Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

NCT ID: NCT06737237

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2026-02-08

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.

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.

Conditions

Clavicle Surgery; Clavicle Fracture; Acromioclavicular Joint; Coracoclavicular Ligament

Keywords

clavicle surgery; cervical plexus block; local infiltration analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

cervical plexus block

Intervention Type: PROCEDURE

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

Local Infiltration Analgesia (LIA)

Intervention Type: PROCEDURE

placebo (20ml of 0.9% sodium chloride)

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)

Group Type: ACTIVE_COMPARATOR

Local Infiltration Analgesia (LIA)

Intervention Type: PROCEDURE

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

cervical plexus block

Intervention Type: PROCEDURE

placebo (10ml of 0.9% sodium chloride)

Interventions

cervical plexus block

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

Intervention Type: PROCEDURE

Local Infiltration Analgesia (LIA)

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

Intervention Type: PROCEDURE

cervical plexus block

placebo (10ml of 0.9% sodium chloride)

Intervention Type: PROCEDURE

Local Infiltration Analgesia (LIA)

placebo (20ml of 0.9% sodium chloride)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Naval Medical Center Camp Lejeune

FED

Sponsor Role: lead

Responsible Party

Michael Lee

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CDR Lee, MD

Role: PRINCIPAL_INVESTIGATOR

DHA/MD365

Locations

Naval Medical Center Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NMCCL.2024.0027

Identifier Type: OTHER

Identifier Source: secondary_id

NMCCL.2024.0027

Identifier Type: -

Identifier Source: org_study_id