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| Name | Class |
|---|---|
| New York School of Regional Anesthesia | OTHER |
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.
The interscalene brachial plexus block (ISBPB) is a common analgesic technique for procedures of the shoulder and upper arm.
Moreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. Continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.This study is designed to compare the level and duration of pain control of Exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for ISBPB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel block in arthroscopic surgery | Experimental | Evaluation of Exparel block in arthroscopic shoulder surgery. |
|
| Bupivacaine block in shoulder surgery | Experimental | Evaluation of Bupivacaine block in shoulder surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel block in arthroscopic shoulder surgery | Drug | The interscalene block will be performed with ultrasound guidance and nerve stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Worst pain | assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7 | |
| Satisfaction with analgesia | assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7 |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of sensory block | onset will be measured up to 30 minutes | |
| Duration of sensory block | duration will be measured up to 72 hours | |
| Onset of motor block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Admir Hadzic, MD | Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology Ziekenhuis Oost-Limburg | Genk | Belgium | ||||
| Department of Anesthesiology ZOL |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28157791 | Derived | Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560. |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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 block in shoulder surgery | Drug | The interscalene block will be performed with ultrasound guidance and nerve stimulation. |
|
|
| onset will be measured up to 30 minutes |
| duration of motor block | duration will be measured up to 72 hours |
| functionality of the surgical arm | assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7 |
| Genk |
| Belgium |
| D000588 |
| Amines |