Chronic Shoulder PainPhase 2/3ETSPNCT03739021
Exparel for Total Shoulder Pain
A Phase 2/3 study testing Exparel and Ropivacaine in people with Chronic Shoulder Pain, run by University of South Florida.
Trial summary
Total shoulder surgery (arthroplasty) is a widely successful method of treating shoulder arthritis. Although the goal of the procedure is pain relief, post-operative pain is unavoidable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- Exparel and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to 15 Nov 2020
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 years or older
- Patients admitted to TGH for total shoulder replacement surgery
- Subjects who have given written informed consent
Who cannot join
- Patients with allergic reactions to Exparel or Ropivacaine
- Female patients who are pregnant
- Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Requirements for Post-operative Pain Control in Total Shoulder Replacement Patients: Comparison of Interscalene Single Shot Exparel (Bupivacaine Liposome) Injections to Cervical Paravertebral Catheter With Ropivacaine (0.2% Continuous Infusion)
Total shoulder surgery (arthroplasty) is a widely successful method of treating shoulder arthritis. Although the goal of the procedure is pain relief, post-operative pain is unavoidable. Pain is a common side effect that many patients undergo while in the clinical setting and is a vital factor in influencing the length of hospital stay, narcotic usage, as well as overall patient satisfaction. Post-operative pain management typically involves elevated usage of narcotics, which is a concern among clinicians and researchers alike. To combat this issue, research is examining intraoperative procedures as a means of reducing post-operative pain scores.
Research has discovered the advantages of utilizing local anesthetic techniques as opposed to just general anesthesia. Local anesthetic blocks function by preventing the generation of nerve impulses by increasing the action-potential threshold, thereby inhibiting movement. Previous studies have demonstrated the success of local anesthetic interscalene blocks across several medical procedures. For instance, Exparel (liposomal bupivacaine) has been effective in reducing post-operative pain scores in tonsillectomy and shoulder arthroplasty. Another local anesthetic, Ropivacaine, has been found to be potent when utilized via a cervical paravertebral catheter among thoracic procedures.
Our study will compare Exparel (bupivacaine liposome) with Ropivacaine continuous infusion for post-operative pain scores in total shoulder surgery patients. Additionally, we will collect data on complications, length of stay, and other variables.
Read the detailed description
Procedure Description:
The investigators commonly use these blocks for patients requiring total shoulder replacement: the patient is usually sedated with propofol. The patient is positioned in the lateral decubitus, or sitting position for this block. After the skin preparation and draping, the fingers of the non-operative hand separate the trapezius and levator scapulae muscle and a 25 gauge needle is used to anesthetize the skin and subcutaneous tissue.
The Trapezius and Levator Scapulae muscles are again separated with the non-operative hand and a 17 or 18 gauge insulated tuohy needle is inserted, which is attached to a nerve stimulator set at a current output of one to three milliamps, a frequency of two Hertz, and a pulse width of 200 to 300 microseconds. The needle is advanced towards the suprasternal notch until contact with the bony structures is made.
After contact with the bone the stylet of the needle is removed, the needle tip is walked off the bony structures in a lateral and slightly superior direction remaining on the plane of the line drawn from the dorsal spine of C6 to the suprasternal notch. After walking off of these bones structures the needle is advanced carefully in an anterior direction. As the needle is advanced there will be a motor response from the stimulator current. The muscles involved are usually the triceps, biceps, deltoids or major pectoral muscle but any muscle group of the upper limb would be acceptable for this block since the needle is now in contact with the posterior aspects of the roots of the brachial plexus. The tip of the needle at this point is situated between the anterior and middle scalene muscles and is in contact with the C6 root of the brachial plexus. At this point either a single-shot injection of Exparel will be performed, or a catheter for Ropivacaine will be inserted, as described below.
For catheter insertion: the nerve stimulator is removed from the needle and attached to the proximal end of the stimulating catheter and the tip of the catheter is inserted into the needle shaft. The nerve stimulator is usually set at a current output of one milliamp. The motor response should be unchanged. The catheter is advanced beyond the needle tip, if the motor response disappears, the catheter is careful drawn into the needle shaft and small adjustment to the needle, advancing slightly or withdrawing it slightly is done. This maneuver is repeated until the muscle twitch is unchanged during catheter advance. This indicates the catheter tip is now situated on the nerve root; the catheter is advanced 3 to 5 centimeter beyond the needle tip but not further than 5 centimeters. The needle is then removed without disturbing the catheter and the inner stylet of the catheter is also removed. The catheter position can be confirmed by attaching the nerve stimulator to the catheter, the motor response should be unchanged. The catheter is then subcutaneously tunneled and continuous infusion of Ropivacaine is inserted.
