Postoperative PainPhase 4NCT02787226
Liposomal Bupivacaine Infiltration vs Continuous Perineural Ropivacaine Infusion for Post-operative Pain After Total Shoulder Arthroplasty
A Phase 4 study testing Liposomal Bupivacaine Infiltration and Continuous Perineural Ropivicaine Infusion in people with Postoperative Pain and Shoulder Arthritis, run by Eric Shepard at 1 site in United States.
Trial summary
Total shoulder replacement is associated with considerable postoperative pain. A common method to treat and prevent this post operative pain is to place a catheter in the neck and leave it in place for up to 48 hours. The catheter delivers a medication called ropivacaine directly to a major nerve near your shoulder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Shoulder Arthritis
- What is being tested?
- Liposomal Bupivacaine Infiltration and Continuous Perineural Ropivicaine Infusion
- 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
- Aug 2014to 31 May 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting to University of Maryland Rehabilitation and Orthopaedic Institute for total shoulder arthroplasty (TSA) or reverse TSA
- Primary language is English
Who cannot join
- Allergy to either ropivacaine or bupivacaine
- On chronic opioid therapy at the time of evaluation
- Pre-existing neurologic condition which precludes the use of regional anesthesia
- Unable to provide consent as determined by the operating surgeons
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Rehabilitation and Orthopaedic Institute
Baltimore, Maryland, 21207
About this study
Official title: Bupivacaine 1.3% Liposomal Suspension (Exparel) vs Continuous Perineural Ropivacaine Infusion in the Management of Post-operative Pain Following Total Shoulder Arthroplasty; An Open-label, Randomized, Controlled Study
Total shoulder replacement is associated with considerable postoperative pain. A common method to treat and prevent this post operative pain is to place a catheter in the neck and leave it in place for up to 48 hours. The catheter delivers a medication called ropivacaine directly to a major nerve near your shoulder. It is very effective at stopping pain. In addition to preventing pain, it also prevents movement of the arm because it blocks the nerve completely.
A newer method of treating post operative pain uses only a series of small injections into the joint, skin, and muscles of the shoulder near the end of the surgery. This medication, liposomal bupivacaine (Exparel), potentially provides analgesia for greater than 48 hrs but does not require a catheter to remain in place and does not prevent patients from moving their arm after surgery because it only blocks the pain portion of the nerve. Both methods also frequently include the addition of oral and injected pain medicines like narcotics to effectively control the pain.
Ropivacaine and Exparel both work well for postoperative pain after total shoulder replacement. It is not known, however, if one method is superior in its ability to treat/prevent pain or which method may have fewer side effects. The purpose of this study is to randomly assign patients to receive either a catheter with ropivicaine or Exparel injections to help determine if one method is superior in pain relief and if either method has fewer side effects.
Read the detailed description
Patients undergoing total shoulder arthroplasty commonly receive an interscalene block using ropivacaine to provide analgesia. To provide analgesia for up to 48 hours postoperatively, an indwelling catheter can be placed and a constant infusion of ropivacaine given. This is a safe and very effective technique for managing postoperative pain in this population. This procedure is associated with reduced need for narcotics and improved patient satisfaction. Side effects are uncommon and include catheter displacement and failure of the block. A consequence of this procedure is that it causes paralysis or weakness of the affected arm until the catheter is removed and the drug wears off.
Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Inc.) was approved by the FDA in October 2011 and is indicated for administration into a surgical site to produce postsurgical analgesia. The duration of analgesia from a single administration is up to 72 hours. Like the ropivicaine constant infusion, Exparel is associated with good patient satisfaction and reduced narcotics requirement. Its advantage over a continuous infusion is that it is technically far less challenging to administer than a catheter insertion and it does not cause paralysis of the affected arm.
