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The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine 0.25% | Active Comparator | 20 cc of bupivacaine 0.25% |
|
| Liposomal bupivacaine | Experimental | liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block. | Post op Day 1, post op Day 2, post op day 3, post op 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Analgesia | The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain. | Post op Day 1, post op Day 2, post op day 3, post op 1 week |
| Sensory and Motor Block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Shariat, MD | St. Luke's-Roosevelt Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Roosevelt Hospital Center | New York | New York | 10025 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) |
| FG001 | Bupivacaine 0.25% | 20 cc of bupivacaine 0.25% |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) |
| BG001 | Bupivacaine 0.25% | 20 cc of bupivacaine 0.25% |
| 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 | Total Opioid Consumption | Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block. | Posted | Mean | Standard Deviation | number of percocet tabs | Post op Day 1, post op Day 2, post op day 3, post op 1 week |
|
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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 | liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED visit | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ali Shariat | Icahn School of Medicine at Mount Sinai | alishariatmd@gmail.com |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine 0.25% | Drug | 20 cc of bupivacaine 0.25% |
|
|
Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function.
| at 20 min and at 1 hour |
| Time to First Pain Medicine | 72 hours |
| Time to Discharge Home | data not collected | 72 hours |
| Incidence of Postoperative Nausea and Vomiting | 72 hours |
| Sleep Quality | scale of 0-10, 0=horrible, up all night; 10=perfect sleep | Post op Day 1, post op Day 2, post op day 3, post op 1 week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Quality of Analgesia | The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain. | Posted | Mean | Standard Deviation | units on a scale | Post op Day 1, post op Day 2, post op day 3, post op 1 week |
|
|
|
| Secondary | Sensory and Motor Block | Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function. | Posted | Mean | Standard Deviation | units on a scale | at 20 min and at 1 hour |
|
|
|
| Secondary | Time to First Pain Medicine | Posted | Mean | Standard Deviation | minutes | 72 hours |
|
|
|
| Secondary | Time to Discharge Home | data not collected | Posted | 72 hours |
|
|
| Secondary | Incidence of Postoperative Nausea and Vomiting | Posted | Number | percentage of participants | 72 hours |
|
|
|
| Secondary | Sleep Quality | scale of 0-10, 0=horrible, up all night; 10=perfect sleep | Posted | Mean | Standard Deviation | units on a scale | Post op Day 1, post op Day 2, post op day 3, post op 1 week |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Bupivacaine 0.25% | 20 cc of bupivacaine 0.25% | 0 | 19 | 0 | 19 | 1 | 19 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D000588 |
| Amines |
| Post op Day 3 |
|
| Post Op 1 Week |
|
| Sensory block at 1 hour after arrival to PACU |
|
| Post op Day 3 |
|
| Post Op 1 Week |
|