Intraoperative Management:
The intraoperative course will follow the standard of care practices. Doses/concentration of medications/agents used for the anesthetic management of the subjects enrolled in this trial may be adjusted when necessary to provide optimal subject care. Anesthesia will be induced with propofol, intravenous opioids, and other medication(s)/agent(s) at a concentration range/dose(s) based on the clinical need of the subject. Patient will be given succinylcholine to aid in intubation.
Anesthesia will be maintained in both groups with intravenous opioids, propofol and /or medication(s)/agent(s), including inhalation anesthetic agents, at a concentration range/dose(s) based on the clinical need of the subject.
Tracheal extubation will be performed at the end of anesthesia at which point the patient will be discharged to the post-anesthesia care unit.
Postoperative Management:
Upon arrival in the PACU, the (sub)investigator, using the visual analog scale, will clinically assess post-operative pain.
Assessment of patient pain levels involve a series of VAS testing postoperatively (upon arrival and every 30 minutes postoperatively until discharge from the PACU) using a 10 cm line. Patients that complain of pain intensity >5 cm/10 cm, will be given a standardized rescue intravenous dilaudid regimen, IV dilaudid at 0.4mg up to a max dose of 2mg prn q 2 hours or until a VAS of <5 is obtained. If a VAS score of <5 cannot be obtained, the PI may withdraw the patient from the study and administer another pain medication. Post-operative PACU narcotic consumption will be recorded and quantified.
All patients will be monitored with continuous pulse-oximetry. All post-operative complications will be captured.
Follow-up Period: All patients will have a planned hospital admission from the PACU. Pain will be assessed every 2 hours for the first 24 hours followed by every 4 hours until hospital discharge using the VAS scale. All post-operative complications will be captured. Post-PACU narcotic consumption will be recorded and quantified for the first 72 hours after PACU discharge.
- Conditions
- Chronic Shoulder Pain
- Being tested
- Exparel, Ropivacaine
- Keywords
- replacement, shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Single shot of the Bupivacaine Liposome, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected.
RopivacaineDrug
Continuous infusion of Ropivacaine via catheter, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (30 participants) | Experimental | Not described Receives: Drug: Exparel |
| Group 2 (30 participants) | Experimental | Not described Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Surgery (in minutes)
Measured: Intraoperative
Post-Operative VAS Scores (10 cm scale)
Measured: 1 hour after surgery
Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)
Measured: Intraoperative
Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)
Measured: through study completion, 8 months-1 year (on average)
Post-Operative Narcotics Usage during PACU Stay (in Milligrams Morphine Equivalent; MME)
Measured: through study completion, 8 months-1 year (on average)
Post-Operative Narcotics Usage during first 72 hours after PACU discharge (Milligrams in Morphine Equivalents
Measured: First 72 hours after PACU discharge
Length of Hospital Stay (in hours)
Measured: through study completion, 8 months-1 year (on average)
Secondary outcomes (2)
Time spent Nerve Block Procedure (in minutes)
Measured: Intraoperative
Cost of Adjuvant Therapy (in United States Dollar)
Measured: through study completion, 8 months-1 year (on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study startNov 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion15 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Shoulder 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, open label study. A series of 60 sealed envelopes: 30 "Exparel single shot" and 30 "Ropivacaine catheter" will be blindly open for each of the 60 patients when collecting informed consent.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739021
- Sponsor's protocol ID
- 37089
- Acronym
- ETSP
- Status last verified
- May 2019
- First submitted
- 13 Sep 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The original records will be kept confidential. However, we will share the results of our study after removing individual identifiers.
Publications
Olson MD, Moore EJ, Price DL. A Randomized Single-Blinded Trial of Posttonsillectomy Liposomal Bupivacaine among Adult Patients. Otolaryngol Head Neck Surg. 2018 Nov;159(5):835-842. doi: 10.1177/0194599818791773. Epub 2018 Jul 31.
