Pain, PostoperativePhase 4NCT03929146
Liposomal Bupivacaine Versus Interscalene Nerve Block
A Phase 4 study testing Exparel and Interscalene Nerve Block in people with Pain, Postoperative, run by University of Cincinnati at 1 site in United States.
Trial summary
The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Exparel and Interscalene Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2019to 1 Nov 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
- patients who are older than 18 years
- patients undergoing reverse total shoulder arthroplasty
Who cannot join
- pregnancy
- inability to provide informed consent
- deemed unreliable for follow-up survey completion
- individuals who do not speak English
- those who have an allergy to the study medications (ropivicaine, bupivicaine) or have clinically significant hepatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
About this study
Official title: Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)
The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Specifically, the primary aims of this study are to compare these two interventions on the following: post-operative opioid consumption, pain scores, and patient satisfaction. Additionally, the investigators want to determine if psychological factors, catastrophizing and resilience, are associated with post-operative pain control and satisfaction. The investigators' hypothesis is that the two interventions will have similar pain control efficacy and that the liposomal bupivacaine group will experience faster post-operative recovery, earlier discharge, and improved satisfaction. The investigators also expect patient catastrophizing and resilience to significantly predict the degree of post-operative pain and level of patient satisfaction.
- Conditions
- Pain, Postoperative
- Being tested
- Exparel, Interscalene Nerve Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.
Interscalene Nerve BlockProcedure or surgery
Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Experimental | Patients in this group will receive a single intra-operative injection of liposomal bupivacaine near the surgical site (40 ml total: consisting of 20 ml 1.3% liposomal bupivacaine and 20 ml normal saline). Receives: Drug: Exparel |
| Interscalene Nerve Block | Other | Patients in this group will receive a single pre-operative interscalene nerve block in the neck/shoulder consisting of 30 ml 0.5% ropivacaine. Receives: Procedure: Interscalene Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)
Measured: 72 hours post-operatively
Visual Analog Scale Pain Scores
Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)
Measured: 72 hours post-operatively
Patient Satisfaction: Rating
Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)
Measured: 72 hours post-operatively
Relationship between catastrophizing, pain, and patient satisfaction
The effect of patient catastrophizing (measured using the Pain Catastrophizing Scale) on post-operative pain control and satisfaction. The Pain Catastrophizing Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 0 to a maximum score of 52. Higher scores on the Pain Catastrophizing Scale indicate more catastrophic thinking. The patients' catastrophizing scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between catastrophizing with pain control and satisfaction.
Measured: Catastrophizing will be measured pre-operatively
Relationship between resilience, pain, and patient satisfaction
The effect of patient resilience (measured using the Brief Resilience Scale) on post-operative pain control and satisfaction. The Brief Resilience Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 1 to a maximum score of 5. Higher scores on the Brief Resilience Scale indicate greater resilience. The patients' resilience scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between resilience with pain control and satisfaction.
Measured: Resilience will be measured pre-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start5 Feb 2019
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Schumaier, University of Cincinnati
- Investigators
- Adam Schumaier, MD, Principal investigator, University of Cincinnati, Department of Orthopaedics and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929146
- Sponsor's protocol ID
- 2017-7698
- Status last verified
- May 2023
- First submitted
- 15 Apr 2019
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)
- ClinicalTrials.gov ID
- NCT03929146
- Acronym / sponsor ID
- 2017-7698
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 26 Apr 2019 (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.
The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Specifically, the primary aims of this study are to compare these two interventions on the following: post-operative opioid consumption, pain scores, and patient satisfaction. Additionally, the investigators want to determine if psychological factors, catastrophizing and resilience, are associated with post-operative pain control and satisfaction. The investigators' hypothesis is that the two interventions will have similar pain control efficacy and that the liposomal bupivacaine group will experience faster post-operative recovery, earlier discharge, and improved satisfaction. The investigators also expect patient catastrophizing and resilience to significantly predict the degree of post-operative pain and level of patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Experimental | Drug: ExparelPatients in this group will receive a single intra-operative injection of liposomal bupivacaine near the surgical site (40 ml total: consisting of 20 ml 1.3% liposomal bupivacaine and 20 ml normal saline). |
| Interscalene Nerve Block | Other | Procedure: Interscalene Nerve BlockPatients in this group will receive a single pre-operative interscalene nerve block in the neck/shoulder consisting of 30 ml 0.5% ropivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who are older than 18 years
- patients undergoing reverse total shoulder arthroplasty
Key exclusion criteria (5 listed)
- pregnancy
- inability to provide informed consent
- deemed unreliable for follow-up survey completion
- individuals who do not speak English
- those who have an allergy to the study medications (ropivicaine, bupivicaine) or have clinically significant hepatic 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 |
|---|---|---|
| ExparelPatients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation. | Drug | Liposomal Bupivacaine |
| Interscalene Nerve BlockPatients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team. | Procedure or surgery | Interscalene Nerve Block |
Primary outcome
Opioid Consumption
Time frame: 72 hours post-operatively
Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)
Visual Analog Scale Pain Scores
Time frame: 72 hours post-operatively
Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)
Patient Satisfaction: Rating
Time frame: 72 hours post-operatively
Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)
Relationship between catastrophizing, pain, and patient satisfaction
Time frame: Catastrophizing will be measured pre-operatively
The effect of patient catastrophizing (measured using the Pain Catastrophizing Scale) on post-operative pain control and satisfaction. The Pain Catastrophizing Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 0 to a maximum score of 52. Higher scores on the Pain Catastrophizing Scale indicate more catastrophic thinking. The patients' catastrophizing scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between catastrophizing with pain control and satisfaction.
Relationship between resilience, pain, and patient satisfaction
Time frame: Resilience will be measured pre-operatively
The effect of patient resilience (measured using the Brief Resilience Scale) on post-operative pain control and satisfaction. The Brief Resilience Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 1 to a maximum score of 5. Higher scores on the Brief Resilience Scale indicate greater resilience. The patients' resilience scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between resilience with pain control and satisfaction.
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 10 May 2023.
- 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.
Adam Schumaier, MD principal investigator
University of Cincinnati, Department of Orthopaedics and Sports Medicine
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 Exparel and Interscalene Nerve Block in people with Pain, Postoperative, run by University of Cincinnati 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 5 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 10 May 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?
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?
Opioid Consumption (time frame: 72 hours post-operatively). The study lists 5 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 10 May 2023.