Pain, PostoperativePhase 4NCT03474510
Effective Pain Management During Shoulder Replacement Surgery With EXPAREL
A Phase 4 study testing local infiltration of liposomal bupivacaine and continuous infusion of ropivacaine interscalene nerve block in people with Pain, Postoperative and Shoulder Osteoarthritis, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of post-operative pain control of local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Shoulder Osteoarthritis
- What is being tested?
- local infiltration of liposomal bupivacaine and continuous infusion of ropivacaine interscalene nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2018to 1 Feb 2019
- 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
- Surgical candidate for primary total shoulder replacement or reverse total shoulder replacement
- Patient must be 18 years or older
- Patient must be willing and able to sign IRB approved informed consent form, and must be able to understand and agree to follow study protocol.
Who cannot join
- Severe bronchopulmonary disease
- Oxygen dependent
- Existing nerve injury
- BMI > 40
- Coagulation disorders
- Allergy to ropivicaine or bupivacaine
Show all 12Show fewer
- History of drug or alcohol abuse
- Opioid use within 3 days prior to surgery
- ASA physical status > lll
- Discharge plan to Skilled nursing facility
- Pregnant women
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Pain Management During Shoulder Replacement Surgery With Either Continuous Ropivacaine Interscalene Nerve Block or Local Infiltration With EXPAREL After Single Shot Injection Ropivacaine Interscalene Nerve Block
The purpose of this study is to examine the effectiveness of post-operative pain control of local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.
Read the detailed description
Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of pain that may require opioid consumption for several days post-operatively. The side effects of opioids are numerous, and ropivacaine administered pre-operatively via interscalene nerve block, with a post-operative continuous ropivacaine infusion through an indwelling catheter (CINB) is a highly effective method for controlling pain and reducing opioid consumption and side effects. While CINB provides adequate post-operative analgesia, and may extend post-operative pain relief for up to 48 hours, there are some risks associated with CINB ranging from catheter tip withdrawal to more serious complications including catheter tip beakage, brachial plexus injury, and pulmonary complications. Local infiltration of liposomal bupivacaine (EXPAREL Pacira Pharmaceuticals, Inc., Parsippany, New Jersey) may provide longer-lasting pain relief when compared to single shot INB (SSINB), and reduce opioid consumption at 24 hours, 48 hours and 72 hours post-op. Studies have shown inconsistency in the effectiveness of EXPAREL, and one proposed reason is the method of administration. Clinicians experienced in their infiltration technique demonstrated greater improvement in pain-related outcomes. The first 48 hours post-op present the most likely opportunity for reducing narcotic administration, which increases the value of attempting to reduce opioid consumption during this period. The cost of EXPAREL LIA, is slightly less than the cost of CINB, and if pain control is comparable, may benefit the patient in reducing hospital costs. The purpose of this study is to examine the effectiveness of pain control of local infiltration of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.
- Conditions
- Pain, Postoperative, Shoulder Osteoarthritis
- Being tested
- local infiltration of liposomal bupivacaine, continuous infusion of ropivacaine interscalene nerve block
- Keywords
- pain control, EXPAREL, shoulder surgery, continuous interscalene nerve block
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local infiltration of liposomal bupivacaineDrug
Those patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue.
continuous infusion of ropivacaine interscalene nerve blockOther
All patients will receive a single injection of 30mL, 0.5% preservative-free ropivacaine.
Those patients randomized to receive CINB will then have an indwelling catheter placed and held in place by Dermabond and Tegaderm. Placement will be confirmed by ultrasound. Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer.
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL | Experimental | Those patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue. Receives: Drug: local infiltration of liposomal bupivacaine |
| interscalene nerve block | Active comparator | Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer. Receives: Other: continuous infusion of ropivacaine interscalene nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Opioid consumption in morphine equivalents within the first 24 hours post-operatively.
Measured: post-operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start17 Mar 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Why it stopped: Investigator Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474510
- Sponsor's protocol ID
- 17-025
- Status last verified
- Feb 2021
- First submitted
- 16 Mar 2018
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers. De-identified results will be shared via publication, and conference.
Publications
Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
PubMed 20565394Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. Br J Anaesth. 1998 Oct;81(4):603-5. doi: 10.1093/bja/81.4.603.
PubMed 9924240Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Jun;96(6):1297-304. doi: 10.1097/00000542-200206000-00006.
PubMed 12170039Bjornholdt KT, Jensen JM, Bendtsen TF, Soballe K, Nikolajsen L. Local infiltration analgesia versus continuous interscalene brachial plexus block for shoulder replacement pain: a randomized clinical trial. Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1245-52. doi: 10.1007/s00590-015-1678-2. Epub 2015 Aug 15.
PubMed 26276164Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, Kolowich PA, Muh SJ. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg. 2016 Nov;25(11):1742-1748. doi: 10.1016/j.jse.2016.05.007. Epub 2016 Jul 14.
PubMed 27422692Hannan CV, Albrecht MJ, Petersen SA, Srikumaran U. Liposomal Bupivacaine vs Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Retrospective Cohort Analysis. Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):424-430.
PubMed 28005096Jefferey D. Angel M, Chris A. Steel JR, Devin Ong, PhD, Heather Watson, PhD, Scott T. Lovald, PhD. Pain Control after Total and Reverse Shoulder Arthroplasty: Interscalene Block vs. Liposomal Bupivacaine. In: AAOS Annual Meeting. 2016
Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.
