Effect of Intraplexus and Extraplexus Interscalene Block Approaches on the Incidence of Rebound Pain in Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Rebound pain
研究概览
简要总结
In this study, the hypothesis that local anesthesia, not directly injected into the nerve root, may reduce the incidence of rebound pain in the interscalene block with an extraplexus approach during arthroscopic shoulder surgeries will be investigated. Rebound pain is defined as a short-term but severe pain before and after the resolution of the interscalene block and will be evaluated using the Numerical Rating Scale (NRS) (NRS ≥ 7).
详细描述
The study will include patients aged 18-65 years, with an American Society of Anesthesiologists (ASA) physical status of I or II, scheduled for arthroscopic shoulder surgery in the lateral decubitus position, accompanied by interscalene nerve block performed by the same surgeon. Patient characteristics (age, gender, body mass index, etc.), block procedure duration, number of needle passes, onset time of sensory block, onset time of motor block, and possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness), postoperative nausea and vomiting (PONV) status, and Quality of Recovery-15 (QoR-15) scores on the preoperative first day and postoperative days 1 and 7 will be recorded. The primary outcome parameter will be the incidence of rebound pain. Rebound pain will be defined as a short-term but severe pain before and after the resolution of the interscalene block, assessed using the Numerical Rating Scale (NRS) (NRS ≥ 7). Secondary outcomes will include the number of needle passes, block application time, onset time of sensory block, onset time of motor block, intraoperative dexmedetomidine requirement, duration of block effectiveness, postoperative pain, PONV, need for rescue analgesics, incidence of paresthesia and Horner's syndrome, dyspnea, hoarseness, duration of stay in the recovery room, duration of rebound pain, and postoperative Quality of Recovery-15 (QoR-15) scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years.
- •Patients with ASA physical status I or II.
- •Patients planned for arthroscopic shoulder surgery in the lateral decubitus position with interscalene nerve block.
排除标准
- •Patients who do not consent to participate in the study.
- •Block failure.
- •Language acquisition deficiency.
- •Obesity (body mass index > 35 kg/m²).
- •Diabetes.
- •Psychiatric disorders.
- •Central nervous system diseases.
- •Vestibular diseases.
- •Presence of neuropathy and paralysis.
- •Pregnancy.
- •Previous open shoulder surgery.
- •Allergy to local anesthetics.
- •Coagulopathy.
- •Severe thrombocytopenia.
- •Infection at the puncture site.
- •Pre-existing neuropathy in the limb to be operated.
- •Use of dexamethasone.
- •Use of opioid and antiemetic medications before surgery.
- •Severe cardiopulmonary disease.
- •Low baseline oxygen saturation.
- •Conditions that prevent cooperation in the postoperative period (e.g., mental retardation, delirium).
研究组 & 干预措施
Intraplexus approach in interscalene block
The block needle will be advanced from the middle scalene muscle in a posterior-anterior direction and advanced between the C5-C6 nerve roots and the injection will be performed
干预措施: Intraplexus (Other)
Extraplexus approach in interscalene block
The block needle will first be advanced above the C5 nerve root and towards the anterior part of the brachial plexus and 10 ml of local anesthetic will be injected. Then, the needle will be withdrawn to the posterior surface of the brachial plexus and 10 ml of local anesthetic will be administered.
干预措施: Extraplexus (Other)
结局指标
主要结局
Rebound pain
时间窗: 36 hours
Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Rebound pain will be defined as a short-term but severe pain occurring before and after the resolution of the interscalene block (NRS ≥ 7).
次要结局
- Block performance time(During the block procedure time)
- Number of needle passes(During the block procedure time)
- Rescue analgesic(36 hours)
- Duration of rebound pain(36 hours)
- Onset of sensory block(Preoperative time)
- Onset of motor block(Preoperative time)
- Duration of block effectiveness(36 hours)
- PONV(36 hours)
- Paresthesia(During the block procedure time)
- Horner's syndrome(Perioperative/Periprocedural)
- Dyspnea(Perioperative/Periprocedural)
- Hoarseness(Perioperative/Periprocedural)
- Intraoperative use of dexmedetomidine(Intraoperative time)
- Pain scores(36 hours)
- Duration of stay in the recovery room(up to 2 hours post surgery)
- Quality of recovery(Preoperative day 1, postoperative days 1 and 7.)
研究者
Gökhan Erdem
Anesthesiology and Reanimation specialist doctor
Ankara City Hospital Bilkent