Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery:A Single-Center, Prospective, Randomized, and Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- pain score at rest
研究概览
简要总结
Prospective, randomized, and controlled trial to compare the postoperative pain management of paravertebral nerve block with liposomal bupivacaine to ropivacaine in patients undergoing elective thoracoscopic surgery.
详细描述
The objective of this study is to validate the analgesic efficacy of liposomal bupivacaine (LB) compared with ropivacaine when injected for paravertebral nerve block (PVB) for video-assisted thoracoscopic surgery (VATS).
We hypothesize that LB will be superior to ropivacaine in terms of postoperative pain control following VATS. The primary outcome of this study will be NRS pain scores for resting pain and NRS pain scores for cough pain 24 hours following surgery. Secondary outcomes will include pain scores over the first 120 hours following surgery, opioid consumption, opioid-related adverse events, block-related adverse events, time of first getting out of bed, catheter indwelling time, postoperative hospitalization time, patient satisfaction, and chronic pain at 1, 3, and 6 months after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64 years old
- •Elective unilateral thoracoscopic surgery
- •Hospital stay ≥3 days
- •Able to cooperate in completing interviews and scale assessments
- •American Society of Anesthesiologists (ASA) classification I-III
- •Signed informed consent form
排除标准
- •History of thoracic surgery within the past 6 months
- •Pre-existing history of chronic pain or acute pain in the surgical area
- •Allergy to local anesthetics
- •Contraindications to thoracic paravertebral nerve block
- •Mental disorders, intellectual disabilities, epilepsy, or other neurological conditions
- •Severe heart or lung diseases
- •History of opioid drug abuse or substance abuse
- •Postoperative intubation
- •Recent participation in other clinical studies
研究组 & 干预措施
Drug: Liposomal bupivacaine
Experimental group will receive PVB with LB 20 mL.
干预措施: Liposomal bupivacaine (Drug)
Drug:ropivacaine
Comparator group will receive PVB with 20 mL of 0.5% ropivacaine
干预措施: Ropivacaine (Drug)
结局指标
主要结局
pain score at rest
时间窗: 24 hours after surgery
The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
pain score during coughing
时间窗: 24 hours after surgery
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
次要结局
- pain score during coughing(120 hours after surgery)
- Nerve block related adverse events(120 hours after surgery)
- Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.(3 months after surgery)
- pain score at rest(120 hours after surgery)
- Consumption of analgesic drugs(120 hours after surgery)
- Block duration: first reported pain(24 hours after surgery)
- Presence of pain 1 month after surgery assessed using the Brief Pain Inventory.(1 month after surgery)
- Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.(6 months after surgery)
- Hospital Anxiety and Depression Scale, HADS(day1 before surgery)
- Mini-cog(day1 before surgery)
- Charlson Comorbidity Index, CCI(day1 before surgery)
- Insomnia Severity Index, ISI(day1 before surgery)
- Complications within 120hours after surgery(Five days after surgery)
- The douleur neuropathique 4 questionnaire(DN4)(6 months after surgery)
研究者
Feng Gao
Professor
Tongji Hospital