PubMed 30060719
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Requirements for Post-operative Pain Control in Total Shoulder Replacement Patients: Comparison of Interscalene Single Shot Exparel (Bupivacaine Liposome) Injections to Cervical Paravertebral Catheter With Ropivacaine (0.2% Continuous Infusion)
- ClinicalTrials.gov ID
- NCT03739021
- Acronym / sponsor ID
- ETSP / 37089
- Conditions
- Chronic Shoulder Pain
- Keywords
- replacement, shoulder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- Nov 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 15 Nov 2020 (estimated)
- First posted
- 13 Nov 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.
Total shoulder surgery (arthroplasty) is a widely successful method of treating shoulder arthritis. Although the goal of the procedure is pain relief, post-operative pain is unavoidable. Pain is a common side effect that many patients undergo while in the clinical setting and is a vital factor in influencing the length of hospital stay, narcotic usage, as well as overall patient satisfaction. Post-operative pain management typically involves elevated usage of narcotics, which is a concern among clinicians and researchers alike. To combat this issue, research is examining intraoperative procedures as a means of reducing post-operative pain scores.
Research has discovered the advantages of utilizing local anesthetic techniques as opposed to just general anesthesia. Local anesthetic blocks function by preventing the generation of nerve impulses by increasing the action-potential threshold, thereby inhibiting movement. Previous studies have demonstrated the success of local anesthetic interscalene blocks across several medical procedures. For instance, Exparel (liposomal bupivacaine) has been effective in reducing post-operative pain scores in tonsillectomy and shoulder arthroplasty. Another local anesthetic, Ropivacaine, has been found to be potent when utilized via a cervical paravertebral catheter among thoracic procedures.
Our study will compare Exparel (bupivacaine liposome) with Ropivacaine continuous infusion for post-operative pain scores in total shoulder surgery patients. Additionally, we will collect data on complications, length of stay, and other variables.
Detailed description
Procedure Description:
The investigators commonly use these blocks for patients requiring total shoulder replacement: the patient is usually sedated with propofol. The patient is positioned in the lateral decubitus, or sitting position for this block. After the skin preparation and draping, the fingers of the non-operative hand separate the trapezius and levator scapulae muscle and a 25 gauge needle is used to anesthetize the skin and subcutaneous tissue.
The Trapezius and Levator Scapulae muscles are again separated with the non-operative hand and a 17 or 18 gauge insulated tuohy needle is inserted, which is attached to a nerve stimulator set at a current output of one to three milliamps, a frequency of two Hertz, and a pulse width of 200 to 300 microseconds. The needle is advanced towards the suprasternal notch until contact with the bony structures is made.
After contact with the bone the stylet of the needle is removed, the needle tip is walked off the bony structures in a lateral and slightly superior direction remaining on the plane of the line drawn from the dorsal spine of C6 to the suprasternal notch. After walking off of these bones structures the needle is advanced carefully in an anterior direction. As the needle is advanced there will be a motor response from the stimulator current. The muscles involved are usually the triceps, biceps, deltoids or major pectoral muscle but any muscle group of the upper limb would be acceptable for this block since the needle is now in contact with the posterior aspects of the roots of the brachial plexus. The tip of the needle at this point is situated between the anterior and middle scalene muscles and is in contact with the C6 root of the brachial plexus. At this point either a single-shot injection of Exparel will be performed, or a catheter for Ropivacaine will be inserted, as described below.
For catheter insertion: the nerve stimulator is removed from the needle and attached to the proximal end of the stimulating catheter and the tip of the catheter is inserted into the needle shaft. The nerve stimulator is usually set at a current output of one milliamp. The motor response should be unchanged. The catheter is advanced beyond the needle tip, if the motor response disappears, the catheter is careful drawn into the needle shaft and small adjustment to the needle, advancing slightly or withdrawing it slightly is done. This maneuver is repeated until the muscle twitch is unchanged during catheter advance. This indicates the catheter tip is now situated on the nerve root; the catheter is advanced 3 to 5 centimeter beyond the needle tip but not further than 5 centimeters. The needle is then removed without disturbing the catheter and the inner stylet of the catheter is also removed. The catheter position can be confirmed by attaching the nerve stimulator to the catheter, the motor response should be unchanged. The catheter is then subcutaneously tunneled and continuous infusion of Ropivacaine is inserted.
