Nerve Block Timing for Shoulder Pain

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Medical Center, Cincinnati
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 explores different methods of administering nerve blocks, which reduce pain during shoulder surgery. The goal is to determine if one method manages post-surgery pain more effectively than others. The trial compares four types of nerve blocks, administered either before or after surgery, using catheters (small tubes) or single injections. Suitable candidates for this trial are those scheduled for a single shoulder surgery and who have agreed to receive a nerve block as part of their procedure. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance pain management techniques for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that nerve blocks are generally safe and effective for managing pain after shoulder surgery. Studies have found that single-shot interscalene blocks usually lead to fewer complications than continuous catheter blocks. Single-shot blocks provide significant short-term pain relief and are easier to administer. They also result in fewer emergency visits and require less time to administer.

In contrast, continuous catheter blocks extend pain relief and reduce the need for strong painkillers, but they carry a slightly higher risk of minor issues, such as pain near the catheter site.

Overall, both types of nerve blocks are well-tolerated by patients. The choice may depend on the desired duration of pain relief versus the likelihood of minor side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the different timing methods of administering interscalene blocks for shoulder pain because they could offer significant advantages over current standard treatments, such as oral pain medications and traditional nerve blocks applied post-surgery. The trial is exploring both preemptive and postoperative approaches, using either a single shot or a catheter method. The preemptive approach aims to manage pain before it begins, potentially reducing the need for opioids and enhancing recovery. Meanwhile, the catheter method provides continuous pain relief, which might result in better pain control and improved patient comfort. By comparing these different timings and methods, the trial seeks to optimize pain management and improve patient outcomes after shoulder surgery.

What evidence suggests that this trial's nerve block methods could be effective for shoulder pain?

Research shows that both preemptive and postoperative interscalene blocks effectively manage shoulder pain after surgery. In this trial, participants will receive one of the following treatments: a preemptive or postoperative interscalene block, administered either as a continuous catheter block or a single-shot block. Studies indicate that a continuous catheter block can relieve pain for up to 48 hours, reducing the need for additional painkillers. Single-shot blocks, however, provide quick pain relief and take less time to administer. Both methods help reduce opioid use and their side effects. Current research focuses on determining which method—preemptive or postoperative, catheter or single-shot—best manages pain. Overall, these treatments significantly relieve pain after shoulder surgery.56789

Who Is on the Research Team?

MM

Marc Mecoli, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.
See 5 more

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.
See 3 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Active Control
Group I: Preemptive Interscalene Block - Single ShotActive Control1 Intervention
Group II: Postoperative Interscalene Block - Single ShotActive Control1 Intervention
Group III: Preemptive Interscalene Block - CatheterActive Control1 Intervention
Group IV: Postoperative Interscalene Block - CatheterActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Published Research Related to This Trial

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.
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.
Evaluation of the lateral modified approach for continuous interscalene block after shoulder surgery.Borgeat, A., Dullenkopf, A., Ekatodramis, G., et al.[2019]
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.
Continuous interscalene block using a stimulating catheter: a review of the technique.van de Putte, P., van der Vorst, M.[2005]

Citations

Interscalene Block for Analgesia in Orthopedic Treatment ...ISB-LB is a promising technique for providing extended shoulder analgesia, despite limited published data comparing its analgesic effectiveness ...
The effect of continuous interscalene brachial plexus block ...Continuous interscalene brachial plexus block showed significant analgesic effect up to 2 days postoperatively. Stevens et al. reported that using the ...
Continuous Catheter Versus Single-Shot Interscalene ...Single-shot ISBs provide significant immediate postoperative pain relief, whereas CISBs offer prolonged analgesia beyond 48 hours, reduced opioid consumption, ...
NCT01696188 | A Study Comparing Two Methods of ...Perineural interscalene catheters offer the advantage of extended pain relief up to 48 hours after shoulder surgery. This is a prospective, randomized trial ...
Reducing rebound pain severity after arthroscopic ...Hydromorphone 2 mg given six hours after interscalene block did not reduce the severity of rebound pain postoperatively compared with placebo.
Recent updates on interscalene brachial plexus block for ...Patients who receive ISBPB experience excellent pain control while the block is active, but they may experience significantly more pain than those who do not ...
Adverse events associated with continuous interscalene block ...However, continuous interscalene block performed using the catheter-through-needle method is reportedly associated with adverse events such as pericatheter ...
Shoulder Rotator Cuff Complication rates and efficacy of ...CIC interscalene nerve blocks had an increased risk for injection site complications and minor complications in the immediate postoperative period.
An update on regional anesthesia in shoulder surgeryLiposomal bupivacaine (LB), a newer advancement, increases nerve block duration but has shown mixed evidence in improving patient outcomes.
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