Shoulder SurgeryNCT07216820
Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure
A study testing Ultrasound-Guided Interscalene Brachial Plexus Block, Phrenic-Sparing Block Combination (Experimental) and Bupivacaine HCl 0.5% Injectable Solution in people with Shoulder Surgery and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Surgery, Obesity
- What is being tested?
- Ultrasound-Guided Interscalene Brachial Plexus Block, Phrenic-Sparing Block Combination (Experimental) and Bupivacaine HCl 0.5% Injectable Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2026to 15 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years (self-report, confirmed on chart).
- Body-mass index ≥ 35 kg m^2 at the pre-operative clinic visit (chart).
- Scheduled for elective unilateral shoulder surgery (arthroscopy, arthroplasty, rotator cuff repair, reverse arthroplasty) under general anesthesia at UNC Hospitals
- Planned use of a single-injection regional brachial-plexus block for postoperative analgesia (anesthesia record).
- Able to perform a maximal-inspiratory-pressure (MIP) maneuver at screening, producing two reproducible efforts (bedside test)
- Able to read or understand English and provide written informed consent (consent discussion).
Who cannot join
- Emergent or trauma shoulder procedure or case converted to open surgery (schedule/chart).
- Pregnancy confirmed by point-of-care urine test on day of surgery (POC test). Prisoner status or legal incapacity to consent (chart/interview).
- Severe pulmonary disease: GOLD stage 3-4 COPD, restrictive lung disease unrelated to obesity with FVC < 50 % predicted, baseline dyspnea Borg ≥ 3, or home oxygen therapy (pulmonary clinic notes, patient interview).
- Severe heart disease- Severe valvular heart disease, Congestive Heart Failure NYHA Class III or IV, Obstructive Coronary Artery Disease with Angina
- Neuromuscular disorders affecting respiratory muscles (e.g., ALS, myasthenia gravis) or known diaphragmatic paralysis (chart).
- Coagulopathy (platelets < 100 × 10/ L or INR > 1.5) or local infection at block sites (pre-op labs/assessment).
Show all 11Show fewer
- Anemia and hemoglobinopathies: Hgb <10 g/dl, clinically significant hemoglobinopathy.
- Allergy to bupivacaine, dexamethasone, or ultrasound gel (self-report).
- Chronic opioid use > 100 mg oral-morphine equivalents per day in the three months preceding surgery (medication history, PDMP query).
- Prior enrolment in this trial or planned participation in another interventional study that might confound outcomes (research registry).
- Anticipated inability to comply with postoperative assessments (e.g., profound cognitive impairment, expected early transfer to outside facility) as judged by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
Monika Nanda, 919-966-5136, mnanda@aims.unc.edu
About this study
Official title: Interscalene vs Phrenic-sparing Blocks in Obesity: Effect of Pre-operative Maximum Inspiratory Pressure in a Randomized Trial
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.
Read more
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).
- Conditions
- Shoulder Surgery, Obesity
- Being tested
- Ultrasound-Guided Interscalene Brachial Plexus Block, Phrenic-Sparing Block Combination (Experimental), Bupivacaine HCl 0.5% Injectable Solution, Dexamethasone 4mg
- Keywords
- interscalene block, phrenic-sparing block, brachial plexus block
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Interscalene Brachial Plexus BlockProcedure or surgery
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)
Phrenic-Sparing Block Combination (Experimental)Procedure or surgery
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 SolutionDrug
Also called Bupivacaine Hydrochloride Injection
Infraclavicular: Adminstered as 15 mL (75 mg) injection (together with dexamethasone).
Distal Suprascapular: Adminstered as 12 mL (60 mg) injection (together with dexamethasone).
Dexamethasone 4mgDrug
Also called Decadron, Dexamethasone Intensol, De-Sone LA, Dxevo, Dexacorten
Adminstered as applicable for infraclavicular and distal suprascapular: as 1 mL (4 mg) injection (together with bupicacaine 0.5%).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Ultrasound-Guided Interscalene Brachial Plexus Block; Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Dexamethasone 4mg |
| 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. Receives: Procedure: Phrenic-Sparing Block Combination (Experimental); Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Dexamethasone 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 H₂O) on the composite respiratory-compromise endpoint.
Unit of Measure: Interaction odds ratio (per 10 cm H₂O decrement in MIP).
Measured: Baseline (preoperative MIP test) and PACU assessment (30-60 minutes post-surgery).
Secondary outcomes (5)
Lowest Oxygen Saturation (SpO₂) in PACU
Minimum oxygen saturation recorded by pulse oximetry during the PACU stay Unit of Measure: Percent (%)
Measured: From PACU arrival to discharge (typically 60-120 minutes)
Total Duration of Supplemental Oxygen Use
Total number of hours on oxygen from PACU arrival until hospital discharge (maximum 24 hours).
Unit of Measure: Hours.
Measured: 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.
Measured: 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 (%).
Measured: 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.
