Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

NCT06737237 | Enrolling By Invitation DMC

• 1 other identifier: NMCCL.2024.0027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

clavicle surgery; cervical plexus block; local infiltration analgesia

Outcome Measures

Primary Outcomes (1)

• Total Perioperative Intravenous Fentanyl Administration

  total fentanyl dosage (mcg) encompassing the intraoperative and PACU recovery periods

  from anesthesia start time to discharge from PACU, estimated 3-4 hours

Secondary Outcomes (8)

• PACU Pain Scores

  from time of PACU admission to time of PACU discharge, estimated 30-60 minutes

• PACU Rescue Analgesia

  from time of PACU admission to time of PACU discharge, estimated 30-60 minutes

• Post-discharge Pain Scores

  Night-of-surgery to postoperative day one

• Postdischarge Oral Narcotic Use

  Night-of-surgery to postoperative day one

• Postdischarge rebound pain

  Night-of-surgery to postoperative day one

Study Arms (2)

ultrasound guided cervical plexus block

ACTIVE COMPARATOR

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)

Procedure: cervical plexus block; Procedure: Local Infiltration Analgesia (LIA)

local infiltration analgesia

ACTIVE COMPARATOR

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)

Procedure: Local Infiltration Analgesia (LIA); Procedure: cervical plexus block

Interventions

cervical plexus block PROCEDURE

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

ultrasound guided cervical plexus block

Local Infiltration Analgesia (LIA) PROCEDURE

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

local infiltration analgesia

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-64 years
• Scheduled surgery of the clavicle, acromioclavicular joint, or coracoclavicular ligament at NMCL
• ASA Physical Status Classification 1-3

You may not qualify if:

• Emergent surgery
• Concurrent surgery involving the glenobumeral joint or proximal humerus
• Prior anaphylactic reaction or known intolerance to study medications
• Patient reported or documented opioid use within the last 30 days unrelated to clavicular, AC joint, or CC ligament pathology

Sponsors & Collaborators

• Naval Medical Center Camp Lejeune: lead

Study Sites (1)

Naval Medical Center Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, 28443, United States

Location

MeSH Terms

Interventions

Cervical Plexus Block

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• CDR Lee, MD

  DHA/MD365

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Clinical Research Coordinator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 17, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): February 8, 2028
• Study Completion (Estimated): February 8, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)