The Effect of Vaginal Cuff Bupivacaine Injection on Postoperative Pain After Vaginal Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
This randomized controlled study evaluates whether injecting bupivacaine into the vaginal cuff during vaginal hysterectomy reduces postoperative pain. Vaginal hysterectomy is commonly performed for benign gynecologic conditions. Although it is associated with less pain compared to abdominal surgery, postoperative discomfort may still affect recovery and patient satisfaction.
In this study, 48 women undergoing elective vaginal hysterectomy were randomly assigned to two groups. In the intervention group, 0.25% bupivacaine was injected bilaterally into the vaginal cuff after closure. In the control group, no local anesthetic injection was administered. All patients received the same standard postoperative pain management protocol.
Pain levels were measured using the Visual Analog Scale (VAS) at 1, 3, 6, 12, and 24 hours after surgery. Additional analgesic consumption and possible complications were also recorded. The study aims to determine whether vaginal cuff bupivacaine infiltration improves early postoperative pain control.
详细描述
This prospective, single-center, randomized controlled trial was conducted to evaluate the effect of bilateral vaginal cuff infiltration with 0.25% bupivacaine on postoperative pain following vaginal hysterectomy performed for benign gynecologic indications.
Vaginal hysterectomy, although minimally invasive, may still be associated with significant postoperative discomfort. The uterus and surrounding structures receive innervation from the uterosacral plexus (Lee-Frankenhauser plexus), which plays a role in postoperative pain transmission. Local anesthetic infiltration targeting this anatomical region may reduce nociceptive signaling and improve early postoperative pain control.
A total of 48 women aged 35-75 years scheduled for elective vaginal hysterectomy were randomized using a sealed-envelope method into two parallel groups:
Intervention group (n=24): Bilateral infiltration of 10 mL 0.25% bupivacaine into the lateral aspects of the vaginal cuff following cuff closure.
Control group (n=24): Standard surgical procedure without local anesthetic infiltration.
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
- Single (Participant)
盲法说明
Single-blind study. Participants were blinded to group allocation. The surgeon and clinical staff were aware of the treatment assignment due to the nature of the intervention.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 35 to 75 years
- •Scheduled for elective vaginal hysterectomy for benign gynecologic indications (e.g., uterine fibroids, adenomyosis, abnormal uterine bleeding, pelvic organ prolapse)
- •Able to provide written informed consent
排除标准
- •Known or suspected gynecologic malignancy (endometrial, cervical, or uterine)
- •Allergy or hypersensitivity to local anesthetics, especially bupivacaine
- •Prior pelvic radiotherapy or major pelvic surgery resulting in altered anatomy
- •Conditions preventing vaginal cuff injection (e.g., extensive scarring, active infection)
- •Inability to reliably assess pain (e.g., impaired consciousness, dementia, severe psychiatric disorder)
- •Refusal to sign informed consent
研究组 & 干预措施
Bupivacaine Injection Group
Participants in this group underwent standard vaginal hysterectomy. After vaginal cuff closure, bilateral infiltration of 10 mL 0.25% bupivacaine was administered to the lateral aspects of the vaginal cuff. All patients received the standard postoperative analgesia protocol.
干预措施: Bupivacaine %0.25 (isobaric) (Drug)
Control Group
Participants in this group underwent standard vaginal hysterectomy without local anesthetic infiltration of the vaginal cuff. All patients received the same standard postoperative analgesia protocol.
结局指标
主要结局
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: 1, 3, 6, 12, and 24 hours postoperatively
Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration
次要结局
未报告次要终点
研究者
Havva Betül Bacak
md
Gaziosmanpasa Research and Education Hospital