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Enrolling by invitationNCT06737237CERPICOUpdated Apr 16, 2026

Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

An interventional study of cervical plexus block and Local Infiltration Analgesia (LIA) in Clavicle Surgery, Clavicle Fracture and Acromioclavicular Joint, sponsored by Naval Medical Center Camp Lejeune. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Naval Medical Center Camp Lejeune · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2024, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

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.

Read the detailed description

ALL PATIENTS (STANDARD CARE)

Patients will be administered a standardized anesthetic plan of preoperative anxiolysis (midazolam 2mg) and induction of anesthesia (lidocaine 1-1.5mg/kg, fentanyl 0.5-1.5mcg/kg, propofol 1-3mg/kg, and rocuronium 0.6-1.2mg/kg). Airway management will be at the discretion of the staff anesthesia provider.

Following endotracheal intubation, the anesthesia provider will perform an ultrasound-guided intermediate cervical plexus block. Ultrasound imaging will be used to identify the sternocleidomastoid muscle at its midpoint between origin and insertion. An echogenic needle will be advanced under live ultrasound guidance just deep to the posterior aspect of the sternocleidomastoid muscle.

UGICPB ARM (RESEARCH PROCEDURE)

LIA ARM (RESEARCH PROCEDURE)

10ml of bupivacaine 5mg/ml will be injected in 2ml aliquots with intermittent aspiration under direct visualization to confirm appropriate solution propagation and to avoid intravascular injection.

10ml normal saline will be injected in 2ml aliquots with intermittent aspiration under direct visualization to confirm appropriate solution propagation and to avoid intravascular injection.

ALL PATIENTS (STANDARD CARE)

Patients will then be administered a standardized anesthetic maintenance plan consisting of sevoflurane to age-adjusted MAC of >0.5, acetaminophen 1000mg IV, dexamethasone 10mg IV, ketorolac 30mg IV, tranexamic acid 1000mg IV, and rocuronium for neuromuscular blockade as indicated. The antibiotic regimen will be at the discretion of the orthopedic surgeon. For intraoperative pain control, the anesthesia provider will administer fentanyl 25-100mcg q5 min for HR and/or BP >20% baseline attributable to pain in the judgment of the anesthesia provider. No alternative opioids or adjuncts, such as nitrous oxide, ketamine, or dexmedetomidine, will be administered.

UGICPB ARM (RESEARCH PROCEDURE)

LIA ARM (RESEARCH PROCEDURE)

Prior to wound closure, the orthopedic surgeon will infiltrate the anticipated surgical site with 20ml of normal saline using a landmark-based technique.

Prior to wound closure, the orthopedic surgeon will infiltrate the anticipated surgical site with 20ml of bupivacaine 2.5mg/ml using a landmark-based technique.

ALL PATIENTS (STANDARD CARE)

Intermittent aspiration will be performed to avoid intravascular injection. The injectate will be evenly distributed along the skin, subcutaneous plane, musculature, and periosteum.

All patients will receive sugammadex 2-4mg/kg for reversal of neuromuscular blockade prior to emergence. Ondansetron 4mg may be given at the discretion of the staff anesthesia provider. Airway management for extubation will be at the discretion of the staff anesthesia provider; however, patients will not be transported to the PACU until emerged from general anesthesia.

On arrival to the PACU, the PACU nurse will perform their normal duties, including recording the times of PACU admission and discharge, initial and maximum pain score during phase 1 recovery, pain score at time of discharge, presence of nausea, administration of anti-emetic medication, emetic events, and incidence of Horner's syndrome in the patient's chart.

The PACU nurse will also, as a part of their normal duties, administer fentanyl per the standard institutional order set (25mcg fentanyl every 5 minutes as needed for pain score 1-4, 50mcg fentanyl every 10 minutes as needed for pain score 5-6, and 50mcg fentanyl every 5 minutes as needed for pain score 7-10) in the event rescue analgesia is indicated, up to a maximum of 250 mcg while in recovery phase 1. If the subject's pain continues to be uncontrolled after the administration of 250 mcg of fentanyl, or if the risk of continued opioid administration outweighs the benefit (in the opinion of the PACU anesthesia provider), alternative analgesics may then be utilized at the discretion of said PACU anesthesia provider. Additionally, the PACU nurse will record

Patients will be discharged with 800mg ibuprofen every 8 hours as needed, 1000mg acetaminophen every 8 hours as needed, and 5mg oxycodone every 6 hours as needed (15 tablets) for post-discharge analgesia, as is standard.

