Liposomal BupivacainePhase 4NCT04751344
Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine HCl in people with Liposomal Bupivacaine and Postoperative Pain, run by Alexandra Black at 1 site in United States.
Trial summary
Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liposomal Bupivacaine, Postoperative Pain, Forefoot Surgery
- What is being tested?
- Liposomal bupivacaine and Bupivacaine HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to Jun 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, greater than 18 years of age
- ASA Class I or II
- Ability to take oral medication in order to assess the patient's opioid regimen postoperatively
- Forefoot surgery, including bunionectomy +/- digital surgery
- For females of reproductive potential: hCG levels will be determined during the pre-operative period. Females of childbearing age require a hCG level below 5mIU/mL in order to participate in the study. hCG levels above 25 mIU/mL is considered positive for pregnancy and, as a result, the patient will not be considered eligible for inclusion in the study
Who cannot join
- Chronic users of opioids, use for greater than 14 days in the last 3 months or nonopioid pain medications for more than 5 times per week
- Prescription for SSRIs, gabapentin, duloxetine within 3 days of surgery
- Systemic glucocorticoids within 1 month of study enrollment
- History of hepatitis
- History of peripheral vascular disease
- History of diabetes mellitus type 1 or 2
Show all 10Show fewer
- Pregnancy or lactation
- Allergic to opioids
- Known allergic reactions to components of the bupivacaine injectable or other amide anesthetics; the allergen may involve preservative compounds such as methylparaben used in the preparation of amide-type agents are metabolized to PABA
- BMI > 40
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Manhattan Eyes Ears and Throat Hospital
New York, New York, 10065
Elliot Hershman, MD
About this study
Official title: RANDOMIZED CONTROLLED TRIAL COMPARING LIPOSOMAL BUPIVACAINE VERSUS BUPIVACAINE HCL FOR POSTOPERATIVE MANAGEMENT OF FOREFOOT SURGERY
Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.
- Conditions
- Liposomal Bupivacaine, Postoperative Pain, Forefoot Surgery, Opioid Use, Bunion
- Being tested
- Liposomal bupivacaine, Bupivacaine HCl
- Medical subject headings
- Pain, Postoperative, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 8cc of liposomal bupivacaine (13.3mg/mL) will be injected around the surgical site.
Bupivacaine HClDrug
Also called Marcaine
Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 10cc of bupivacaine HCl (5mg/mL) will be injected around the surgical site.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Experimental | The liposomal bupivacaine study arm will receive 8cc (13.3 mg/mL) liposomal bupivacaine via intravenous route at the completion of the procedure. Receives: Drug: Liposomal bupivacaine |
| Bupivacaine HCl | Active comparator | The Bupivacaine HCl study arm will receive 10cc (5mg/mL) of bupivacaine HCl via intravenous route at the completion of the procedure. Receives: Drug: Bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of liposomal bupivacaine on postoperative pain control
VAS scores, which measure the intensity of pain on a scale of 1 to 10, will be collected at 2, 24, 48 and 72 hours post-operatively in order to assess therapeutic effect of local anesthetic medication for postoperative pain control.
Measured: The study will last 72 hours after the elective procedure.
Secondary outcomes (1)
Effect of liposomal bupivacaine on opioid use
We will quantify opioid use post-operatively by collecting data on total opioid consumption and time to first use of the opioid post-operatively by the patient
Measured: The study will last 72 hours after the elective procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start16 Jun 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liposomal BupivacaineStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra Black
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexandra Black, Lenox Hill Hospital
- Investigators
- Elliot Hershman, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751344
- Sponsor's protocol ID
- 101719
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 25 Feb 2021
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED CONTROLLED TRIAL COMPARING LIPOSOMAL BUPIVACAINE VERSUS BUPIVACAINE HCL FOR POSTOPERATIVE MANAGEMENT OF FOREFOOT SURGERY
- ClinicalTrials.gov ID
- NCT04751344
- Acronym / sponsor ID
- 101719
- Conditions
- Liposomal Bupivacaine, Postoperative Pain, Forefoot Surgery, Opioid Use, Bunion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandra BlackUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 12 Feb 2021 (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.
Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Experimental | Drug: Liposomal bupivacaineThe liposomal bupivacaine study arm will receive 8cc (13.3 mg/mL) liposomal bupivacaine via intravenous route at the completion of the procedure. |
| Bupivacaine HCl | Active comparator | Drug: Bupivacaine HClThe Bupivacaine HCl study arm will receive 10cc (5mg/mL) of bupivacaine HCl via intravenous route at the completion of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, greater than 18 years of age
- ASA Class I or II
- Ability to take oral medication in order to assess the patient's opioid regimen postoperatively
Key exclusion criteria (10 listed)
- Chronic users of opioids, use for greater than 14 days in the last 3 months or nonopioid pain medications for more than 5 times per week
- Prescription for SSRIs, gabapentin, duloxetine within 3 days of surgery
- Systemic glucocorticoids within 1 month of study enrollment
- History of hepatitis
- History of peripheral vascular disease
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 |
|---|---|---|
| Liposomal bupivacaineAlso: ExparelPrior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 8cc of liposomal bupivacaine (13.3mg/mL) will be injected around the surgical site. | Drug | Liposomal Bupivacaine |
| Bupivacaine HClAlso: MarcainePrior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 10cc of bupivacaine HCl (5mg/mL) will be injected around the surgical site. | Drug | Bupivacaine HCl |
Primary outcome
Effect of liposomal bupivacaine on postoperative pain control
Time frame: The study will last 72 hours after the elective procedure.
VAS scores, which measure the intensity of pain on a scale of 1 to 10, will be collected at 2, 24, 48 and 72 hours post-operatively in order to assess therapeutic effect of local anesthetic medication for postoperative pain control.
1 secondary outcome
Effect of liposomal bupivacaine on opioid use
Time frame: The study will last 72 hours after the elective procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Liposomal Bupivacaine
Not yet recruitingPhase 4
Exparel and Dexamethasone
Postoperative Pain, Shoulder Arthroscopic Surgeries
Not yet recruitingPhase 4
Smart Knee Evaluation of Exparel and Zynrelef in TKA Recovery
Total Knee Anthroplasty
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
RecruitingPhase 4
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
Local Analgesia Via Infiltration
Enrolling by invitationPhase 4
Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery
Moderate-to-severely Painful Ankle Surgery
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.
Elliot Hershman, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine HCl in people with Liposomal Bupivacaine and Postoperative Pain, run by Alexandra Black at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Black, DPM (212-570-9300, alextblack@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of liposomal bupivacaine on postoperative pain control (time frame: The study will last 72 hours after the elective procedure.). 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 25 Feb 2021.