Pain Management Techniques for Collarbone Fracture

(CERPICO Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Naval Medical Center Camp Lejeune

Must not be taking: Opioids

Disqualifiers: Emergent surgery, others

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

Compensation: Varies

Number of Visits: 3

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have used opioids in the last 30 days for reasons unrelated to your clavicle, AC joint, or CC ligament, you may not be eligible to participate.

What data supports the effectiveness of the treatment Cervical Plexus Block, Local Infiltration Analgesia for collarbone fracture pain management?

Research shows that using a combination of nerve blocks, like the cervical plexus block, can effectively manage pain during and after clavicle (collarbone) surgery. Studies have found that these blocks can provide adequate anesthesia and pain relief without needing additional pain medications. ^{1 2 3 4 5}

Is the cervical plexus block safe for pain management in collarbone fractures?

The cervical plexus block, often combined with an interscalene brachial plexus block, has been used safely for clavicle surgeries, with studies reporting no adverse events and reduced pain scores compared to general anesthesia. ^{1 2 4 6 7}

How does the cervical plexus block treatment differ from other treatments for collarbone fracture pain management?

The cervical plexus block is unique because it targets specific nerves in the neck to provide pain relief for collarbone fractures, potentially reducing the need for opioids and avoiding the muscle weakness associated with other regional anesthesia techniques like the interscalene block. ^{2 3 4 5 7}

What is the purpose of this trial?

Clavicle fractures are the most common fracture of the shoulder girdle, with young men being the most affected demographic. The incidence of clavicle fracture among military service members is 1.5-3x higher than the general adult population. While many clavicle fractures may be managed non-operatively, surgical intervention for clavicular fractures has shown improved functional outcomes in the active-duty Marine Corps population and an overall satisfactory return-to-duty rate. However, surgical fixation of the clavicle is associated with significant postoperative pain when no local anesthetic techniques are employed. Several regional anesthetic and local infiltrative analgesic regimens have been studied to improve postoperative pain control for clavicle ORIF with the authors concluding that intermediate cervical plexus block is the regional anesthesia therapy of choice for post-operative analgesia. A retrospective study by the same group determined that an intermediate cervical plexus block resulted in lower postoperative pain scores and opioid requirements than surgeon-administered local infiltration analgesia. This retrospective study unfortunately lacked participant blinding, randomization, a standardized anesthetic, consistent block technique, and protocolized postoperative analgesia. To date, no prospective trial has been performed directly comparing these two techniques. We propose, given the significance of clavicle fractures and corrective surgery in the military population, to study the efficacy of ultrasound-guided intermediate cervical plexus blocks as compared to local infiltration analgesia.

Research Team

CDR Lee, MD

Principal Investigator

DHA/MD365

Eligibility Criteria

This trial is for individuals with shoulder injuries like separated shoulders or collarbone fractures. It's particularly focused on military service members who have a higher incidence of these injuries and may require surgery. Participants must be eligible for surgical intervention and interested in postoperative pain management options.

Inclusion Criteria

My health is good to moderately impaired.

I am scheduled for surgery on my shoulder area at NMCL.

Exclusion Criteria

I need surgery urgently.

Prior anaphylactic reaction or known intolerance to study medications

I have used opioids in the last month not for shoulder-related pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Standardized anesthetic plan including preoperative anxiolysis and induction of anesthesia

1 day

1 visit (in-person)

Surgical Procedure

Ultrasound-guided intermediate cervical plexus block or local infiltration analgesia performed during clavicle surgery

1 day

1 visit (in-person)

Postoperative Recovery

Monitoring in PACU with pain management and data collection

3-4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-discharge pain management

1-2 days

Treatment Details

Interventions

• Cervical Plexus Block
• Local Infiltration Analgesia

Trial Overview The CERPICO study is testing two types of local anesthesia to manage pain after clavicle surgery: cervical plexus block versus local infiltration analgesia (LIA). The goal is to see which method provides better pain relief and reduces the need for opioids after surgery.

Participant Groups

Group I: ultrasound guided cervical plexus block Active Control 2 Interventions

u/s guided cervical plexus block will be performed with active local anesthetic, while the surgeon-administered local infiltration analgesia will be performed with placebo (0.9% sodium chloride)

Group II: local infiltration analgesia Active Control 2 Interventions

surgeon-administered local infiltration analgesia will be performed with active local anesthetic, while the u/s guided cervical plexus block will be performed with placebo (0.9% sodium chloride)

Who Is Running the Clinical Trial?

Naval Medical Center Camp Lejeune

Lead Sponsor

Trials

3

Recruited

170+

References

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

Combined Interscalene Brachial Plexus and Superficial Cervical Plexus Nerve Block for Midshaft Clavicle Surgery: A Case Series. [2020]

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

Regional anesthesia for clavicle fracture surgery is safe and effective. [2021]

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

Could C3, 4, and 5 Nerve Root Block be a Better Alternative to Interscalene Block Plus Intermediate Cervical Plexus Block for Patients Undergoing Surgery for Midshaft and Medial Clavicle Fractures? A Randomized Controlled Trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Regional Anesthetic and Analgesic Techniques for Clavicle Fractures and Clavicle Surgeries: Part 1-A Scoping Review. [2022]

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

Ultrasound-Guided Combined Interscalene-Cervical Plexus Block for Surgical Anesthesia in Clavicular Fractures: A Retrospective Observational Study. [2022]

6. Nepal pubmed.ncbi.nlm.nih.gov

Regional Anaesthesia in Clavicle Surgery. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Regional Anesthetic and Analgesic Techniques for Clavicle Fractures and Clavicle Surgeries: Part 2-A Retrospective Study. [2023]