Analgesic Effect of Subcutaneous Local Infiltration Anesthesia Before Skin Closure on Postoperative Pain in Patients Undergoing Orthopedic Wide Excision: A Prospective Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- Cumulative Opioid Consumption Within 24 Hours After Surgery
研究概览
简要总结
This study evaluates whether injecting a local anesthetic mixture (ropivacaine, morphine, ketorolac, and epinephrine) under the skin at the incision site before wound closure reduces pain after orthopedic wide excision surgery for bone or soft tissue tumors. Participants will be randomly assigned to receive either the local anesthetic mixture or a saline control injection. Neither participants nor the study team assessing outcomes will know which treatment was given. The main goal is to determine whether this injection reduces the amount of opioid pain medication needed during the first 24 hours after surgery. The study will also assess pain scores, nausea and vomiting, and quality of recovery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo elective orthopedic wide excision surgery under general anesthesia
- •American Society of Anesthesiologists (ASA) Physical Status Classification 1, 2, or 3
- •Age 19 years or older
排除标准
- •Unwilling to provide informed consent
- •History of allergy to local anesthetics
- •History of chronic pain
- •Use of opioid analgesics within 24 hours before surgery
- •Active infection at the surgical site
研究组 & 干预措施
Local Anesthetic Infiltration Group
Participants receive a subcutaneous/subfascial injection at the incision site before skin closure, containing 0.75% ropivacaine 20 mL, morphine 10 mg, ketorolac 30 mg, epinephrine 0.3 mg, and cefuroxime 750 mg (total 50 mL).
干预措施: Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture (Combination Product)
Placebo Control Group
Participants receive a subcutaneous/subfascial injection at the incision site before skin closure, containing cefuroxime 750 mg and normal saline (total 50 mL).
干预措施: Cefuroxime-Saline Mixture (Drug)
结局指标
主要结局
Cumulative Opioid Consumption Within 24 Hours After Surgery
时间窗: 24 hours after surgery
Total opioid consumption during the first 24 hours postoperatively, converted to intravenous morphine milligram equivalents (MME).
次要结局
未报告次要终点
研究者
Chang-Hoon Koo
Clinical Associate Professor
Seoul National University Hospital