Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 535
- 试验地点
- 1
- 主要终点
- postoperative sufentanil consumption via PCA
研究概览
简要总结
Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).
- •Patients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.
排除标准
- •Patients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI<15kg/m2 or>35 kg/m
- •Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score < 15 before surgery. Unable to provide written informed consent.
- •Withdrawal criteria:
- •Voluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.
- •Reoperation during follow-up.
研究组 & 干预措施
intervention group 1
0.012%diprospan+0.5%ropivacaine
干预措施: 0.012%diprospan+0.5%ropivacaine (Drug)
intervention group 2
0.009%diprospan+0.5%ropivacaine
干预措施: 0.009%diprospan+0.5%ropivacaine (Drug)
intervention group 3
0.006%diprospan+0.5%ropivacaine
干预措施: 0.006%diprospan+0.5ropivacaine (Drug)
intervention group 4
0.003%diprospan+0.5%ropivacaine
干预措施: 0.003%diprospan+0.5%ropivacaine (Drug)
control group
0.5%ropivacaine
干预措施: 0.5%ropivacaine (Drug)
结局指标
主要结局
postoperative sufentanil consumption via PCA
时间窗: At 48 hours after the operation
The cumulative 48 hours postoperative sufentanil consumption via PCA was the primary outcome of our study
次要结局
- Cumulative consumption of sufentanil by PCA(During 0-4hours, 4-8hours, 8-24hours and 24-48hours after operation)
- PCA pump first press time(Within 48 hours after the operation.)
- VAS score at during movement (VASm) and at rest (VASr)(At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively)
- Intraoperative opioid dosage(During the operation)
- Time to first analgesic remediation(Until 3 months after surgery)
- Amount of postoperative oral analgesic remediation(Until 3 months after surgery)
- Postoperative nausea and vomiting (POVN)(At 2hours, 4hours, 8hours, 24hours, and 48hours postoperatively)
- Ramsay sedation score (RSS)(At 2hours, 4hours, 8hours, 24hours, 48hours postoperatively)
- Satisfaction score(At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively)
- The World Health Organization Quality of Life (WHOQOL)(At 3months postoperatively)
- Oswestry disability index (ODI)(At 3months postoperatively)
- Patient and Observer Scar Assessment Scale (POSAS)(At 3months postoperatively)
- Adverse events(At 3months postoperatively)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital