Hand SurgeryPhase 4NCT06806410
The Efficacy of Liposomal Bupivacaine in Ultrasound Guided Supraclavicular Nerve Blocks for Hand and Wrist Surgery
A Phase 4 study testing Liposomal bupivacaine (LB) and Dexamethasone in people with Hand Surgery and Wrist Surgery, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
Patients undergoing hand, wrist, and elbow surgery may experience pain after surgery. The orthopedic surgeon may provide prescription pain medications after surgery to assist with pain control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Surgery, Wrist Surgery, Elbow Surgery
- What is being tested?
- Liposomal bupivacaine (LB) and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Jan 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- patients scheduled to undergo finger, hand, wrist, elbow surgery with a hand surgeon at St. Luke's University Hospital in Bethlehem, Pennsylvania
- patients greater than 18 years of age, able to provide written consent for surgery and study
Who cannot join
- patients that cannot provide written consent for finger, hand, wrist, elbow surgery
- patients with known allergies to local anesthetics
- patients with severe liver disease
- patients with a condition known as methemoglobinemia
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
About this study
Official title: The Efficacy of Liposomal Bupivacaine in Ultrasound Guided Supraclavicular Nerve Blocks for Hand and Wrist Surgery: a Prospective, Randomized, Blinded Controlled Trial
Patients undergoing hand, wrist, and elbow surgery may experience pain after surgery. The orthopedic surgeon may provide prescription pain medications after surgery to assist with pain control. However, with concern of the opioid epidemic, many patients would rather minimize the use of narcotic pain prescriptions after having surgery. As an alternative, ultrasound guided regional nerve blocks can assist with postoperative pain control.
patients consented to this study will be randomized into three groups: 1) will receive an ultrasound guided nerve block with local anesthesia only, 2) will receive an ultrasound guided nerve block with local anesthesia and a steroid dexamethasone, 3) will receive an ultrasound guided nerve block with liposomal bupivacaine.
our study team will make phone calls after surgery to the patient to determine how long the block lasted for, and how many opioid pain pills were taken up to 3 days after surgery.
Read the detailed description
Our study team predicts that the ultrasound guided nerve block with liposomal bupivacaine can last approximately 48 hours, while the block with local anesthesia and dexamethasone will last approximately 30 hours, and the block with local anesthesia only may last up to 24 hours
- Conditions
- Hand Surgery, Wrist Surgery, Elbow Surgery, Fracture Fixation, Dupuytren Contracture, Finger Fracture
- Being tested
- Liposomal bupivacaine (LB), Dexamethasone
- Keywords
- liposomal bupivacaine, supraclavicular nerve block, ultrasound guided nerve block, hand, wrist, elbow surgery, local anesthetic, dexamethasone perineural injection
- Medical subject headings
- Dupuytren Contracture, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaine (LB)Drug
Also called liposomal bupivacaine, exparel
our study team wishes to determine effect of liposomal bupivacaine in regional nerve blocks for surgery of the upper extremity (finger, hand, wrist, elbow)
DexamethasoneDrug
Also called decadron perineural injection
dexamethasone injected in perineural area can extend the regional nerve block
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: local anesthesia only in ultrasound guided supraclavicular nerve block | No intervention | ultrasound guided supraclavicular nerve blocks are typically performed with the use of local anesthesia only |
| Study Arm: local anesthesia with perineural dexamethasone | Experimental | dexamethasone is a potent steroid that when provided in ultrasound guided nerve blocks can extend the duration of the nerve block. Receives: Drug: Dexamethasone |
| Study Arm: liposomal bupivacaine | Experimental | our study team would like to determine how use of liposomal bupivacaine in supraclavicular nerve blocks can lengthen the duration of the nerve block, and how it may affect the number of opioid pills used after surgery up until postoperative day three. Receives: Drug: Liposomal bupivacaine (LB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective length of duration of block
our study team contacts the patients 4 days after surgery to ask how long their regional nerve block lasted
Measured: feedback obtained up until day 3 after surgery
Secondary outcomes (1)
Number of opioid pills taken until postoperative day 3
our study team contacts the patients to ask how many opioid pain pills were taken from arrival to home up until postoperative day 3
Measured: feedback until day 3 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 May 2023
- Primary completion30 Nov 2024
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization into three groups. Control group is administration of local anesthesia in ultrasound guided supraclavicular nerve blocks. There are two study groups. The intermediate study group is administration of local anesthesia with dexamethasone in the ultrasound guided supraclavicular nerve block. The other study group is administration of liposomal bupivacaine in the ultrasound guided supraclavicular nerve block.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Ng-Pellegrino, MD, Principal investigator, St. Luke's Hospital and Health Network, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806410
- Sponsor's protocol ID
- SLIR2023-34
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will provide results on our measured outcomes: subjective length of duration of block, number of opioid pills taken by postsurgical day 3. we will provide de-identified information on demographics as well between the control arm and treatment arms
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Liposomal Bupivacaine in Ultrasound Guided Supraclavicular Nerve Blocks for Hand and Wrist Surgery: a Prospective, Randomized, Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT06806410
- Acronym / sponsor ID
- SLIR2023-34
- Conditions
- Hand Surgery, Wrist Surgery, Elbow Surgery, Fracture Fixation, Dupuytren Contracture, Finger Fracture
- Keywords
- liposomal bupivacaine, supraclavicular nerve block, ultrasound guided nerve block, hand, wrist, elbow surgery, local anesthetic, dexamethasone perineural injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 4 Feb 2025 (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.
