Pain Management Protocol Optimization for Rebound Pain Prevention and Enhanced Recovery After Shoulder Surgery: A Randomized Noninferiority Trial of Intravenous Dexamethasone Combined With Single-Shot Versus Continuous Brachial Plexus Block
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Rebound Pain Score (RPS)
研究概览
简要总结
Shoulder surgery often causes severe pain after the operation. To control this pain, doctors commonly perform a nerve block (interscalene brachial plexus block), which numbs the shoulder area. However, when the effect of a single-injection nerve block wears off, many patients experience sudden, intense pain known as "rebound pain".
One way to prevent rebound pain is to place a thin catheter near the nerves so that local anesthetic can be given continuously for a longer period (continuous nerve block). However, this method is technically demanding and can cause problems such as catheter dislodgement, infection, and inconvenience for patients. Another simpler option is to give a single-injection nerve block together with an intravenous (IV) injection of dexamethasone, a steroid medication known to prolong the effect of nerve blocks and reduce rebound pain.
The purpose of this study is to determine whether a single-injection nerve block combined with IV dexamethasone (5 mg) is not inferior to a continuous nerve block in preventing rebound pain after shoulder surgery. A total of 92 adult patients scheduled for elective shoulder surgery will be randomly assigned to one of the two groups. The main outcome is the rebound pain score, defined as the difference between the last pain score recorded in the recovery room (while the nerve block is still working) and the highest pain score reported within the first 24 hours after the nerve block. The investigators expect that the simpler single-injection method with IV dexamethasone will provide comparable pain control while avoiding the complications and inconvenience of catheter-based continuous nerve blocks.
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
- None
盲法说明
Due to the nature of the intervention (presence or absence of a perineural catheter), participants, care providers, and outcomes assessors are not masked. The statistician performing the analysis will remain blinded to group allocation until the analysis is completed.
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 19 to 79 years scheduled for elective shoulder surgery under brachial plexus block and monitored anesthesia care (MAC)
排除标准
- •Pre-existing neurological deficit of the brachial plexus
- •Emergency surgery
- •American Society of Anesthesiologists (ASA) physical status classification IV or higher
- •Contraindication or history of hypersensitivity to local anesthetics or dexamethasone
- •Severe pulmonary disease (e.g., chronic obstructive pulmonary disease)
- •Body mass index (BMI) ≥ 35 kg/m²
- •Long-term use of steroids
- •Long-term use of analgesics
- •Inability to cooperate or communicate
- •Pregnancy
研究组 & 干预措施
Single-shot block with IV dexamethasone
Participants receive a single-shot ultrasound-guided interscalene brachial plexus block with 0.75% ropivacaine 15-20 mL, followed by intravenous dexamethasone 5 mg administered after confirmation of successful block on arrival in the operating room. Postoperatively, an intravenous patient-controlled analgesia (PCA) pump with fentanyl (10 mcg/mL, bolus 1 mL, lockout 6 min, no basal rate) is connected. All participants receive standard multimodal analgesia (intravenous acetaminophen 1000 mg plus ibuprofen 300 mg every 8 hours).
干预措施: Single-shot interscalene brachial plexus block (Procedure)
Continuous interscalene brachial plexus block
Participants receive an ultrasound-guided continuous interscalene brachial plexus block: 0.75% ropivacaine 15-20 mL is injected at the interscalene level, and a perineural catheter is placed with the tip adjacent to the superior trunk. Postoperatively, a nerve block PCA (0.2% ropivacaine, basal rate 5 mL/h, bolus 3 mL, lockout 30 min) is connected via the catheter. All participants receive the same standard multimodal analgesia as the experimental arm.
干预措施: Continuous interscalene brachial plexus block (Procedure)
Single-shot block with IV dexamethasone
Participants receive a single-shot ultrasound-guided interscalene brachial plexus block with 0.75% ropivacaine 15-20 mL, followed by intravenous dexamethasone 5 mg administered after confirmation of successful block on arrival in the operating room. Postoperatively, an intravenous patient-controlled analgesia (PCA) pump with fentanyl (10 mcg/mL, bolus 1 mL, lockout 6 min, no basal rate) is connected. All participants receive standard multimodal analgesia (intravenous acetaminophen 1000 mg plus ibuprofen 300 mg every 8 hours).
干预措施: Dexamethasone (IV) (Drug)
结局指标
主要结局
Rebound Pain Score (RPS)
时间窗: Within 24 hours after the nerve block
Difference between the last pain score recorded in the post-anesthesia care unit (PACU) while the nerve block is still effective and the highest pain score reported within the first 24 hours after the nerve block, measured on an 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Higher scores indicate more severe rebound pain. Non-inferiority margin: 1.5.
次要结局
- Postoperative pain score (NRS)(4, 8, 12, 24, and 48 hours after surgery)
- Peak NRS pain score(0-24 hours and 24-48 hours after surgery)
- Incidence of severe rebound pain(Within 24 hours after the nerve block)
- Block duration(Up to 48 hours after the nerve block)
- Time to first rescue analgesic(Up to 48 hours after surgery)
- Cumulative opioid consumption(24 and 48 hours after surgery)
- Block performance time(During the block procedure (day of surgery))
- Block failure rate(From block completion to start of surgery (day of surgery))
- Rescue block administration(Day of surgery)
- Intraoperative rescue analgesic use(During surgery)
- Conversion to general anesthesia(During surgery)
- Intraoperative sedative consumption(During surgery)
- Quality of Recovery-15 Korean version (QoR-15K) score(Baseline (day before surgery) and 24 hours after surgery)
- Incidence of postoperative nausea and vomiting (PONV)(4, 8, 12, 24, and 48 hours after surgery)
- Length of hospital stay(From surgery to discharge, up to 30 days)
- Patient satisfaction(48 hours after surgery)
- Incidence of hemidiaphragmatic paralysis(Within 24 hours after the nerve block)
- Postoperative blood glucose change(Postoperative day 1)
- Incidence of surgical and anesthetic complications(Up to 30 days after surgery)
研究者
Hansol Kim, MD
Clinical Associate Professor
Seoul National University Hospital