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This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.
This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking ASA 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third group receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist). Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound. Secondary outcomes include incidence of hemidiaphragmatic paralysis as measured by point of care ultrasound (POCUS) in the immediate postoperative period, postoperative day (POD) 1, POD2, and POD3 and noninvasive measures of pulmonary gas exchange at pre-op, post-op, POD1, POD2, and POD3. Additionally, the investigators will look at pain scores (scale of 0-10) and opioid consumption (in oral morphine equivalents) at previously defined time points listed above. Furthermore, the investigators will record known side effects of interscalene blocks including hoarseness and Horner's syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Perineural Catheter | Placement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion. |
| |
| 10 mL Liposomal Bupivacaine Single Shot | Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine |
| |
| 20 mL Liposomal Bupivacaine Single Shot | Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Diagnostic Test | Ultrasound guided evaluation of diaphragm ipsilateral to the block side. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1 | Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3 | Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3 | up to 72 hours |
| Noninvasive pulmonary measures of gas exchange |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ages 18-80 undergoing shoulder surgery per standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WIlliam M Bullock, MD, PhD | Contact | 919-681-6437 | william.bullock@duke.edu | |
| Amanda Kumar, MD | Contact | 919-681-6437 | amanda.kumar@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amanda Kumar, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Recruiting | Durham | North Carolina | 27710 | United States |
Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used once patient has completed the study.
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| Ropivacaine | Drug | Local anesthetic (numbing drug) |
|
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| Bupivacaine | Drug | Local anesthetic (numbing drug) |
|
|
| MediPines AGM100 Advanced Respiratory Monitoring System | Device | Non-invasive respiratory monitor to measure oxygenation and ventilation parameters |
|
|
Noninvasive pulmonary measures of gas exchange
| up to 72 hours |
| Pain scores | Numerical Rating Scale (NRS) 11 pain scores (0-10; 0=no pain, 10=worst pain ever) at Post Anesthesia Care Unit (PACU), POD1, POD2, POD3 | up to 72 hours |
| Opioid consumption | Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3 | up to 72 hours |
| Hoarseness | Incidence of recurrent laryngeal nerve palsy (subjective) | up to 72 hours |
| Horner's Syndrome | Incidence of Horner's Syndrome | up to 72 hours |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D000070599 | Shoulder Injuries |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D012421 | Rupture |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D000077212 | Ropivacaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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