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Patients pain was not regulated well with this product.
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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.
Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting this study, will allow the option for a surgeon to administer a local anesthetic, in a single injection, to the exact location of the surgical procedure and in a sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used as a safe alternative to current post-operative pain control methods, while limiting narcotic use and providing appropriate postoperative analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPAREL 1.3 % in 20 ML Injection | Other | EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL 1.3 % in 20 ML Injection | Drug | EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS Pain Score | Patient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe) | 12 hours, 24 hours, 36 hours, 48 hours |
| Narcotic Medication Usage | Number of narcotic medication tablets consumed | 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm | American Shoulder and Elbow Surgeons Shoulder Score (ASES) of surgical arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function) | 2 weeks |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James R Andrews, MD | Andrews Institute for Orthopaedics & Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews Research & Education Foundation | Gulf Breeze | Florida | 32561 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2131867 | Background | Johnson MD, Mickler T, Arthur GR, Rosenburg S, Wilson R. Bupivacaine with and without epinephrine for intercostal nerve block. J Cardiothorac Anesth. 1990 Apr;4(2):200-3. doi: 10.1016/0888-6296(90)90238-b. | |
| 16088895 | Background | Colombo G, Padera R, Langer R, Kohane DS. Prolonged duration local anesthesia with lipid-protein-sugar particles containing bupivacaine and dexamethasone. J Biomed Mater Res A. 2005 Nov 1;75(2):458-64. doi: 10.1002/jbm.a.30443. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EXPAREL 1.3 % in 20 ML Injection | EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EXPAREL 1.3 % in 20 ML Injection | EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | VAS Pain Score | Patient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe) | Posted | Mean | Standard Deviation | units on a scale | 12 hours, 24 hours, 36 hours, 48 hours |
|
10 months
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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 | EXPAREL 1.3 % in 20 ML Injection | EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Truett | Andrews Research and Education Foundation | 8509168570 | jessica.truett@andrewsref.org |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of healthy (nonsurgical) arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function) |
| 2 weeks |
| 22266897 | Background | Bergese SD, Onel E, Morren M, Morganroth J. Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):145-51. doi: 10.1097/AAP.0b013e31823d0a80. |
| 24817851 | Background | Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014 Apr 30;5:90. doi: 10.3389/fphar.2014.00090. eCollection 2014. |
| 22956491 | Background | Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):19S-26S. doi: 10.1002/j.1875-9114.2012.01183.x. |
| 25018650 | Background | Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014. |
| 24793570 | Background | Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4. |
| 15271745 | Background | Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49. |
| 11605927 | Background | Borgeat A, Ekatodramis G, Kalberer F, Benz C. Acute and nonacute complications associated with interscalene block and shoulder surgery: a prospective study. Anesthesiology. 2001 Oct;95(4):875-80. doi: 10.1097/00000542-200110000-00015. |
| 19604186 | Background | Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x. |
| 21148659 | Background | Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273. |
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Narcotic Medication Usage | Number of narcotic medication tablets consumed | Posted | Mean | Standard Deviation | quantity of tablets | 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days |
|
|
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| Secondary | American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm | American Shoulder and Elbow Surgeons Shoulder Score (ASES) of surgical arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function) | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm | American Shoulder and Elbow Surgeons Shoulder Score (ASES) of healthy (nonsurgical) arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function) | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| Title | Measurements |
|---|---|
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| 48 Hours |
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| Day 3 |
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| Day 7 |
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| Day 14 |
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