Nerve Block Techniques for Breathing After Shoulder Surgery in Obesity

MN
Overseen ByMonika Nanda
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to manage pain after shoulder surgery in people with obesity. It seeks to determine if a special nerve block technique, the Phrenic-Sparing Block Combination, can reduce breathing problems immediately after surgery compared to the usual method. Participants will be randomly assigned to receive either the new or standard pain relief method and will be monitored for breathing and pain levels. The trial seeks individuals with a body mass index (BMI) of 35 or higher who are scheduled for elective shoulder surgery and can perform a simple breathing test. As an unphased trial, it offers participants the chance to contribute to innovative pain management research that could improve surgical outcomes for others with obesity.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are using chronic opioids over 100 mg per day, you may not be eligible to participate.

What prior data suggests that these nerve block techniques are safe for breathing after shoulder surgery in adults with obesity?

Research has shown that the phrenic-sparing block, which includes specific nerve blocks near the shoulder, is generally well-tolerated. One study found that these nerve blocks help prevent breathing problems often associated with traditional methods, resulting in fewer breathing issues after surgery.

Specifically, the study found that these blocks can reduce breathing problems within 24 hours post-surgery, suggesting they are a safer choice for those concerned about breathing issues after shoulder surgery. Additionally, the amount of anesthetic used in these blocks remains within safe limits, further supporting their safety.

Overall, the phrenic-sparing block is considered a safe option for managing pain after shoulder surgery, particularly for those worried about breathing difficulties.12345

Why are researchers excited about this trial?

Researchers are excited about the nerve block techniques being explored because they offer a new approach to managing breathing difficulties after shoulder surgery, particularly in individuals with obesity. Unlike the standard interscalene block, which can sometimes affect the phrenic nerve and thus the diaphragm, the phrenic-sparing block combination specifically aims to minimize this risk. By using a combination of infraclavicular and distal suprascapular blocks, this technique reduces the likelihood of impacting the phrenic nerve, potentially improving breathing outcomes post-surgery. This innovative approach could provide a safer, more comfortable recovery for patients who are at a higher risk of respiratory complications.

What evidence suggests that these nerve block techniques are effective for reducing breathing problems after shoulder surgery in obesity?

Research shows that a new pain relief method, the phrenic-sparing nerve block, may help manage pain after shoulder surgery. In this trial, participants in one arm will receive this method, which combines infraclavicular and suprascapular nerve blocks. Studies have found that this combination reduces the need for extra pain medication after surgery. It targets specific nerves to control pain without affecting the phrenic nerve, crucial for breathing. This approach aims to manage pain effectively while reducing the risk of breathing problems common with standard methods. Overall, this method offers a good balance of pain control and safety.15678

Who Is on the Research Team?

MN

Monika Nanda

Principal Investigator

University of North Carollina at Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults with obesity undergoing shoulder surgery. Participants must be able to perform a simple breathing-strength test before surgery. Those who have conditions that might interfere with the nerve block techniques or assessments, or other factors that would exclude them from safely participating are not eligible.

Inclusion Criteria

Body-mass index ≥ 35 kg m² at the pre-operative clinic visit (chart)
Able to read or understand English and provide written informed consent (consent discussion)
I am scheduled for a one-time nerve block for pain relief after surgery.
See 3 more

Exclusion Criteria

Pregnancy confirmed by point-of-care urine test on day of surgery (POC test)
Prisoner status or legal incapacity to consent (chart/interview)
Allergy to bupivacaine, dexamethasone, or ultrasound gel (self-report)
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Assessment

Participants undergo a quick MIP breath test and, if age ≥65, a brief thigh muscle ultrasound

1 day
1 visit (in-person)

Treatment

Participants receive either the standard ISB or the phrenic-sparing block during surgery

1 day
1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for breathlessness, oxygen use, and pain control in the PACU

1-2 hours

Follow-up

Participants receive a follow-up call to assess any breathing-related complications or unplanned admissions

24-48 hours

What Are the Treatments Tested in This Trial?

Interventions

  • Phrenic-Sparing Block Combination
Trial Overview Researchers are testing if a phrenic-sparing nerve block reduces early postoperative breathing problems compared to the standard interscalene block in obese patients after shoulder surgery. They're also checking if a maximum inspiratory pressure test can predict respiratory risk.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Phrenic-Sparing Block CombinationExperimental Treatment3 Interventions
Group II: Arm 1: Standard Interscalene BlockActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

American Society of Regional Anesthesia

Collaborator

Trials
5
Recruited
310+

Citations

Efficacy of Phrenic Nerve Block and Suprascapular Nerve ...This study suggests that PNB ranks first for prevention and reduction of ISP severity during the first 24 h after thoracic surgery.
Efficacy of Infraclavicular Brachial Plexus Block Alone ...The combination of infraclavicular and suprascapular nerve blocks displays a positive postoperative analgesic profile with less use of rescue ...
Impact of Peripheral Nerve Block Technique on Incidence ...Peripheral nerve blocks are an increasingly common method of providing postoperative analgesia for shoulder surgeries.
Combined Infraclavicular-Suprascapular NerveThe gold standard analgesic for this type of surgery is the interscalene block (ISB), which minimizes pain for at least 8 hours and reduces opioid intake for ...
Impact of Peripheral Nerve Block Technique on Incidence of ...Peripheral nerve blocks are an increasingly common method of providing postoperative analgesia for shoulder surgeries.
OP62 Impact of peripheral nerve block technique on ...Background and Aims Peripheral nerve blocks are an increasingly common method of providing post-operative analgesia for shoulder surgery.
A Diaphragm-Sparing Nerve Block for Arthroscopic ...This study aims at assessing the effectiveness of combined supra scapular nerve block, infraclavicular block and supraclavicular nerve block as surgical ...
Adverse event reporting in ultrasound-guided brachial ...Superior trunk block is an effective phrenic-sparing alternative to Interscalene block for shoulder arthroscopy: a systematic review and Meta-analysis.
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