Hallux Valgus (Bunions)Phase 2NCT03106545
Liposome Bupivacaine for ANKLE Blocks
A Phase 2 study testing Liposome bupivacaine in people with Hallux Valgus (Bunions), run by Catherine Vandepitte, M.D. at 1 site in Belgium.
Trial summary
Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus (Bunions)
- What is being tested?
- Liposome bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jan 2017to 31 Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years and max 65 years of age at screening
- Scheduled to undergo primary Scarf osteotomy for elective hallux valgus
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Female subject must be surgically sterile or have a monogamous partner who is surgically sterile; or be at least 2 years postmenopausal; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study
- Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch
- Able to understand the English or Dutch language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- Able to adhere to the study visit schedule, and complete all study assessments.
Who cannot join
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration
- Planned concurrent surgical procedure (e.g., bilateral hallux valgus repair)
- Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to hallux valgus and which may confound the postsurgical assessments (e.g., significant pain from other joints including chronic neuropathic pain, concurrent or prior contralateral knee or foot surgery)
- Previous hallux valgus on the foot being considered for surgery
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
- Contraindication to bupivacaine, oxycodone, morphine, or hydromorphone
Show all 19Show fewer
- Chronic daily use of long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 24 hours
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration.
- Current use of systemic glucocorticosteroids within 1 month of study enrollment
- Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration
- History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in the extremities
- Impaired kidney function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L] or blood urea nitrogen level >50 mg/dL [17.9 mmol/L]) or impaired liver function (e.g., serum aspartate aminotransferase [AST] level >3 times the upper limit of normal (ULN) or serum alanine aminotransferase [ALT] level >3 times the ULN
- Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity
- Any chronic condition or disease that would compromise neurological or vascular assessments
- Suspected or known history of drug or alcohol abuse within the previous year
- Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
- Previous participation in an EXPAREL study
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Specific Blocks of the Distal Tibial and Deep Peroneal Nerves at the Level of the Ankle With a Mixture of Bupivacaine + Liposome Bupivacaine v Bupivacaine Alone v General Anesthesia
Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid consumption as compared to bupivacaine alone or to general anesthesia.
- Conditions
- Hallux Valgus (Bunions)
- Being tested
- Liposome bupivacaine
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome bupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Single mixture LB & bupivacaine | Experimental | A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the distal tibial and deep peroneal nerves Receives: Drug: Liposome bupivacaine |
| Bupivacaine alone | Active comparator | Bupivacaine 0.5% (7.5 mL) injected into the distal tibial and deep peroneal nerves Receives: Drug: Liposome bupivacaine |
| General anesthesia | Sham comparator | General anesthesia Receives: Drug: Liposome bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in current pain over the first postoperative week
Pain rating (NRS) at rest and with movement
Measured: From baseline (before nerve block) through first postoperative week
Change in worst pain over the first postoperative week
Modified BRIEF Pain Inventory (Q1)
Measured: From discharge from PACU through first postoperative week
Secondary outcomes (6)
Opioid consumption
Self-reported consumption of Tramadol tablets
Measured: From hospital discharge through first postoperative week
Change in ability to use foot
Stand with equal weight on both feet, wiggle toes, walk 10 steps
Measured: From discharge from PACU through first postoperative week
Change in sleep quality
Duration (h), quality rating (0 - 10)
Measured: From discharge from PACU through first postoperative week
Change in satisfaction with pain control
With pain control (0 - 10)
Measured: From discharge from PACU through first postoperative week
Change in sensory response in skin dermatomes
Cold, pinprick, light touch in the distal tibial and deep peroneal nerve dermatomes
Measured: From premedication through first postoperative week
Change in motor response in foot
Plantar flexion, dorsiflexion
Measured: From premedication through first postoperative week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start2 Jan 2017
- Primary completion26 Jun 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus (Bunions)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Vandepitte, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor-investigator, Catherine Vandepitte, M.D., New York School of Regional Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106545
- Sponsor's protocol ID
- 1602
- Status last verified
- Sep 2020
- First submitted
- 24 Mar 2017
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Specific Blocks of the Distal Tibial and Deep Peroneal Nerves at the Level of the Ankle With a Mixture of Bupivacaine + Liposome Bupivacaine v Bupivacaine Alone v General Anesthesia
- ClinicalTrials.gov ID
- NCT03106545
- Acronym / sponsor ID
- 1602
- Conditions
- Hallux Valgus (Bunions)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catherine Vandepitte, M.D.University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid consumption as compared to bupivacaine alone or to general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single mixture LB & bupivacaine | Experimental | Drug: Liposome bupivacaineA single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the distal tibial and deep peroneal nerves |
| Bupivacaine alone | Active comparator | Drug: Liposome bupivacaineBupivacaine 0.5% (7.5 mL) injected into the distal tibial and deep peroneal nerves |
| General anesthesia | Sham comparator | Drug: Liposome bupivacaineGeneral anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, at least 18 years and max 65 years of age at screening
- Scheduled to undergo primary Scarf osteotomy for elective hallux valgus
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Female subject must be surgically sterile or have a monogamous partner who is surgically sterile; or be at least 2 years postmenopausal; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study
- Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch
Key exclusion criteria (19 listed)
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration
- Planned concurrent surgical procedure (e.g., bilateral hallux valgus repair)
- Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to hallux valgus and which may confound the postsurgical assessments (e.g., significant pain from other joints including chronic neuropathic pain, concurrent or prior contralateral knee or foot surgery)
- Previous hallux valgus on the foot being considered for surgery
- History of hypersensitivity or idiosyncratic reaction to amide-type 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 |
|---|---|---|
| Liposome bupivacaine | Drug | Bupivacaine alone, General anesthesia, Single mixture LB & bupivacaine |
Primary outcome
Change in current pain over the first postoperative week
Time frame: From baseline (before nerve block) through first postoperative week
Pain rating (NRS) at rest and with movement
Change in worst pain over the first postoperative week
Time frame: From discharge from PACU through first postoperative week
Modified BRIEF Pain Inventory (Q1)
6 secondary outcomes
Opioid consumption
Time frame: From hospital discharge through first postoperative week
Change in ability to use foot
Time frame: From discharge from PACU through first postoperative week
Change in sleep quality
Time frame: From discharge from PACU through first postoperative week
Change in satisfaction with pain control
Time frame: From discharge from PACU through first postoperative week
Change in sensory response in skin dermatomes
Time frame: From premedication through first postoperative week
Change in motor response in foot
Time frame: From premedication through first postoperative week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposome bupivacaine in people with Hallux Valgus (Bunions), run by Catherine Vandepitte, M.D. at 1 site in Belgium.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in current pain over the first postoperative week (time frame: From baseline (before nerve block) through first postoperative week). 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 11 Sep 2020.