Nerve Block Timing for Shoulder Pain

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Concurrent surgery, ASA > II, Allergies, Sedation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

79 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a procedure where pain medication is injected near neck nerves to manage pain after shoulder surgery. It targets healthy adolescents having shoulder reconstruction. The treatment works by numbing the nerves to block pain signals, helping reduce the need for other painkillers and speeding up recovery. This method has been found to be the most effective way to control pain after shoulder surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of this treatment for shoulder pain?

Research shows that interscalene block, whether continuous or single shot, is effective for controlling severe pain after shoulder surgery, helping with early rehabilitation. Continuous interscalene block, especially with a catheter, is considered the best technique for pain relief after major shoulder surgery. ^{1 2 3 4 5}

Is the interscalene block generally safe for shoulder surgery?

Interscalene block is generally considered safe for shoulder surgery, but it can cause hemidiaphragmatic paresis (temporary partial paralysis of the diaphragm), which is a risk for people with serious lung problems. ^{1 4 5 6 7}

How does the timing of interscalene block treatment for shoulder pain differ from other treatments?

The timing of interscalene block treatment for shoulder pain is unique because it can be administered either before (preemptive) or after (postoperative) surgery, and can be delivered as a single shot or continuously through a catheter. This flexibility allows for tailored pain management, potentially reducing the need for opioids and minimizing their side effects. ^{4 5 8 9 10}

Research Team

Marc Mecoli, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for individuals aged 10-21 years with shoulder injuries requiring surgery, who are in good health (ASA I-II). They must consent to a nerve block and not have other surgeries at the same time. Excluded are those with severe health issues, pre-op sedation, allergies to local anesthetics, or conditions making them unsuitable for the study.

Inclusion Criteria

I am between 10 and 21 years old.

I have agreed to a specific type of anesthesia for my procedure, and a qualified clinician not involved in the study has obtained my consent.

I am in good or mild systemic disease condition according to ASA.

Exclusion Criteria

The subject has an imminent life-threatening condition that impacts the ability to obtain informed consent

I will be given sedation before surgery.

You have allergies to local numbing medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive interscalene brachial plexus blockade either prior to or following shoulder surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain efficacy and safety after the nerve block procedure

1 week

1 visit (in-person)

Treatment Details

Interventions

• Postoperative Interscalene Block - Catheter
• Postoperative Interscalene Block- Single Shot
• Preemptive Interscalene Block - Catheter
• Preemptive Interscalene Block - Single Shot

Trial Overview The study compares different timings of administering a nerve block—either before or after shoulder surgery—to see which method better reduces post-operative pain. Participants will receive either a single shot or continuous catheter-delivered nerve blockade.

Participant Groups

Group I: Preemptive Interscalene Block - Single Shot Active Control 1 Intervention

Group II: Postoperative Interscalene Block - Single Shot Active Control 1 Intervention

Group III: Preemptive Interscalene Block - Catheter Active Control 1 Intervention

Group IV: Postoperative Interscalene Block - Catheter Active Control 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Findings from Research

The modified lateral technique for interscalene block is highlighted as the safest and most effective method for pain control after major shoulder surgery, facilitating early rehabilitation.

Continuous infusion of local anesthetics through an interscalene catheter provides superior pain relief both at rest and during movement, making it the best technique for managing postoperative pain in shoulder surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaesthesia for shoulder surgery. Borgeat, A., Ekatodramis, G.[2022]

Both arthroscopic and open shoulder surgeries lead to significant postoperative pain, and a multi-modal approach to pain management is recommended to reduce opioid use and its side effects.

Interscalene block provides effective pain relief for shoulder surgery but carries a risk of hemidiaphragmatic paresis, especially in patients with serious lung issues; continuous interscalene block may be beneficial for more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative analgesia for shoulder surgery. Desai, N.[2019]

The modified lateral approach for interscalene catheter placement in 700 patients resulted in a high success rate for anesthesia (97%) and effective postoperative pain relief (99%), indicating its efficacy for shoulder surgery.

The study reported low rates of complications, with only 0.7% experiencing local infections and minor neurologic issues observed in 2.4% of patients, while patient satisfaction averaged 9.6 out of 10, highlighting the safety and acceptability of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the lateral modified approach for continuous interscalene block after shoulder surgery. Borgeat, A., Dullenkopf, A., Ekatodramis, G., et al.[2019]

In a meta-analysis of 16 studies involving 1,152 patients, both interscalene and suprascapular blocks showed similar effectiveness in reducing postoperative pain and opioid consumption after shoulder surgery, with no clinically meaningful differences in analgesic outcomes.

While interscalene block provided slightly better pain control during recovery, suprascapular block was associated with fewer block-related and respiratory complications, suggesting it may be a safer alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Hussain, N., Goldar, G., Ragina, N., et al.[2018]

A continuous interscalene block is an effective method for managing postoperative pain after major shoulder surgery, providing significant pain relief.

The article reviews the stimulating catheter technique for this block, detailing the authors' experience with the first 200 catheters placed, indicating a practical application of the technique in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous interscalene block using a stimulating catheter: a review of the technique. van de Putte, P., van der Vorst, M.[2005]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Anaesthesia for shoulder surgery. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Perioperative interscalene block versus intra-articular injection of local anesthetics for postoperative analgesia in shoulder surgery. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Continuous interscalene brachial plexus block for postoperative analgesia following shoulder surgery. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Postoperative analgesia for shoulder surgery. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the lateral modified approach for continuous interscalene block after shoulder surgery. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of Dexmedetomidine and Dexamethasone as Adjuvants to Ultra-Sound Guided Interscalene Block in Arthroscopic Shoulder Surgery: A Double-Blinded Randomized Placebo-Controlled Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

[Pain management in shoulder surgery]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Arthroscopic Shoulder Surgery With Interscalene Brachial Plexus Nerve Block Using Liposomal Bupivacaine: A Prospective Observational Study. [2020]

10. Belgium pubmed.ncbi.nlm.nih.gov

Continuous interscalene block using a stimulating catheter: a review of the technique. [2005]