Impact of Pre-incisional Wound Infiltration and Hypogastric Plexus Block Using Ropivacaine on Postoperative Pain Following Laparoscopic Myomectomy: A Single-Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
The purpose of this study is to assess an impact of laparoscopic superior hypogastric plexus (SHP) block combined with preemptive troacar site infiltration on postoperative pain intensity following laparoscopic myomectomy.
详细描述
Patients randomized into 3 groups with a target ratio of 1:1:1 were included in the study: group 1 received standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block; group 2 received troacar site infiltration without SHP block; control group (group 3) received standard systemic analgesia alone. The primary endpoint was presented by assessing pain intensity using the numeric rating scale (NRS) at 4 hours postoperatively. Secondary endpoints included NRS dynamics at 2, 6, 8, 12, and 24 hours postoperatively, time to first mobilization, opioid use, and pain quality assessment.
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
- Double (Participant, Care Provider)
盲法说明
All patients and clinicians involved in the study are unaware of the group assignment and syringe contents.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18 years.
- •Indication for laparoscopic myomectomy due to ≥6 cm fibroid(s) or multiple fibroids.
- •Ability to provide informed consent.
排除标准
- •FIGO type 7 subserosal pedunculated myoma.
- •Conversion to laparotomy.
- •Severe presacral adhesions preventing safe SHPB.
- •Concomitant pelvic or abdominal surgery.
研究组 & 干预措施
Standart analgesia
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
干预措施: Troacar site infiltration (Procedure)
Standart analgesia
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
干预措施: Superior hypogastric plexus block (Procedure)
Troacar site infiltration
Troacar site infiltration without SHP block
干预措施: Troacar site infiltration (Procedure)
Troacar site infiltration
Troacar site infiltration without SHP block
干预措施: Superior hypogastric plexus block (Procedure)
SHP block
Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block
干预措施: Superior hypogastric plexus block (Procedure)
SHP block
Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block
干预措施: Troacar site infiltration (Procedure)
结局指标
主要结局
Pain Score
时间窗: 4 hours postoperatively
Pain syndrome intensity 4 hours after laparoscopic myomectomy. The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable.
次要结局
- Opioid Use(Postoperative period, up to 48 hours)
- Pain Score Dynamics(2, 6, 8, 12, and 24 hours postoperatively)
- Mobilization(Early postoperative period)
- Pain Localisation (Superficial/Deep)(Within 48 hours after surgery)
研究者
Nikita Kharlov
Head of Gynecology department
Saint Petersburg State University, Russia