Effect of Modified Bilateral Arm Wrapping Position on Postoperative Ipsilateral Shoulder Pain in Patients Undergoing Video-Assisted Thoracoscopic Lobectomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Incidence of Ipsilateral Shoulder Pain Within 24 Hours Postoperatively
研究概览
简要总结
This study is a prospective randomized controlled trial aiming to reduce shoulder pain after lung surgery. Shoulder pain on the surgical side is common after video-assisted thoracoscopic lobectomy, affecting about 20%-58% of patients. It can limit coughing, moving, and sleeping, and may delay recovery.
The pain may come from two sources: nerve stimulation during surgery and the prolonged arm position used during the operation. While nerve stimulation is hard to avoid, the arm position can be modified. Currently, most pain treatments rely on medications or nerve blocks given after surgery, which have side effects or risks. No one has tried to prevent the pain by changing the arm position during the operation.
We plan to enroll 270 patients scheduled for thoracoscopic lung removal surgery at Chengdu Shangjin Nanfu Hospital. Patients will be randomly divided into two groups. One group will receive the standard side-lying position with arms extended on arm boards (traditional position). The other group will receive a modified position where both arms are bent at the elbows and wrapped with surgical drapes, without using arm boards (modified double-arm wrap position).
Our main goal is to compare the rate of shoulder pain (on the operated side) within 24 hours after surgery between the two groups. We will also compare pain on the opposite shoulder, pain severity, time needed to set up the position, total surgery time, hospital stay, and any nerve or skin complications.
This study has been approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University. All participants will provide written informed consent. The findings may help improve intraoperative positioning and enhance early recovery after lung surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Diagnosed with pulmonary space-occupying lesion and scheduled for elective video-assisted thoracoscopic standard lobectomy.
- •ASA physical status classification I-III.
- •No pre-existing shoulder pain or shoulder mobility impairment prior to surgery.
- •No long-term use of analgesic medications (>1 week) before surgery.
- •Willing and able to provide written informed consent.
排除标准
- •Severe cervical spine disease or history of brachial plexus injury.
- •Cognitive impairment or psychiatric disorder precluding understanding of pain assessment scales.
研究组 & 干预措施
Modified Bilateral Arm-Wrapping Position
干预措施: Modified Double-Arm Wrap Positioning (Other)
Traditional Arm-Board Position
干预措施: Traditional Arm-Board Position (Other)
结局指标
主要结局
Incidence of Ipsilateral Shoulder Pain Within 24 Hours Postoperatively
时间窗: Within the first 24 hours after surgery
次要结局
- Postoperative Hospital Stay(At hospital discharge)
- Incidence of Brachial Plexus Injury-Related Signs Within 72 Hours Postoperatively(Within 72 hours postoperatively)
- Position-related pressure injury within 72 h(From the end of surgery to 72 hours postoperatively)
- Positioning Setup Time(Intraoperative recording)
- Incidence of Contralateral Shoulder Pain Within 24 Hours Postoperatively(Within the first 24 hours after surgery (Postoperative Day 1, 0-24 hours))
- VAS scores for Ipsilateral Shoulder Pain at rest and on movement at 24 h postoperatively.(At 24 hours postoperatively)
- incidence of ipsilateral shoulder pain at postoperative day 3(Postoperative Day 3)
- Total Surgical Duration(Intraoperative recording)
研究者
Fei Jia
Director of Anesthesiology Department
Chengdu Jinjiang Maternity and Child Health Hospital