ALL PATIENTS (RESEARCH PROCEDURE)

After the patient has been discharged from the PACU, the Primary Investigators will retroactively collect the data from the OR and PACU that has been recorded in the patient's chart by their treatment providers. Note that the Primary Investigators will not make any treatment decisions or patient assessments, only record the existing information that other healthcare providers have collected.

Before discharge, the patient will receive a one-page pain diary on which to record answers regarding their pain level for the first 24-36 hours, to aid them in recalling their pain details for the post-op phone call.

02

Conditions studied

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

Keywords

  • clavicle surgery
  • cervical plexus block
  • local infiltration analgesia
03

In context

Lead sponsor

Naval Medical Center Camp Lejeune is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
40 participants (estimated)

Study 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)

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

  • 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)

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

Interventions

  • Procedurecervical plexus block

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

  • ProcedureLocal Infiltration Analgesia (LIA)

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

  • Procedurecervical plexus block

    placebo (10ml of 0.9% sodium chloride)

  • ProcedureLocal Infiltration Analgesia (LIA)

    placebo (20ml of 0.9% sodium chloride)

06

What researchers measure

Primary outcomes

  1. Total Perioperative Intravenous Fentanyl Administration

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

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

Secondary outcomes

  1. PACU Pain Scores

    PACU pain score on time of PACU admission (0-10 on Numeric Pain Rating Scale), maximum pain score during PACU (0-10 on Numeric Pain Rating Scale), and pain score on discharge from PACU (0-10 on Numeric Pain Rating Scale)

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

  2. PACU Rescue Analgesia

    The need for non-fentanyl analgesic medications during PACU recovery (yes/no)

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

  3. Post-discharge Pain Scores

    Lowest pain score (0-10 on Numeric Pain Rating Scale), highest pain score (0-10 on Numeric Pain Rating Scale), average pain score (0-10 on Numeric Pain Rating Scale)

    Time frame: Night-of-surgery to postoperative day one

  4. Postdischarge Oral Narcotic Use

    Quantity of oxycodone 5mg oral tablets required from night-of-surgery to postoperative day one

    Time frame: Night-of-surgery to postoperative day one

  5. Postdischarge rebound pain

    The difference between pain scores (0-10 on Numeric Pain Rating Scale) when local anesthetic effect began to wear off and when local anesthetic effect wore off completely

    Time frame: Night-of-surgery to postoperative day one

  6. Return to Emergency Room Rate

    The need to return to the emergency room for pain control from night-of-surgery to postoperative day one (yes/no)

    Time frame: Night-of-surgery to postoperative day one

  7. Patient Satisfaction with Analgesia

    The patient's overall satisfaction with postoperative pain management (Likert five-point scale, 1 being very dissatisfied to 5 being very satisfied)

    Time frame: End-of-surgery to postoperative day one

  8. PACU Adverse Event Rate

    The rate of PACU nausea/vomiting (yes/no), respiratory depression (yes/no), motor block (yes/no), and horner's syndrome (yes/no)

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

07

Study locations

1 site
  • Naval Medical Center Camp Lejeune
    Marine Corps Base Camp Lejeune, North Carolina 28443, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 8, 2024
  • Informed consent form · Feb 8, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06737237
Lead sponsor
Naval Medical Center Camp Lejeune
Responsible party
Michael Lee (Principal Investigator, Naval Medical Center Camp Lejeune) — Principal investigator
First posted
Dec 17, 2024
Start date
May 8, 2024
Primary completion
Feb 8, 2028 (estimated)
Completion
Feb 8, 2028 (estimated)
Last update
Apr 16, 2026

Study contacts

CDR Lee, MD
principal investigator · DHA/MD365

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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