PainPhase 4EXP-TSANCT02570022
Liposomal Bupivacaine in Total Shoulder Arthroplasty
A Phase 4 study testing Liposomal bupivacaine, Inter-scalene nerve block and Ropivacaine in people with Pain, run by Henry Ford Health System at 1 site in United States.
Trial summary
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares pain control and opioid consumption in patients undergoing shoulder arthroplasty between patients receiving liposomal bupivacaine and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Liposomal bupivacaine, Inter-scalene nerve block and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 over the age of 18 scheduled for primary shoulder arthroplasty by three fellowship trained surgeons will be eligible for inclusion
Who cannot join
- Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liposomal Bupivacaine Versus Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Prospective Randomized Trial
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares pain control and opioid consumption in patients undergoing shoulder arthroplasty between patients receiving liposomal bupivacaine and those who underwent a preoperative inter-scalene nerve block.
Read the detailed description
Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All patients over age eighteen and scheduled for primary shoulder arthroplasty (SA) a three fellowship trained surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy.
Liposomal Bupivacaine has a refrigerated shelf life of one month the investigational facility. Patients will be sequentially recruited into the randomization process. Liposomal Bupivacaine will be held by the Henry Ford hospital pharmacy up to one month prior to planned shoulder arthroplasty in anticipation of surgery on eligible patients. The sterile solutions will be delivered to and kept by the inpatient clinical pharmacy until the date of surgery and delivered to the operating room at the beginning of a surgical case. The current dose of Liposomal Bupivacaine has been chosen based on previously published data of local infiltrative analgesia with Liposomal Bupivacaine and one published study on Liposomal Bupivacaine efficacy.
The week prior to surgery, patients will be randomized to receive Local infiltration anesthesia (LIA) with Liposomal Bupivacaine, or Inter-scalene nerve block (INB) using a computer generated sequence. The results of randomization will be securely delivered to the anesthesiologist and the surgeon the week prior. The anesthesiologist will view the assigned group to determine if a preoperative INB will be given. Depending on the randomization group either an Liposomal Bupivacaine solution will be delivered to the operating room for local infiltration or the anesthesiologist will perform a preoperative INB.
Patients in the Liposomal Bupivacaine group will receive LIA with 10cc(133mg) of Liposomal Bupivacaine solution dissolved in 20cc of sterile saline before wound closure. The solution will be applied to the wound bed, muscles, and periosteum. The solution will be left unperturbed for five minutes. Thereafter the solution will be suctioned from the wound and the shoulder joint. Incisions will be closed in typical fashion and the wound dressed.The tourniquet will be deflated.
Patients in the INB will receive postoperative ultrasound guided INB. Experienced anesthesiologists will apply all INBs in this study.
Following the procedure pain will be accessed subjectively through visual analog scale and numeric rating scale pain scores, pain diaries given to the patient to record at home, pain summary scores at follow up visits and objectively through narcotic pain requirement. A blind observer will also access outcomes.
Planned Data Analysis:
Means and standard deviations, as well as medians and interquartile ranges will be computed for pain scores.These outcomes will be compared by Wilcoxon rank sum tests. The amount of pain medication and pain scores will be compared by Wilcoxon rank sum tests.
- Conditions
- Pain
- Being tested
- Liposomal bupivacaine, Inter-scalene nerve block, Ropivacaine
- Keywords
- Pain control, liposomal bupivacaine, exparel, shoulder arthroplasty
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called exparel
Local infiltration of liposomal bupivacaine
Inter-scalene nerve blockProcedure or surgery
Also called Naropin
Pre-operative inter-scalene nerve block
RopivacaineDrug
Ropivicaine was used for the inter-scalene nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine | Experimental | Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. Receives: Drug: Liposomal bupivacaine |
| Inter-scalene nerve block | Active comparator | Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine. Receives: Procedure: Inter-scalene nerve block; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels
Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.
Measured: four days postoperatively
Secondary outcomes (1)
Morphine Equivalents
Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.
