Fracture of Shoulder and Upper ArmPhase 4NCT02472314
Exparel for Postoperative Pain Management in Shoulder Surgery
A Phase 4 study testing 1.3% Liposomal Bupivacaine and 0.125% Bupivacaine in people with Fracture of Shoulder and Upper Arm, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Shoulder and Upper Arm
- What is being tested?
- 1.3% Liposomal Bupivacaine and 0.125% Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to May 2017
- Phase
- Phase 4
- 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
- Patients undergoing shoulder arthroplasty under general anesthesia
- Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
- Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
- Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
- Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
- Patients available for follow up routine post-operative clinic visits, per standard of care.
Who cannot join
- Contraindications to regional anesthesia
- Significant peripheral neuropathy or neurological disorder affecting the upper extremity
- Contraindication to a component of multimodal analgesia
- Pregnancy
- Opioid tolerance
- Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University Physician Group
Dearborn, Michigan, 48124
About this study
Official title: A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
Read the detailed description
liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.
- Conditions
- Fracture of Shoulder and Upper Arm
- Being tested
- 1.3% Liposomal Bupivacaine, 0.125% Bupivacaine
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.3% Liposomal BupivacaineDrug
Also called Exparel
local tissue infiltration of Liposomal Bupivacaine during surgery
0.125% BupivacaineDrug
Also called Bupivacaine
Continues nerve block with Bupivacaine during surgery and postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine A | Experimental | One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty Receives: Drug: 1.3% Liposomal Bupivacaine |
| CISB control for A | Active comparator | Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty . Receives: Drug: 0.125% Bupivacaine |
| Liposomal Bupivacaine B | Experimental | One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation Receives: Drug: 1.3% Liposomal Bupivacaine |
| CISB control for B | Active comparator | Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation Receives: Drug: 0.125% Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Analgesia
Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
Measured: 30 days
Secondary outcomes (4)
Post Operative American Shoulder and Elbow Surgeons (ASES)
American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome.
Measured: Preoperative, 6 weeks and last follow up
Subjective Shoulder Value (SSV)
Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100%
Measured: Pre-operative, 6 weeks and last Follow up
Incidence of Nerve Injury
Neuropraxia on the treatment side
Measured: During hospital stay and at 2 weeks and 6 weeks post-operatively
Post Operative Opioid Consumption
Cumulative amount of opioids administered during the time frame
Measured: During hospital stay up to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2017
- Study completionMay 2017
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 Fracture of Shoulder and Upper ArmStudies 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
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vani J. Sabesan, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472314
- Sponsor's protocol ID
- 2014-193
- Status last verified
- Dec 2023
- First submitted
- 3 Jun 2015
- Last updated
- 29 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation
- ClinicalTrials.gov ID
- NCT02472314
- Acronym / sponsor ID
- 2014-193
- Conditions
- Fracture of Shoulder and Upper Arm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
Detailed description
liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine A | Experimental | Drug: 1.3% Liposomal BupivacaineOne time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty |
| CISB control for A | Active comparator | Drug: 0.125% BupivacainePeripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty . |
| Liposomal Bupivacaine B | Experimental | Drug: 1.3% Liposomal BupivacaineOne time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation |
| CISB control for B | Active comparator | Drug: 0.125% BupivacainePeripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing shoulder arthroplasty under general anesthesia
- Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
- Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
- Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
- Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
Key exclusion criteria (6 listed)
- Contraindications to regional anesthesia
- Significant peripheral neuropathy or neurological disorder affecting the upper extremity
- Contraindication to a component of multimodal analgesia
- Pregnancy
- Opioid tolerance
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 |
|---|---|---|
| 1.3% Liposomal BupivacaineAlso: Exparellocal tissue infiltration of Liposomal Bupivacaine during surgery | Drug | Liposomal Bupivacaine A, Liposomal Bupivacaine B |
| 0.125% BupivacaineAlso: BupivacaineContinues nerve block with Bupivacaine during surgery and postoperatively | Drug | CISB control for A, CISB control for B |
Primary outcome
Quality of Analgesia
Time frame: 30 days
Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
4 secondary outcomes
Post Operative American Shoulder and Elbow Surgeons (ASES)
Time frame: Preoperative, 6 weeks and last follow up
Subjective Shoulder Value (SSV)
Time frame: Pre-operative, 6 weeks and last Follow up
Incidence of Nerve Injury
Time frame: During hospital stay and at 2 weeks and 6 weeks post-operatively
Post Operative Opioid Consumption
Time frame: During hospital stay up to 48 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 4 study testing 1.3% Liposomal Bupivacaine and 0.125% Bupivacaine in people with Fracture of Shoulder and Upper Arm, run by Wayne State University 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 6 inclusion and 6 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 29 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2019). 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?
Quality of Analgesia (time frame: 30 days). 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 29 Dec 2023.