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| Name | Class |
|---|---|
| American Society of Regional Anesthesia | OTHER |
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The goal of this clinical trial is to learn whether a phrenic-sparing nerve block can lower early breathing problems after shoulder surgery in adults with obesity, and whether a simple breathing-strength test (maximum inspiratory pressure, MIP) helps identify who is at higher risk. The main questions are:
Does the phrenic-sparing approach reduce breathlessness or oxygen need in the recovery room (30-60 minutes after arrival)? Do patients have similar pain control and opioid use compared with the standard interscalene block (ISB)? Are there any breathing-related complications or unplanned admissions within 24 hours? Researchers will compare the phrenic-sparing block (infraclavicular + distal suprascapular) to the standard ISB, both commonly used at UNC.
Participants will:
Have a quick MIP breath test before surgery (and, if age ≥65, a brief thigh muscle ultrasound).
Be randomly assigned to receive either the standard ISB or the phrenic-sparing block (both ultrasound-guided and part of routine care).
Receive usual anesthesia/surgery; have a brief recovery check at 30-60 minutes (breathlessness score, oxygen use, oxygen level).
Have pain medicines recorded from anesthesia start to PACU discharge; the team may review the chart up to 24 hours and make a short follow-up call (24-48 hours).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Standard Interscalene Block | Active Comparator | Standard Interscalene Brachial Plexus Block (Control) Description: Participants receive a single 16 mL interscalene block at the C5-C6 level under ultrasound guidance. The injectate contains 15 mL of 0.5% bupivacaine HCl (75 mg) mixed with 1 mL preservative-free dexamethasone (4 mg). |
|
| Arm 2: Phrenic-Sparing Block Combination | Experimental | Combined Infraclavicular + Distal Suprascapular Block (Phrenic-Sparing Technique) Description: Participants receive two ultrasound-guided peripheral nerve blocks designed to minimize phrenic nerve involvement: Infraclavicular block: 15 mL 0.5% bupivacaine + 1 mL dexamethasone (total 16 mL) Distal suprascapular block: 12 mL 0.5% bupivacaine + 1 mL dexamethasone (total 13 mL) Total local-anesthetic dose = 135 mg bupivacaine + 8 mg dexamethasone, within accepted safety limits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-Guided Interscalene Brachial Plexus Block | Procedure | Single 16 mL injection (15 mL 0.5 % bupivacaine + 1 mL dexamethasone 4 mg) at the C5-C6 root level under ultrasound guidance. Performed pre-operatively as standard care for shoulder surgery. Arm Cross-Reference: Standard Interscalene Block (Control) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Early Postoperative Respiratory Compromise | Composite outcome defined as either (a) a Modified Borg Dyspnea Score ≥ 3 in the post-anesthesia care unit (PACU, 30-60 minutes after surgery) or (b) continued need for supplemental oxygen at the PACU assessment. Outcome Type: Primary Unit of Measure: Percentage of participants meeting composite endpoint. | Within 60 minutes after arrival to PACU |
| Effect Modification by Preoperative Maximum Inspiratory Pressure (MIP) | Assess whether the magnitude of treatment benefit from the phrenic-sparing block varies by baseline inspiratory-muscle strength. The effect is modeled as the interaction between block type and continuous MIP (cm Hâ‚‚O) on the composite respiratory-compromise endpoint. Unit of Measure: Interaction odds ratio (per 10 cm Hâ‚‚O decrement in MIP). | Baseline (preoperative MIP test) and PACU assessment (30-60 minutes post-surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest Oxygen Saturation (SpOâ‚‚) in PACU | Minimum oxygen saturation recorded by pulse oximetry during the PACU stay Unit of Measure: Percent (%) | From PACU arrival to discharge (typically 60-120 minutes) |
| Total Duration of Supplemental Oxygen Use |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Association of Frailty and Sarcopenia Measures With Respiratory Outcomes | Explore whether rectus femoris index (cm/height²) or Clinical Frailty Scale (CFS) scores predict postoperative respiratory compromise in participants ≥ 65 years. Unit of Measure: Correlation coefficient or adjusted risk ratio. | Baseline preoperative assessment; outcome analyzed at PACU. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monika Nanda | Contact | 919-966-5136 | mnanda@aims.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Monika Nanda | University of North Carollina at Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Hospitals | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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beginning 9 and continuing for 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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|
| Phrenic-Sparing Block Combination (Experimental) | Procedure | Infraclavicular: 15 mL (75 mg) 0.5 % bupivacaine + 1 mL dexamethasone (4 mg) injected around the cords of the brachial plexus beneath the clavicle under ultrasound guidance. Distal Suprascapular: 12 mL (60 mg) 0.5 % bupivacaine + 1 mL (4 mg) dexamethasone injected at the suprascapular notch under ultrasound guidance to provide complete shoulder coverage while minimizing phrenic nerve involvement. Total local anesthetic dose = 135 mg bupivacaine + 8 mg dexamethasone. Arm Cross-Reference: Phrenic-Sparing Block Combination (Experimental) |
|
| Bupivacaine HCl 0.5% Injectable Solution | Drug | Infraclavicular: Adminstered as 15 mL (75 mg) injection (together with dexamethasone). Distal Suprascapular: Adminstered as 12 mL (60 mg) injection (together with dexamethasone). |
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| Dexamethasone 4mg | Drug | Adminstered as applicable for infraclavicular and distal suprascapular: as 1 mL (4 mg) injection (together with bupicacaine 0.5%). |
|
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Total number of hours on oxygen from PACU arrival until hospital discharge (maximum 24 hours).
Unit of Measure: Hours.
| 0-24 hours post-surgery. |
| Post-Induction Opioid Consumption | Total opioid dose administered from anesthesia induction to PACU discharge, converted to oral morphine milligram equivalents (OMME). Unit of Measure: mg OMME. | 0-6 hours post-surgery. |
| Diaphragmatic Excursion Change from Baseline | Percent change in diaphragmatic excursion (ultrasound-measured) from baseline to PACU. Unit of Measure: Percent change (%). | Baseline (pre-block) and 30-60 minutes post-surgery in PACU. |
| PACU Pain Score | Numeric Rating Scale (NRS) for pain recorded at 30-60 minutes post-surgery. Unit of Measure: 0-10 NRS scale. | Within 1 hour after PACU arrival. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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