Patients undergoing hand, wrist, and elbow surgery may experience pain after surgery. The orthopedic surgeon may provide prescription pain medications after surgery to assist with pain control. However, with concern of the opioid epidemic, many patients would rather minimize the use of narcotic pain prescriptions after having surgery. As an alternative, ultrasound guided regional nerve blocks can assist with postoperative pain control.
patients consented to this study will be randomized into three groups: 1) will receive an ultrasound guided nerve block with local anesthesia only, 2) will receive an ultrasound guided nerve block with local anesthesia and a steroid dexamethasone, 3) will receive an ultrasound guided nerve block with liposomal bupivacaine.
our study team will make phone calls after surgery to the patient to determine how long the block lasted for, and how many opioid pain pills were taken up to 3 days after surgery.
Detailed description
Our study team predicts that the ultrasound guided nerve block with liposomal bupivacaine can last approximately 48 hours, while the block with local anesthesia and dexamethasone will last approximately 30 hours, and the block with local anesthesia only may last up to 24 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomization into three groups. Control group is administration of local anesthesia in ultrasound guided supraclavicular nerve blocks. There are two study groups. The intermediate study group is administration of local anesthesia with dexamethasone in the ultrasound guided supraclavicular nerve block. The other study group is administration of liposomal bupivacaine in the ultrasound guided supraclavicular nerve block.
| Arm | Type | Receives |
|---|---|---|
| Control Arm: local anesthesia only in ultrasound guided supraclavicular nerve block | No intervention | –ultrasound guided supraclavicular nerve blocks are typically performed with the use of local anesthesia only |
| Study Arm: local anesthesia with perineural dexamethasone | Experimental | Drug: Dexamethasonedexamethasone is a potent steroid that when provided in ultrasound guided nerve blocks can extend the duration of the nerve block. |
| Study Arm: liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaine (LB)our study team would like to determine how use of liposomal bupivacaine in supraclavicular nerve blocks can lengthen the duration of the nerve block, and how it may affect the number of opioid pills used after surgery up until postoperative day three. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled to undergo finger, hand, wrist, elbow surgery with a hand surgeon at St. Luke's University Hospital in Bethlehem, Pennsylvania
- patients greater than 18 years of age, able to provide written consent for surgery and study
Key exclusion criteria (4 listed)
- patients that cannot provide written consent for finger, hand, wrist, elbow surgery
- patients with known allergies to local anesthetics
- patients with severe liver disease
- patients with a condition known as methemoglobinemia
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 bupivacaine (LB)Also: liposomal bupivacaine, exparelour study team wishes to determine effect of liposomal bupivacaine in regional nerve blocks for surgery of the upper extremity (finger, hand, wrist, elbow) | Drug | Study Arm: liposomal bupivacaine |
| DexamethasoneAlso: decadron perineural injectiondexamethasone injected in perineural area can extend the regional nerve block | Drug | Study Arm: local anesthesia with perineural dexamethasone |
Primary outcome
Subjective length of duration of block
Time frame: feedback obtained up until day 3 after surgery
our study team contacts the patients 4 days after surgery to ask how long their regional nerve block lasted
1 secondary outcome
Number of opioid pills taken until postoperative day 3
Time frame: feedback until day 3 after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Yes. we will provide results on our measured outcomes: subjective length of duration of block, number of opioid pills taken by postsurgical day 3. we will provide de-identified information on demographics as well between the control arm and treatment arms
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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.
Anna Ng-Pellegrino, MD principal investigator
St. Luke's Hospital and Health Network, Pennsylvania
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 (LB) and Dexamethasone in people with Hand Surgery and Wrist Surgery, run by St. Luke's Hospital, Pennsylvania 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Subjective length of duration of block (time frame: feedback obtained up until day 3 after surgery). 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 6 Feb 2025.