Liposomal Bupivacaine vs Ropivacaine for Post-hemorrhoidectomy Analgesia
Liposomal Bupivacaine Versus Ropivacaine for Wound Infiltration Analgesia After Milligan-Morgan Open Hemorrhoidectomy: A Randomized Controlled Trial
研究概览
地位
详细说明
Milligan-Morgan open hemorrhoidectomy is associated with substantial postoperative pain due to rich somatic innervation of the perianal region, wound exposure, anal sphincter spasm, and stimulation during defecation. Optimizing postoperative analgesia is critical for enhanced recovery. Local wound infiltration with ropivacaine is commonly used but provides limited duration of analgesia. Liposomal bupivacaine, formulated with a multivesicular liposomal delivery system, enables sustained release of bupivacaine at the injection site and may prolong local analgesia. However, high-quality comparative evidence between liposomal bupivacaine and ropivacaine for wound infiltration after open hemorrhoidectomy remains limited.
This single-center, prospective, randomized, double-blind controlled trial enrolled patients aged 18-60 years with grade III-IV internal hemorrhoids or mixed hemorrhoids scheduled for elective Milligan-Morgan open hemorrhoidectomy at Tongliao People's Hospital between November 2025 and May 2026. Patients were randomized 1:1 to receive perianal wound infiltration with either 266 mg of liposomal bupivacaine or 200 mg of ropivacaine hydrochloride, both diluted to 30 mL with normal saline and divided into six 5-mL aliquots infiltrated at six predefined perianal clock-face positions. All patients received spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Rescue analgesia with oral diclofenac sodium 50 mg was provided when VAS pain score was ≥4.
The primary outcome is resting VAS pain score at 24 hours postoperatively. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative diclofenac sodium consumption during postoperative days 1-3, QoR-40 total scores on postoperative days 1-3, and adverse events (nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, surgical-site infection) within 72 hours.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Xiaona Liu
- 电话号码:+8615894886794
- 邮箱:15894886794@163.com
研究联系人备份
- 姓名:Yucheng Tian
- 电话号码:+8615942988130
- 邮箱:3216134807@qq.com
学习地点
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Tongliao
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Neimeng、Tongliao、中国、028000
- Tongliao People's Hospital
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接触:
- Bo Sun
- 电话号码:0475-82511603
- 邮箱:tlsyybgs@163.com
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 1. Aged 18-60 years, irrespective of sex 2. Diagnosed with grade III-IV internal hemorrhoids or mixed hemorrhoids based on specialist examination and scheduled to undergo elective Milligan-Morgan open hemorrhoidectomy 3. American Society of Anesthesiologists (ASA) physical status I-III 4. Body mass index (BMI) of 18.0-30.0 kg/m² 5. Able to understand and complete the pain and quality-of-recovery assessments and willing to participate in the study
Exclusion Criteria:
1. Concomitant chronic low back or leg pain, anal fissure, perianal abscess, or other persistent painful conditions 2. Pregnancy, breastfeeding, or plans to become pregnant in the near future 3. Known allergy to bupivacaine, ropivacaine, or any other medication used during the study 4. Long-term regular use of opioids or use of analgesic medications within 48 hours before surgery 5. Obstructive sleep apnea syndrome or severe cardiovascular, cerebrovascular, or pulmonary disease considered to significantly increase risks associated with neuraxial anesthesia or postoperative analgesia 6. Psychiatric or cognitive impairment that precludes completion of study assessments 7. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation
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学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Liposomal Bupivacaine Group
Patients receive perianal wound infiltration with 266 mg of multivesicular liposomal bupivacaine (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL.
The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery.
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266 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
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有源比较器:Ropivacaine Group
Patients receive perianal wound infiltration with 200 mg of ropivacaine hydrochloride (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL.
The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery.
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200 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Resting visual analog scale (VAS) pain score
大体时间:48 hours after surgery
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Pain intensity at rest assessed using a 10-cm VAS, with 0 indicating no pain and 10 indicating the worst imaginable pain.
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48 hours after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Resting and movement-evoked VAS pain scores
大体时间:4, 6, 12, 24, and 48 hours after surgery
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Pain intensity at rest and during movement assessed using a 10-cm VAS at predefined postoperative time points.
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4, 6, 12, 24, and 48 hours after surgery
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Cumulative rescue analgesic consumption
大体时间:Postoperative days 1-3 (within 72 hours)
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Cumulative dose of oral diclofenac sodium (mg) consumed as rescue analgesia when VAS pain score ≥4.
Maximum daily dose 150 mg, minimum interval 8 hours
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Postoperative days 1-3 (within 72 hours)
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Quality of Recovery-40 (QoR-40) total score
大体时间:Postoperative days 1, 2, and 3
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The QoR-40 comprises 40 items across five dimensions (physical comfort, emotional state, physical independence, psychological support, and pain).
Total scores range from 40 to 200, with higher scores indicating better postoperative recovery.
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Postoperative days 1, 2, and 3
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Incidence of adverse events
大体时间:Within 72 hours after surgery
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Adverse events including nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, and surgical-site infection
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Within 72 hours after surgery
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TongliaoCPH
- 337087 (注册表标识符:China Clinical Trial Registration Center)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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