Interscalene Brachial Plexus Block is Associated With Lower Patient-Reported Wound Symptom Scores and Altered Perioperative Biomarker Profiles Following Open Rotator Cuff Repair: An Exploratory Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- interscalene block
研究概览
简要总结
This exploratory randomized controlled trial evaluated the association of interscalene brachial plexus block (ISB) with early postoperative wound-related symptom scores and perioperative biomarker responses in patients undergoing open rotator cuff repair.
Participants were randomly allocated to receive either ultrasound-guided interscalene brachial plexus block or standardized general anaesthesia. The primary outcome was postoperative wound-related assessment using the Toronto Symptom Assessment System for Wounds (TSAS-W) on postoperative days 5 and 14. TSAS-W was used as an exploratory patient-reported wound symptom assessment tool.
Secondary outcomes included perioperative serum cytokine and growth-factor concentrations (IL-1β, IL-2, TNF-α, EGF, PDGF, and TGF-β), platelet counts, postoperative pain scores, tramadol consumption within 48 hours, time to mobilisation, and postoperative nausea and vomiting.
This study aimed to investigate whether interscalene brachial plexus block was associated with differences in perioperative biological responses and postoperative wound-related symptom scores compared with general anaesthesia.
详细描述
Study Design and Participants
This prospective, parallel-group randomized controlled trial included adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who were scheduled for elective open rotator cuff repair.
Participants were randomly allocated in a 1:1 ratio to receive either ultrasound-guided interscalene brachial plexus block (ISB) or general anaesthesia (GA). Randomization was performed using a computer-generated block randomization sequence with a fixed block size of four. Allocation concealment was achieved using sequentially numbered opaque sealed envelopes prepared by an investigator not otherwise involved in patient care or outcome assessment.
Due to the nature of the intervention, participants and the attending anaesthesiologist were not blinded. The operating surgeon was aware of group allocation because of the visible differences in perioperative anaesthetic management. However, laboratory personnel, postoperative outcome assessors, postoperative care staff, and the statistician remained blinded to group allocation whenever feasible.
A total of 34 participants were randomized. Two participants in the general anaesthesia group were excluded after randomization (one protocol violation and one missing follow-up), leaving 32 participants (GA n=15; ISB n=17) for per-protocol analysis.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors, laboratory personnel, postoperative care staff, and the statistician were blinded to treatment allocation whenever feasible. Due to the nature of the intervention, participants and attending anaesthesiologists were not blinded.
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
- •Adult patients aged 18-65 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective open repair of a full-thickness rotator cuff tear
排除标准
- •Pregnancy or lactation
- •Known coagulopathy
- •Chronic renal insufficiency
- •Chronic hepatic insufficiency
- •Significant uncontrolled cardiopulmonary disease
- •Chronic opioid use
- •Immunosuppressive therapy
- •Diabetes mellitus or other uncontrolled metabolic disorders potentially affecting wound healing
- •Chronic inflammatory disease
- •Morbid obesity (body mass index ≥35 kg/m²)
- •Allergy to amide local anaesthetics
- •Infection at the injection site
- •Emergency surgery
- •Inability to complete postoperative assessments
研究组 & 干预措施
General Anesthesia Group
Patients undergoing open rotator cuff repair under standardized general anaesthesia. General anaesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane. Additional intraoperative fentanyl was administered according to haemodynamic responses. Postoperative analgesia included paracetamol and rescue tramadol.
干预措施: General Anesthesia (Procedure)
Interscalene Block Group
Patients undergoing open rotator cuff repair with ultrasound-guided interscalene brachial plexus block using 20 mL of 0.25% bupivacaine. Surgery was performed under awake regional anaesthesia without routine sedation. Supplemental intravenous fentanyl boluses were permitted intraoperatively if clinically required according to predefined haemodynamic criteria.
Postoperative analgesia included paracetamol and rescue tramadol.
干预措施: Ultrasound-Guided Interscalene Brachial Plexus Block (Procedure)
结局指标
主要结局
interscalene block
时间窗: 6 monthes
number of participants with interscalene block
Early postoperative wound-related symptom scores (TSAS-W)
时间窗: Postoperative day 5 and day 14
Early postoperative wound-related symptoms assessed using the Toronto Symptom Assessment System for Wounds (TSAS-W), a patient-reported wound symptom assessment tool originally developed for chronic wound settings. TSAS-W was used as an exploratory patient-reported symptom assessment instrument rather than as an objective measure of wound healing.
次要结局
- general anesthesia(6 monthes)
- Postoperative nausea and vomiting(Within 48 hours postoperatively)
- Time to mobilisation(Up to 48 hours after surgery)
- Postoperative tramadol consumption(Within 48 hours postoperatively)
研究者
Arzu Esen Tekeli
Associate Professor
Yuzuncu Yil University