Clinical Trial

Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

Study acronym: CERPICO
Enrolling by Invitation
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-11.
Trial Details
NCT Number NCT06737237
Lead Sponsor Naval Medical Center Camp Lejeune
Conditions Clavicle Surgery, Clavicle Fracture, Acromioclavicular Joint, Coracoclavicular Ligament
Enrollment 40 participants
Start Date 2024-05-08
Primary Completion 2028-02-08 (estimated)
Study Completion 2028-02-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-16