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临床试验/NCT03792009
NCT03792009Unknown不适用

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Paracervical Block Before Total Laparoscopic Hysterectomy for Postoperative Pain Control (PALAPA):

Kangbuk Samsung Hospital3 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年2月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
86
试验地点
3
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 total laparoscopic hysterectomy (TLH), 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 TLHs for benign gynecologic conditions on postoperative pain relief.

详细描述

Postoperative pain management is an important component of patient care and satisfaction after surgery. Although contemporary changes such as a shift to minimally invasive approaches and an introduction of the enhanced recovery after surgery (ERAS) program have resulted in improved outcomes, a large number of patients undergoing surgery have still inadequate pain control. Paracervical block is a single-injection of anesthetic around the cervix at a depth of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing through Frankenhäuser plexus. Moreover, recent randomized trials demonstrated that patients who underwent vaginal hysterectomy and received a paracervical block had lower postoperative pain in the first 3-6 hours compared with placebo.

However, it remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), 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 TLHs for benign gynecologic conditions on postoperative pain relief.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age between 18 and 65 years
  • 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 procedures (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

Experimental

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

Experimental

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

Placebo Comparator

The paracervical injection with 10 mL of normal saline 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 normal saline

Placebo Comparator

The paracervical injection with 10 mL of normal saline 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: 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

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Taejong Song

Professor

Kangbuk Samsung Hospital

研究点 (3)

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