Measured: four days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelechi Okoroha, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570022
- Sponsor's protocol ID
- LB-TSA
- Acronym
- EXP-TSA
- Status last verified
- Aug 2016
- First submitted
- 5 Oct 2015
- Last updated
- 13 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine Versus Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02570022
- Acronym / sponsor ID
- EXP-TSA / LB-TSA
- Conditions
- Pain
- Keywords
- Pain control, liposomal bupivacaine, exparel, shoulder arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 13 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares pain control and opioid consumption in patients undergoing shoulder arthroplasty between patients receiving liposomal bupivacaine and those who underwent a preoperative inter-scalene nerve block.
Detailed description
Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All patients over age eighteen and scheduled for primary shoulder arthroplasty (SA) a three fellowship trained surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy.
Liposomal Bupivacaine has a refrigerated shelf life of one month the investigational facility. Patients will be sequentially recruited into the randomization process. Liposomal Bupivacaine will be held by the Henry Ford hospital pharmacy up to one month prior to planned shoulder arthroplasty in anticipation of surgery on eligible patients. The sterile solutions will be delivered to and kept by the inpatient clinical pharmacy until the date of surgery and delivered to the operating room at the beginning of a surgical case. The current dose of Liposomal Bupivacaine has been chosen based on previously published data of local infiltrative analgesia with Liposomal Bupivacaine and one published study on Liposomal Bupivacaine efficacy.
The week prior to surgery, patients will be randomized to receive Local infiltration anesthesia (LIA) with Liposomal Bupivacaine, or Inter-scalene nerve block (INB) using a computer generated sequence. The results of randomization will be securely delivered to the anesthesiologist and the surgeon the week prior. The anesthesiologist will view the assigned group to determine if a preoperative INB will be given. Depending on the randomization group either an Liposomal Bupivacaine solution will be delivered to the operating room for local infiltration or the anesthesiologist will perform a preoperative INB.
Patients in the Liposomal Bupivacaine group will receive LIA with 10cc(133mg) of Liposomal Bupivacaine solution dissolved in 20cc of sterile saline before wound closure. The solution will be applied to the wound bed, muscles, and periosteum. The solution will be left unperturbed for five minutes. Thereafter the solution will be suctioned from the wound and the shoulder joint. Incisions will be closed in typical fashion and the wound dressed.The tourniquet will be deflated.
Patients in the INB will receive postoperative ultrasound guided INB. Experienced anesthesiologists will apply all INBs in this study.
Following the procedure pain will be accessed subjectively through visual analog scale and numeric rating scale pain scores, pain diaries given to the patient to record at home, pain summary scores at follow up visits and objectively through narcotic pain requirement. A blind observer will also access outcomes.
Planned Data Analysis:
Means and standard deviations, as well as medians and interquartile ranges will be computed for pain scores.These outcomes will be compared by Wilcoxon rank sum tests. The amount of pain medication and pain scores will be compared by Wilcoxon rank sum tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine | Experimental | Drug: Liposomal bupivacainePatients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. |
| Inter-scalene nerve block | Active comparator | Procedure: Inter-scalene nerve block, Drug: RopivacainePatients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 scheduled for primary shoulder arthroplasty by three fellowship trained surgeons will be eligible for inclusion
Key exclusion criteria (1 listed)
- Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: exparelLocal infiltration of liposomal bupivacaine | Drug | Liposomal bupivacaine |
| Inter-scalene nerve blockAlso: NaropinPre-operative inter-scalene nerve block | Procedure or surgery | Inter-scalene nerve block |
| RopivacaineRopivicaine was used for the inter-scalene nerve block. | Drug | Inter-scalene nerve block |
Primary outcome
Pain Levels
Time frame: four days postoperatively
Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.
1 secondary outcome
Morphine Equivalents
Time frame: four days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Liposomal bupivacaine, Inter-scalene nerve block and Ropivacaine in people with Pain, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 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 13 Oct 2016. 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?
Yes. Results are posted in the registry (first posted 13 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Levels (time frame: four days postoperatively). 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 13 Oct 2016.