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The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.
This is a prospective, single-blinded randomized clinical trial comparing outcomes in patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine versus standard bupivacaine alone. Once consent is obtained, baseline characteristics will be recorded and patients will be randomized to intervention or control. Following surgery, patients will be followed until their 3-week post-operative visit. The primary outcome measure will be the mean difference in patient pain scores over the first 72 hours post-operatively between two groups. Secondary outcomes will include: (1) Total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks (2) Patient perceived duration of block determined as the time patient perceives complete resolution of block (3) Patient satisfaction with pain control at 72 hours, 3 weeks post-operatively and patient reported outcome measures (SANE, SST, ASES, VR-12) at 3 weeks post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Experimental | Administered utilizing ultrasound guidance by an anesthesiologist. Study patients will receive 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block. |
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| Plain Bupivacaine | Active Comparator | Peripheral nerve blocks will be performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride will be utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block will be utilized. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | Interscalene Nerve Blocks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain Scores | Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain. | 72 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks | Measured at 72 hours and at 3 weeks post-operatively |
| Time to Cessation of Nerve Blockade |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Hattrup | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
| PubMed | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block. Liposomal Bupivacaine: Interscalene Nerve Blocks |
| FG001 | Plain Bupivacaine | Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block. Bupivacaine Hydrochloride: Interscalene Nerve Blocks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block. Liposomal Bupivacaine: Interscalene Nerve Blocks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Pain Scores | Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain. | Posted | Mean | Standard Deviation | score on a scale | 72 hours post-operatively |
|
Adverse events were collected from baseline to treatment follow up visit, approximately 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine | Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block. Liposomal Bupivacaine: Interscalene Nerve Blocks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J. Hattrup, M.D. | Mayo Clinic | 480-301-8519 | hattrup.steven@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2018 | Jan 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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The pharmacist will prepare, and dispense the medication sequentially. Medication syringes will be blinded utilizing black tape. Patients, care team in recovery, study team members collecting and recording data, and statisticians will be blinded to randomization assignment. All patients will be documented in EMR as receiving liposomal bupivacaine to ensure the blind is maintained and to ensure that safety features in the EMR for all patients receiving liposomal bupivacaine are activated. Further, all additional standard precautionary measures (e.g. wrist band) will be similarly implemented for both patient groups.
| Bupivacaine Hydrochloride |
| Drug |
Interscalene Nerve Blocks |
|
Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.
| 4, 8, 12, 16, 20, 24, and 28 hours post-operatively |
| Satisfaction With Pain Control Using Satisfaction Scale | Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management. | Measured at 72 hours and at three weeks post-operatively |
| BG001 | Plain Bupivacaine | Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block. Bupivacaine Hydrochloride: Interscalene Nerve Blocks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Opioid Consumption | Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks | Posted | Mean | Standard Deviation | morphine milligram equivalent (MME) | Measured at 72 hours and at 3 weeks post-operatively |
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| Secondary | Time to Cessation of Nerve Blockade | Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site. | Posted | Count of Participants | Participants | 4, 8, 12, 16, 20, 24, and 28 hours post-operatively |
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| Secondary | Satisfaction With Pain Control Using Satisfaction Scale | Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management. | Posted | Mean | Standard Deviation | units on a scale | Measured at 72 hours and at three weeks post-operatively |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Plain Bupivacaine | Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block. Bupivacaine Hydrochloride: Interscalene Nerve Blocks | 0 | 52 | 0 | 52 | 0 | 52 |
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| D000588 |
| Amines |
| .5800 |
| Superiority |
| 12 hours |
|
| 16 hours |
|
| 20 hours |
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| 24 hours |
|
| 28 hours |
|
| .5327 |
| Superiority |