% ropivacaine and Exparel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grant Medical Center
Columbus, Ohio, 43215
Orthopedic Foot and Ankle Center
Westerville, Ohio, 43082
About this study
Official title: Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy
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).
Read the 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.
- Conditions
- Bunion, Hallux Rigidus
- Being tested
- 0.5% ropivacaine, Exparel
- Keywords
- Exparel, bupivacaine, Hallux valgus deformity, bunionectomy
- Medical subject headings
- Bunion, Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% ropivacaineDrug
Also called ropivacaine
Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
ExparelDrug
Also called Liposomal bupivacaine
106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: 0.5% ropivacaine; Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use as Measured by Questionnaire
Compare time to first opioid use over 72 hours between groups
Measured: 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.
Measured: Daily through the third day (72 hours) post-surgery
Secondary outcomes (1)
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
Measured: Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionJul 2016
Why it stopped: Logistical issues prevent efficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BunionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Hyer, DPM, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499575
- Sponsor's protocol ID
- OH2-15-0005
- Status last verified
- Jul 2016
- First submitted
- 2 Jul 2015
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy
- ClinicalTrials.gov ID
- NCT02499575
- Acronym / sponsor ID
- OH2-15-0005
- Conditions
- Bunion, Hallux Rigidus
- Keywords
- Exparel, bupivacaine, Hallux valgus deformity, bunionectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical issues prevent efficient enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional Block | Active comparator | Drug: 0.5% ropivacaineGroup 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 | Drug: 0.5% ropivacaine, Drug: ExparelGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% ropivacaineAlso: ropivacaineAdductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine | Drug | Regional Block, Regional Block Plus Exparel |
| ExparelAlso: Liposomal bupivacaine106 mg (8 mL, equivalent to 120 mg bupivacaine HCl) | Drug | Regional Block Plus Exparel |
Primary outcome
Opioid Use as Measured by Questionnaire
Time frame: 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
Time frame: Daily through the third day (72 hours) post-surgery
Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.
1 secondary outcome
Pain Relief Measured by Defense and Veterans Pain Scale
Time frame: Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Hyer, DPM principal investigator
OhioHealth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5% ropivacaine and Exparel in people with Bunion and Hallux Rigidus, run by OhioHealth at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use as Measured by Questionnaire (time frame: Daily through the third day (72 hours) post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.