Investigators are unaware of any studies that compare the efficacy, patient satisfaction, and complication rates of these two different procedures. It is, therefore, the purpose of this investigation to explore these differences. Investigators aim to randomly assign 100 subjects in an open-labeled fashion who are scheduled to have a total shoulder arthroplasty at the UMROI to receive either a continuous infusion of ropivicaine via an interscalene catheter or a single administration of a single dose interscalene nerve block plus Exparel injected into the soft tissue within and around the shoulder during surgery.
In this study, investigators plan to use an open label randomized control trial to compare the efficacy of a one time dose of liposomal bupivacaine vs. ropivacaine infusion over 36 hours in providing analgesia. All patients will receive an interscalene block with ropivacaine for operative anesthesia. The patients will be randomized to either receive an indwelling interscalene catheter with a continuous infusion of 6 ml per hour of 0.2% ropivacaine, or surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension. The patients will be given rescue pain medications as needed and will not be subjected to suffer pain if their pain is not controlled by their local anesthetic. Investigators plan to compare the amounts of rescue pain medications used by the individuals in both groups and the patient reported pain scores to help determine whether local infiltration of liposomal bupivacaine is as effective as a ropivacaine infusion for providing analgesia. If the surgical wound infiltration of liposomal bupivacaine provides the same or improved analgesia, this would benefit future patients and not subject them to having a peripheral nerve catheter placed as they would get equivalent pain relief from a single shot injection followed by wound infiltration with local anesthetic.
- Conditions
- Postoperative Pain, Shoulder Arthritis
- Being tested
- Liposomal Bupivacaine Infiltration, Continuous Perineural Ropivicaine Infusion
- Keywords
- liposomal bupivacaine, analgesia for total shoulder arthroplasty, peripheral nerve blocks for total shoulder arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine InfiltrationDrug
Also called Exparel
Surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension.
Continuous Perineural Ropivicaine InfusionDrug
Indwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| TSA - Liposomal Bupivacaine Infiltration | Active comparator | Surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension for postoperative analgesia after total shoulder arthroplasty (TSA). Receives: Drug: Liposomal Bupivacaine Infiltration |
| Reverse TSA - Liposomal Bupivacaine Infiltration | Active comparator | Surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension for postoperative analgesia after reverse total shoulder arthroplasty (TSA). Receives: Drug: Liposomal Bupivacaine Infiltration |
| TSA - Continuous Perineural Ropivacaine Infusion | Active comparator | Indwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine for postoperative analgesia after TSA. Receives: Drug: Continuous Perineural Ropivicaine Infusion |
| Reverse TSA - Continuous Perineural Ropivacaine Infusion | Active comparator | Indwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine for postoperative analgesia after reverse TSA. Receives: Drug: Continuous Perineural Ropivicaine Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Measured: 0-36 hours post-operatively
Secondary outcomes (4)
Opioid-Related Adverse Events
nausea, vomiting, sedation, constipation, dizziness, respiratory depression
Measured: 0-36 hours post-operatively
Length of stay
Measured: 1-3 days
Rescue pain medication requirement
Measured: 0-36 hours postoperatively
Patient satisfaction
by satisfaction survey over the phone
Measured: at 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startAug 2014
- Primary completion28 Apr 2017
- Study completion31 May 2017
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Shepard
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor-investigator, Eric Shepard, University of Maryland
- Investigators
- Eric K Shepard, MD, Principal investigator, University of Maryland Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787226
- Sponsor's protocol ID
- HP-00054364
- Status last verified
- Feb 2018
- First submitted
- 26 May 2016
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grant GJ, Lax J, Susser L, Zakowski M, Weissman TE, Turndorf H. Wound infiltration with liposomal bupivacaine prolongs analgesia in rats. Acta Anaesthesiol Scand. 1997 Feb;41(2):204-7. doi: 10.1111/j.1399-6576.1997.tb04666.x.
PubMed 9062600Grant GJ, Barenholz Y, Bolotin EM, Bansinath M, Turndorf H, Piskoun B, Davidson EM. A novel liposomal bupivacaine formulation to produce ultralong-acting analgesia. Anesthesiology. 2004 Jul;101(1):133-7. doi: 10.1097/00000542-200407000-00021.