Intraoperative Management:
The intraoperative course will follow the standard of care practices. Doses/concentration of medications/agents used for the anesthetic management of the subjects enrolled in this trial may be adjusted when necessary to provide optimal subject care. Anesthesia will be induced with propofol, intravenous opioids, and other medication(s)/agent(s) at a concentration range/dose(s) based on the clinical need of the subject. Patient will be given succinylcholine to aid in intubation.
Anesthesia will be maintained in both groups with intravenous opioids, propofol and /or medication(s)/agent(s), including inhalation anesthetic agents, at a concentration range/dose(s) based on the clinical need of the subject.
Tracheal extubation will be performed at the end of anesthesia at which point the patient will be discharged to the post-anesthesia care unit.
Postoperative Management:
Upon arrival in the PACU, the (sub)investigator, using the visual analog scale, will clinically assess post-operative pain.
Assessment of patient pain levels involve a series of VAS testing postoperatively (upon arrival and every 30 minutes postoperatively until discharge from the PACU) using a 10 cm line. Patients that complain of pain intensity >5 cm/10 cm, will be given a standardized rescue intravenous dilaudid regimen, IV dilaudid at 0.4mg up to a max dose of 2mg prn q 2 hours or until a VAS of <5 is obtained. If a VAS score of <5 cannot be obtained, the PI may withdraw the patient from the study and administer another pain medication. Post-operative PACU narcotic consumption will be recorded and quantified.
All patients will be monitored with continuous pulse-oximetry. All post-operative complications will be captured.
Follow-up Period: All patients will have a planned hospital admission from the PACU. Pain will be assessed every 2 hours for the first 24 hours followed by every 4 hours until hospital discharge using the VAS scale. All post-operative complications will be captured. Post-PACU narcotic consumption will be recorded and quantified for the first 72 hours after PACU discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open label study. A series of 60 sealed envelopes: 30 "Exparel single shot" and 30 "Ropivacaine catheter" will be blindly open for each of the 60 patients when collecting informed consent.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (30 participants) | Experimental | Drug: Exparel |
| Group 2 (30 participants) | Experimental | Drug: Ropivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years or older
- Patients admitted to TGH for total shoulder replacement surgery
- Subjects who have given written informed consent
Key exclusion criteria (3 listed)
- Patients with allergic reactions to Exparel or Ropivacaine
- Female patients who are pregnant
- Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
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 |
|---|---|---|
| ExparelSingle shot of the Bupivacaine Liposome, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected. | Drug | Group 1 (30 participants) |
| RopivacaineContinuous infusion of Ropivacaine via catheter, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected. | Drug | Group 2 (30 participants) |
Primary outcome
Duration of Surgery (in minutes)
Time frame: Intraoperative
Post-Operative VAS Scores (10 cm scale)
Time frame: 1 hour after surgery
Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)
Time frame: Intraoperative
Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)
Time frame: through study completion, 8 months-1 year (on average)
Post-Operative Narcotics Usage during PACU Stay (in Milligrams Morphine Equivalent; MME)
Time frame: through study completion, 8 months-1 year (on average)
Post-Operative Narcotics Usage during first 72 hours after PACU discharge (Milligrams in Morphine Equivalents
Time frame: First 72 hours after PACU discharge
Length of Hospital Stay (in hours)
Time frame: through study completion, 8 months-1 year (on average)
2 secondary outcomes
Time spent Nerve Block Procedure (in minutes)
Time frame: Intraoperative
Cost of Adjuvant Therapy (in United States Dollar)
Time frame: through study completion, 8 months-1 year (on average)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 30060719Olson MD, Moore EJ, Price DL. A Randomized Single-Blinded Trial of Posttonsillectomy Liposomal Bupivacaine among Adult Patients. Otolaryngol Head Neck Surg. 2018 Nov;159(5):835-842. doi: 10.1177/0194599818791773. Epub 2018 Jul 31.
- Individual participant dataSharing planned: Yes. The original records will be kept confidential. However, we will share the results of our study after removing individual identifiers.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exparel and Ropivacaine in people with Chronic Shoulder Pain, run by University of South Florida.
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 3 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: opening soon, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico M Camporesi, MD (8136009094, ecampore@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Surgery (in minutes) (time frame: Intraoperative). The study lists 7 primary outcomes in all. 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 NCT03739021, which also lists 1 linked publication.
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 16 Jul 2019.