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Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

NCT06737237 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Clavicle Surgery
  • Clavicle Fracture
  • Acromioclavicular Joint
  • Coracoclavicular Ligament

Interventions

PROCEDURE

cervical plexus block

local anesthetic (10ml of bupivacaine 5mg/ml)

PROCEDURE

Local Infiltration Analgesia (LIA)

local anesthetic (20ml of bupivacaine 2.5mg/ml)

PROCEDURE

cervical plexus block

placebo (10ml of 0.9% sodium chloride)

PROCEDURE

Local Infiltration Analgesia (LIA)

placebo (20ml of 0.9% sodium chloride)

Sponsors & Collaborators

  • Naval Medical Center Camp Lejeune

    lead FED

Principal Investigators

  • CDR Lee, MD · DHA/MD365

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-08
Primary Completion
2028-02-08
Completion
2028-02-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06737237 on ClinicalTrials.gov