PubMed 15220782Hollmann MW, Durieux ME, Graf BM. Novel local anaesthetics and novel indications for local anaesthetics. Curr Opin Anaesthesiol. 2001 Dec;14(6):741-9. doi: 10.1097/00001503-200112000-00023.
PubMed 17019174
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine 1.3% Liposomal Suspension (Exparel) vs Continuous Perineural Ropivacaine Infusion in the Management of Post-operative Pain Following Total Shoulder Arthroplasty; An Open-label, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02787226
- Acronym / sponsor ID
- HP-00054364
- Conditions
- Postoperative Pain, Shoulder Arthritis
- Keywords
- liposomal bupivacaine, analgesia for total shoulder arthroplasty, peripheral nerve blocks for total shoulder arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eric ShepardUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- Aug 2014
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 1 Jun 2016 (estimated)
- 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.
Total shoulder replacement is associated with considerable postoperative pain. A common method to treat and prevent this post operative pain is to place a catheter in the neck and leave it in place for up to 48 hours. The catheter delivers a medication called ropivacaine directly to a major nerve near your shoulder. It is very effective at stopping pain. In addition to preventing pain, it also prevents movement of the arm because it blocks the nerve completely.
A newer method of treating post operative pain uses only a series of small injections into the joint, skin, and muscles of the shoulder near the end of the surgery. This medication, liposomal bupivacaine (Exparel), potentially provides analgesia for greater than 48 hrs but does not require a catheter to remain in place and does not prevent patients from moving their arm after surgery because it only blocks the pain portion of the nerve. Both methods also frequently include the addition of oral and injected pain medicines like narcotics to effectively control the pain.
Ropivacaine and Exparel both work well for postoperative pain after total shoulder replacement. It is not known, however, if one method is superior in its ability to treat/prevent pain or which method may have fewer side effects. The purpose of this study is to randomly assign patients to receive either a catheter with ropivicaine or Exparel injections to help determine if one method is superior in pain relief and if either method has fewer side effects.
Detailed description
Patients undergoing total shoulder arthroplasty commonly receive an interscalene block using ropivacaine to provide analgesia. To provide analgesia for up to 48 hours postoperatively, an indwelling catheter can be placed and a constant infusion of ropivacaine given. This is a safe and very effective technique for managing postoperative pain in this population. This procedure is associated with reduced need for narcotics and improved patient satisfaction. Side effects are uncommon and include catheter displacement and failure of the block. A consequence of this procedure is that it causes paralysis or weakness of the affected arm until the catheter is removed and the drug wears off.
Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Inc.) was approved by the FDA in October 2011 and is indicated for administration into a surgical site to produce postsurgical analgesia. The duration of analgesia from a single administration is up to 72 hours. Like the ropivicaine constant infusion, Exparel is associated with good patient satisfaction and reduced narcotics requirement. Its advantage over a continuous infusion is that it is technically far less challenging to administer than a catheter insertion and it does not cause paralysis of the affected arm.
Investigators are unaware of any studies that compare the efficacy, patient satisfaction, and complication rates of these two different procedures. It is, therefore, the purpose of this investigation to explore these differences. Investigators aim to randomly assign 100 subjects in an open-labeled fashion who are scheduled to have a total shoulder arthroplasty at the UMROI to receive either a continuous infusion of ropivicaine via an interscalene catheter or a single administration of a single dose interscalene nerve block plus Exparel injected into the soft tissue within and around the shoulder during surgery.
