Continuous Cervical Erector Spinae Plane Block Versus Interscalene Nerve Block in Shoulder Arthroscopic Surgery- A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity within postoperative 24 hours
概览
简要总结
Shoulder arthroscopic surgery is associated with moderate to severe postoperative pain, which may hinder early mobilization and functional recovery. Interscalene block (ISB) is commonly used to provide effective analgesia but is frequently associated with hemidiaphragmatic paralysis due to phrenic nerve involvement. Cervical erector spinae plane block (ESPB) has been proposed as an alternative regional technique that may provide analgesia while reducing respiratory-related adverse effects. This randomized controlled trial aims to compare the analgesic efficacy and safety of cervical ESPB versus continuous ISB in patients undergoing shoulder arthroscopic surgery.
详细描述
This study is a prospective randomized controlled trial designed to evaluate whether continuous cervical erector spinae plane block (ESPB) is non-inferior to continuous interscalene block (ISB) for postoperative pain control in adult patients undergoing elective shoulder arthroscopic surgery. Eligible participants will be allocated to one of three groups: continuous cervical ESPB, continuous ISB, or a prospective observational control group receiving standard institutional analgesia with single-shot ISB.
Randomization with allocation concealment will be applied to the two interventional groups. Patients and outcome assessors will be blinded to group allocation. All regional anesthesia techniques will be performed as part of a standardized multimodal analgesic protocol.
The primary outcome is postoperative pain intensity measured using the visual analogue scale (VAS) at 24 hours after surgery. Secondary outcomes include pain scores at additional postoperative time points, cumulative opioid consumption expressed as oral morphine equivalents, measures of functional recovery, and the incidence of block-related adverse events. Respiratory-related outcomes, including hemidiaphragmatic paralysis assessed by ultrasound, as well as motor and sensory deficits and postoperative nausea and vomiting, will also be evaluated.
Analyses of the randomized intervention groups will be conducted on an intention-to-treat basis. Data from the observational control group will be analyzed descriptively to provide reference information on usual-care outcomes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective shoulder arthroscopic surgery
排除标准
- •Contraindications to regional analgesia
- •ASA physical status IV
- •history of drug or opioid abuse
- •preoperative upper limb motor impairment
- •postoperative ventilator support or ICU admission
- •Inability to provide self-reported pain assessments
研究组 & 干预措施
Continuous Cervical Erector Spinae Plane Block
Participants will receive an ultrasound-guided continuous cervical erector spinae plane block with perineural catheter placement as part of a standardized multimodal analgesia regimen for shoulder arthroscopic surgery. Postoperative analgesia will be provided via continuous local anesthetic infusion through the catheter per institutional protocol.
干预措施: Continuous Cervical Erector Spinae Plane Block (Procedure)
Continuous Interscalene Block
Participants will receive an ultrasound-guided continuous interscalene block with perineural catheter placement as part of a standardized multimodal analgesia regimen for shoulder arthroscopic surgery. Postoperative analgesia will be provided via continuous local anesthetic infusion through the catheter per institutional protocol.
干预措施: Continuous Interscalene Block (Procedure)
Single-Shot Interscalene Block
Observational
干预措施: No intervention (Procedure)
结局指标
主要结局
Postoperative pain intensity within postoperative 24 hours
时间窗: 2 hour, 6 hours, 12 hours, and 24 hours postoperatively
Postoperative pain intensity will be assessed using a 0-10 visual analogue scale (VAS) at 2, 6, 12, and 24 hours after surgery.
次要结局
- Motor blockade severity(Up to 48 hours postoperatively)
- analgesic consumption(48 hours)
- Adverse events(7 days)
- Duration of motor blockade(Up to 48 hours postoperatively)
- Sensory blockade distribution(Up to 48 hours postoperatively)
- Duration of sensory blockade(Up to 48 hours postoperatively)