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临床试验/NCT06737237
NCT06737237Enrolling By Invitation不适用

Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)

Naval Medical Center Camp Lejeune1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
Total Perioperative Intravenous Fentanyl Administration

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Clinical Research Coordinator

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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)

干预措施: Local Infiltration Analgesia (LIA) (Procedure)

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)

干预措施: Local Infiltration Analgesia (LIA) (Procedure)

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)

干预措施: cervical plexus block (Procedure)

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)

干预措施: cervical plexus block (Procedure)

结局指标

主要结局

Total Perioperative Intravenous Fentanyl Administration

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

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

次要结局

  • Postdischarge Oral Narcotic Use(Night-of-surgery to postoperative day one)
  • 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 rebound pain(Night-of-surgery to postoperative day one)
  • Return to Emergency Room Rate(Night-of-surgery to postoperative day one)
  • Patient Satisfaction with Analgesia(End-of-surgery to postoperative day one)
  • PACU Adverse Event Rate(from time of PACU admission to time of PACU discharge, estimated 30-60 minutes)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Michael Lee

Principal Investigator

Naval Medical Center Camp Lejeune

研究点 (1)

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