Measured: Within 1 hour after PACU arrival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start21 Jan 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Regional Anesthesia
- Responsible party
- Sponsor
- Investigators
- Monika Nanda, Principal investigator, University of North Carollina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216820
- Sponsor's protocol ID
- 23-3332
- Status last verified
- Jan 2026
- First submitted
- 13 Oct 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene vs Phrenic-sparing Blocks in Obesity: Effect of Pre-operative Maximum Inspiratory Pressure in a Randomized Trial
- ClinicalTrials.gov ID
- NCT07216820
- Acronym / sponsor ID
- 23-3332
- Conditions
- Shoulder Surgery, Obesity
- Keywords
- interscalene block, phrenic-sparing block, brachial plexus block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Society of Regional Anesthesia
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Standard Interscalene Block | Active comparator | Procedure: Ultrasound-Guided Interscalene Brachial Plexus Block, Drug: Bupivacaine HCl 0.5% Injectable Solution, Drug: Dexamethasone 4mgStandard 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 | Procedure: Phrenic-Sparing Block Combination (Experimental), Drug: Bupivacaine HCl 0.5% Injectable Solution, Drug: Dexamethasone 4mgCombined 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years (self-report, confirmed on chart).
- Body-mass index ≥ 35 kg m^2 at the pre-operative clinic visit (chart).
- Scheduled for elective unilateral shoulder surgery (arthroscopy, arthroplasty, rotator cuff repair, reverse arthroplasty) under general anesthesia at UNC Hospitals
- Planned use of a single-injection regional brachial-plexus block for postoperative analgesia (anesthesia record).
- Able to perform a maximal-inspiratory-pressure (MIP) maneuver at screening, producing two reproducible efforts (bedside test)
Key exclusion criteria (11 listed)
- Emergent or trauma shoulder procedure or case converted to open surgery (schedule/chart).
- Pregnancy confirmed by point-of-care urine test on day of surgery (POC test). Prisoner status or legal incapacity to consent (chart/interview).
- Severe pulmonary disease: GOLD stage 3-4 COPD, restrictive lung disease unrelated to obesity with FVC < 50 % predicted, baseline dyspnea Borg ≥ 3, or home oxygen therapy (pulmonary clinic notes, patient interview).
- Severe heart disease- Severe valvular heart disease, Congestive Heart Failure NYHA Class III or IV, Obstructive Coronary Artery Disease with Angina
- Neuromuscular disorders affecting respiratory muscles (e.g., ALS, myasthenia gravis) or known diaphragmatic paralysis (chart).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Interscalene Brachial Plexus BlockSingle 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) | Procedure or surgery | Arm 1: Standard Interscalene Block |
| Phrenic-Sparing Block Combination (Experimental)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) | Procedure or surgery | Arm 2: Phrenic-Sparing Block Combination |
| Bupivacaine HCl 0.5% Injectable SolutionAlso: Bupivacaine Hydrochloride InjectionInfraclavicular: Adminstered as 15 mL (75 mg) injection (together with dexamethasone). Distal Suprascapular: Adminstered as 12 mL (60 mg) injection (together with dexamethasone). | Drug | Arm 1: Standard Interscalene Block, Arm 2: Phrenic-Sparing Block Combination |
| Dexamethasone 4mgAlso: Decadron, Dexamethasone Intensol, De-Sone LA, Dxevo, DexacortenAdminstered as applicable for infraclavicular and distal suprascapular: as 1 mL (4 mg) injection (together with bupicacaine 0.5%). | Drug | Arm 1: Standard Interscalene Block, Arm 2: Phrenic-Sparing Block Combination |
Primary outcome
Incidence of Early Postoperative Respiratory Compromise
Time frame: Within 60 minutes after arrival to PACU
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.
Effect Modification by Preoperative Maximum Inspiratory Pressure (MIP)
Time frame: Baseline (preoperative MIP test) and PACU assessment (30-60 minutes post-surgery).
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 H₂O) on the composite respiratory-compromise endpoint. Unit of Measure: Interaction odds ratio (per 10 cm H₂O decrement in MIP).
5 secondary outcomes
Lowest Oxygen Saturation (SpO₂) in PACU
Time frame: From PACU arrival to discharge (typically 60-120 minutes)
Total Duration of Supplemental Oxygen Use
Time frame: 0-24 hours post-surgery.
Post-Induction Opioid Consumption
Time frame: 0-6 hours post-surgery.
Diaphragmatic Excursion Change from Baseline
Time frame: Baseline (pre-block) and 30-60 minutes post-surgery in PACU.
PACU Pain Score
Time frame: Within 1 hour after PACU arrival.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monika Nanda principal investigator
University of North Carollina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Interscalene Brachial Plexus Block, Phrenic-Sparing Block Combination (Experimental) and Bupivacaine HCl 0.5% Injectable Solution in people with Shoulder Surgery and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Nanda (919-966-5136, mnanda@aims.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Early Postoperative Respiratory Compromise (time frame: Within 60 minutes after arrival to PACU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.