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Clavicle SurgeryCERPICONCT06737237

Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

A study testing cervical plexus block and Local Infiltration Analgesia (LIA) in people with Clavicle Surgery and Clavicle Fracture, run by Naval Medical Center Camp Lejeune at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
cervical plexus block and Local Infiltration Analgesia (LIA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
8 May 2024to 8 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Naval Medical Center Camp Lejeune

    Marine Corps Base Camp Lejeune, North Carolina, 28443

Other trials in United States

About this study

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.

Being tested
cervical plexus block, Local Infiltration Analgesia (LIA)
Keywords
clavicle surgery, cervical plexus block, local infiltration analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cervical plexus blockProcedure or surgery

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

  • Local Infiltration Analgesia (LIA)Procedure or surgery

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

  • cervical plexus blockProcedure or surgery

    placebo (10ml of 0.9% sodium chloride)

  • Local Infiltration Analgesia (LIA)Procedure or surgery

    placebo (20ml of 0.9% sodium chloride)

Study groups in NCT06737237
Study groupRoleWhat they receive
ultrasound guided cervical plexus blockActive comparatoru/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)
Receives: Procedure: cervical plexus block; Procedure: Local Infiltration Analgesia (LIA)
local infiltration analgesiaActive comparatorsurgeon-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)
Receives: Procedure: Local Infiltration Analgesia (LIA); Procedure: cervical plexus block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Perioperative Intravenous Fentanyl Administration

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

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

Secondary outcomes (8)
  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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2024
  2. Study start8 May 2024
  3. Primary completion8 Feb 2028 (estimated)
  4. Study completion8 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06737237
Sponsor's protocol ID
NMCCL.2024.0027
Other IDs
NMCCL.2024.0027
Acronym
CERPICO
Status last verified
Apr 2026
First submitted
6 Dec 2024
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing cervical plexus block and Local Infiltration Analgesia (LIA) in people with Clavicle Surgery and Clavicle Fracture, run by Naval Medical Center Camp Lejeune at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Perioperative Intravenous Fentanyl Administration (time frame: from anesthesia start time to discharge from PACU, estimated 3-4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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