Total Shoulder ArthroplastyPhase 4NCT05068960
Postoperative Pain Control in Total Shoulder Arthroplasty
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine in people with Total Shoulder Arthroplasty, run by Scripps Clinic at 1 site in United States.
Trial summary
A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Shoulder Arthroplasty
- What is being tested?
- Liposomal bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Feb 2025
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty
Who cannot join
- Patients under the age of 50 years
- Patients over the age of 85
- Patients undergoing a revision shoulder procedure
- Documented drug or alcohol abuse
- Active narcotic use within 3 months prior to surgery
- Neurological deficit
Show all 12Show fewer
- Allergy to amide anesthetics
- Oxycodone intolerance
- Unable to take Celebrex
- Enrollment in another clinical trial
- Comorbidity that is contraindicated with the administration of an interscalene block
- Cognitive or mental health status that interferes with study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia With and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty
A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.
Read the detailed description
In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks.
This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.
- Conditions
- Total Shoulder Arthroplasty
- Being tested
- Liposomal bupivacaine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty
BupivacaineDrug
Also called Marcaine
Interscalene block with bupivacaine for pain control following total shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine [133mg]. Receives: Drug: Liposomal bupivacaine; Drug: Bupivacaine |
| Control group | Active comparator | The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic usage
Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents)
Measured: Postoperatively (up to 1 week)
Secondary outcomes (5)
Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)
Patients' self-reported pain severity and impact on functioning as measured on the Brief Pain Inventory Short-Form modified survey
Measured: Postoperatively (at 1 week)
Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively
Patients' self-reported pain as measured on the Numeric Rating Scale
Measured: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively
The ASES score is a 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. A score of 0 indicates the worst shoulder condition and a score of 100 indicates the best shoulder condition.
Measured: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)
Patients' satisfaction with results of surgery as measured on the Self-Administered Patient Satisfaction Scale
Measured: Postoperatively (at 4 weeks)
Non narcotic pain medication usage
Number and type of non-narcotic pain pills consumed during the first postoperative week
Measured: Postoperatively (up to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Mar 2021
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthroplastyStudies 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
- Double Blinded Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heinz Hoenecke, MD, Scripps Clinic
- Investigators
- Heinz Hoenecke, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068960
- Sponsor's protocol ID
- IRB-19-7479
- Status last verified
- Mar 2025
- First submitted
- 21 Jul 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia With and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT05068960
- Acronym / sponsor ID
- IRB-19-7479
- Conditions
- Total Shoulder Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Scripps ClinicUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 6 Oct 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.
A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.
Detailed description
In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks.
This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blinded Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Liposomal bupivacaine, Drug: BupivacaineThe study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine [133mg]. |
| Control group | Active comparator | Drug: BupivacaineThe control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty
Key exclusion criteria (12 listed)
- Patients under the age of 50 years
- Patients over the age of 85
- Patients undergoing a revision shoulder procedure
- Documented drug or alcohol abuse
- Active narcotic use within 3 months prior to surgery
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: ExparelAddition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty | Drug | Study group |
| BupivacaineAlso: MarcaineInterscalene block with bupivacaine for pain control following total shoulder arthroplasty | Drug | Control group, Study group |
Primary outcome
Narcotic usage
Time frame: Postoperatively (up to 1 week)
Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents)
5 secondary outcomes
Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)
Time frame: Postoperatively (at 1 week)
Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively
Time frame: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively
Time frame: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)
Time frame: Postoperatively (at 4 weeks)
Non narcotic pain medication usage
Time frame: Postoperatively (up to 1 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 21 Mar 2025.
- 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.
Heinz Hoenecke, MD principal investigator
Scripps 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 in people with Total Shoulder Arthroplasty, run by Scripps Clinic 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 1 inclusion and 12 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 21 Mar 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?
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?
Narcotic usage (time frame: Postoperatively (up to 1 week)). 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 21 Mar 2025.