PubMed 22410178
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Pain Management During Shoulder Replacement Surgery With Either Continuous Ropivacaine Interscalene Nerve Block or Local Infiltration With EXPAREL After Single Shot Injection Ropivacaine Interscalene Nerve Block
- ClinicalTrials.gov ID
- NCT03474510
- Acronym / sponsor ID
- 17-025
- Conditions
- Pain, Postoperative, Shoulder Osteoarthritis
- Keywords
- pain control, EXPAREL, shoulder surgery, continuous interscalene nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 17 Mar 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 22 Mar 2018 (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 purpose of this study is to examine the effectiveness of post-operative pain control of local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.
Detailed description
Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of pain that may require opioid consumption for several days post-operatively. The side effects of opioids are numerous, and ropivacaine administered pre-operatively via interscalene nerve block, with a post-operative continuous ropivacaine infusion through an indwelling catheter (CINB) is a highly effective method for controlling pain and reducing opioid consumption and side effects. While CINB provides adequate post-operative analgesia, and may extend post-operative pain relief for up to 48 hours, there are some risks associated with CINB ranging from catheter tip withdrawal to more serious complications including catheter tip beakage, brachial plexus injury, and pulmonary complications. Local infiltration of liposomal bupivacaine (EXPAREL Pacira Pharmaceuticals, Inc., Parsippany, New Jersey) may provide longer-lasting pain relief when compared to single shot INB (SSINB), and reduce opioid consumption at 24 hours, 48 hours and 72 hours post-op. Studies have shown inconsistency in the effectiveness of EXPAREL, and one proposed reason is the method of administration. Clinicians experienced in their infiltration technique demonstrated greater improvement in pain-related outcomes. The first 48 hours post-op present the most likely opportunity for reducing narcotic administration, which increases the value of attempting to reduce opioid consumption during this period. The cost of EXPAREL LIA, is slightly less than the cost of CINB, and if pain control is comparable, may benefit the patient in reducing hospital costs. The purpose of this study is to examine the effectiveness of pain control of local infiltration of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL | Experimental | Drug: local infiltration of liposomal bupivacaineThose patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue. |
| interscalene nerve block | Active comparator | Other: continuous infusion of ropivacaine interscalene nerve blockPatients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgical candidate for primary total shoulder replacement or reverse total shoulder replacement
- Patient must be 18 years or older
- Patient must be willing and able to sign IRB approved informed consent form, and must be able to understand and agree to follow study protocol.
Key exclusion criteria (12 listed)
- Severe bronchopulmonary disease
- Oxygen dependent
- Existing nerve injury
- BMI > 40
- Coagulation disorders
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 |
|---|---|---|
| local infiltration of liposomal bupivacaineThose patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue. | Drug | EXPAREL |
| continuous infusion of ropivacaine interscalene nerve blockAll patients will receive a single injection of 30mL, 0.5% preservative-free ropivacaine. Those patients randomized to receive CINB will then have an indwelling catheter placed and held in place by Dermabond and Tegaderm. Placement will be confirmed by ultrasound. Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer. | Other | interscalene nerve block |
Primary outcome
Opioid consumption
Time frame: post-operative day 1
Opioid consumption in morphine equivalents within the first 24 hours post-operatively.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Background: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Background: PubMed 20565394Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
- Background: PubMed 9924240Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. Br J Anaesth. 1998 Oct;81(4):603-5. doi: 10.1093/bja/81.4.603.
- Background: PubMed 12170039Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Jun;96(6):1297-304. doi: 10.1097/00000542-200206000-00006.
- Background: PubMed 26276164Bjornholdt KT, Jensen JM, Bendtsen TF, Soballe K, Nikolajsen L. Local infiltration analgesia versus continuous interscalene brachial plexus block for shoulder replacement pain: a randomized clinical trial. Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1245-52. doi: 10.1007/s00590-015-1678-2. Epub 2015 Aug 15.
- Background: PubMed 27422692Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, Kolowich PA, Muh SJ. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg. 2016 Nov;25(11):1742-1748. doi: 10.1016/j.jse.2016.05.007. Epub 2016 Jul 14.
- Background: PubMed 28005096Hannan CV, Albrecht MJ, Petersen SA, Srikumaran U. Liposomal Bupivacaine vs Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Retrospective Cohort Analysis. Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):424-430.
- BackgroundJefferey D. Angel M, Chris A. Steel JR, Devin Ong, PhD, Heather Watson, PhD, Scott T. Lovald, PhD. Pain Control after Total and Reverse Shoulder Arthroplasty: Interscalene Block vs. Liposomal Bupivacaine. In: AAOS Annual Meeting. 2016
- Background: PubMed 22410178Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers. De-identified results will be shared via publication, and conference.
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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 local infiltration of liposomal bupivacaine and continuous infusion of ropivacaine interscalene nerve block in people with Pain, Postoperative and Shoulder Osteoarthritis, run by TriHealth Inc. 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 3 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: withdrawn, as of the sponsor's last update on 1 Mar 2021. 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 withdrawn before enrolling participants, so there are no results.
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: post-operative day 1). 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 NCT03474510, which also lists 9 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 1 Mar 2021.