In this study, investigators plan to use an open label randomized control trial to compare the efficacy of a one time dose of liposomal bupivacaine vs. ropivacaine infusion over 36 hours in providing analgesia. All patients will receive an interscalene block with ropivacaine for operative anesthesia. The patients will be randomized to either receive an indwelling interscalene catheter with a continuous infusion of 6 ml per hour of 0.2% ropivacaine, or surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension. The patients will be given rescue pain medications as needed and will not be subjected to suffer pain if their pain is not controlled by their local anesthetic. Investigators plan to compare the amounts of rescue pain medications used by the individuals in both groups and the patient reported pain scores to help determine whether local infiltration of liposomal bupivacaine is as effective as a ropivacaine infusion for providing analgesia. If the surgical wound infiltration of liposomal bupivacaine provides the same or improved analgesia, this would benefit future patients and not subject them to having a peripheral nerve catheter placed as they would get equivalent pain relief from a single shot injection followed by wound infiltration with local anesthetic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TSA - Liposomal Bupivacaine Infiltration | Active comparator | Drug: Liposomal Bupivacaine InfiltrationSurgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension for postoperative analgesia after total shoulder arthroplasty (TSA). |
| Reverse TSA - Liposomal Bupivacaine Infiltration | Active comparator | Drug: Liposomal Bupivacaine InfiltrationSurgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension for postoperative analgesia after reverse total shoulder arthroplasty (TSA). |
| TSA - Continuous Perineural Ropivacaine Infusion | Active comparator | Drug: Continuous Perineural Ropivicaine InfusionIndwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine for postoperative analgesia after TSA. |
| Reverse TSA - Continuous Perineural Ropivacaine Infusion | Active comparator | Drug: Continuous Perineural Ropivicaine InfusionIndwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine for postoperative analgesia after reverse TSA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presenting to University of Maryland Rehabilitation and Orthopaedic Institute for total shoulder arthroplasty (TSA) or reverse TSA
- Primary language is English
Key exclusion criteria (4 listed)
- Allergy to either ropivacaine or bupivacaine
- On chronic opioid therapy at the time of evaluation
- Pre-existing neurologic condition which precludes the use of regional anesthesia
- Unable to provide consent as determined by the operating surgeons
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 InfiltrationAlso: ExparelSurgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension. | Drug | Reverse TSA - Liposomal Bupivacaine Infiltration, TSA - Liposomal Bupivacaine Infiltration |
| Continuous Perineural Ropivicaine InfusionIndwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine. | Drug | Reverse TSA - Continuous Perineural Ropivacaine Infusion, TSA - Continuous Perineural Ropivacaine Infusion |
Primary outcome
Pain scores
Time frame: 0-36 hours post-operatively
4 secondary outcomes
Opioid-Related Adverse Events
Time frame: 0-36 hours post-operatively
Length of stay
Time frame: 1-3 days
Rescue pain medication requirement
Time frame: 0-36 hours postoperatively
Patient satisfaction
Time frame: at 3 months post-operatively
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Background: PubMed 9062600Grant GJ, Lax J, Susser L, Zakowski M, Weissman TE, Turndorf H. Wound infiltration with liposomal bupivacaine prolongs analgesia in rats. Acta Anaesthesiol Scand. 1997 Feb;41(2):204-7. doi: 10.1111/j.1399-6576.1997.tb04666.x.
- Background: PubMed 15220782Grant GJ, Barenholz Y, Bolotin EM, Bansinath M, Turndorf H, Piskoun B, Davidson EM. A novel liposomal bupivacaine formulation to produce ultralong-acting analgesia. Anesthesiology. 2004 Jul;101(1):133-7. doi: 10.1097/00000542-200407000-00021.
- Background: PubMed 17019174Hollmann MW, Durieux ME, Graf BM. Novel local anaesthetics and novel indications for local anaesthetics. Curr Opin Anaesthesiol. 2001 Dec;14(6):741-9. doi: 10.1097/00001503-200112000-00023.
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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.
Eric K Shepard, MD principal investigator
University of Maryland Department of Anesthesiology
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 Infiltration and Continuous Perineural Ropivicaine Infusion in people with Postoperative Pain and Shoulder Arthritis, run by Eric Shepard 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: stopped early, as of the sponsor's last update on 9 Feb 2018. 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 was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Pain scores (time frame: 0-36 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02787226, which also lists 3 linked publications.
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 9 Feb 2018.