Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in laparoscopic myomectomy (LM), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to LM for benign gynecologic conditions on postoperative pain relief.
详细描述
However, no study investigating the efficacy of paracervical block in laparoscopic myomectomy on postoperative pain was conducted, to date. Therefore, the goal of this study is to evaluate whether patients who receive a paracervical block of 5% bupivacaine with epinephrine at the time of laparoscopic myomectomy would have lower postoperative pain, with less consumption of rescue analgesics than patients who receive a paracervical block of normal saline.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Uterine myoma
- •American Society of Anesthesiologists physical status (ASAPS) classification I-II
- •The absence of pregnancy at the time of surgery.
排除标准
- •history of cervical surgery such as conization or cerclage
- •inability to perform the paracervical block due to anatomical abnormalities (i.e., very atrophic or small cervix)
- •allergy to bupivacaine, planned concomitant surgical procedures involving extensive additional tissue manipulation such as pelvic lymph node dissection
- •any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or sacrocolpopexy) or vaginal procedure (anterior or posterior colporrhaphy or mid-urethral slings)
- •previously taking opioids for chronic pain
- •inability to accurately express their pain
研究组 & 干预措施
Paracervical block with 5% bupivacaine
The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
干预措施: Paracervical block (Device)
Paracervical block with 5% bupivacaine
The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
干预措施: 5% bupivacaine (Drug)
Paracervical block with normal saline
ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
干预措施: Paracervical block (Device)
Paracervical block with normal saline
ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
干预措施: Normal saline (Drug)
结局指标
主要结局
Postoperative pain
时间窗: at 6-hour after surgery
The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".
次要结局
- Frequency of pills/injections requested(Within 24-hour after surgery)
研究者
Taejong Song
Professor
Kangbuk Samsung Hospital