Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• cervical plexus block — PROCEDURE
  local anesthetic (10ml of bupivacaine 5mg/ml)
• Local Infiltration Analgesia (LIA) — PROCEDURE
  local anesthetic (20ml of bupivacaine 2.5mg/ml)
• cervical plexus block — PROCEDURE
  placebo (10ml of 0.9% sodium chloride)
• Local Infiltration Analgesia (LIA) — PROCEDURE
  placebo (20ml of 0.9% sodium chloride)

Study Details

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.

Key Dates

Start date

May 8, 2024

Status verified

Apr 2026

Primary completion

Feb 8, 2028

Completion

Feb 8, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ultrasound guided cervical plexus block
  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)
• Active Comparator: local infiltration analgesia
  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)

Primary Outcome Measure

Total Perioperative Intravenous Fentanyl Administration [ Time Frame: from anesthesia start time to discharge from PACU, estimated 3-4 hours ]

Locations (1)

Find similar trials in Marine Corps Base Camp Lejeune, NC

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