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临床试验/NCT03427840
NCT03427840Unknown不适用

Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy

Derince Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
postoperative pain scores (PACU)

研究概览

简要总结

The primary indication for superior hypogastric plexus (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Per-cutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. During minimally invasive laparoscopic surgery, percutaneous technique can be done under the guidance of cameras.

详细描述

Laparoscopic surgeries have many advantages over open surgeries. Laparoscopic procedures are mostly preferred for surgical treatment of gynecologic diseases, because of best cosmetically results, less perioperative complications, early recovery, and less postoperative pain.

There are many undesirable effects of systemic reactions to the pain. Accordingly, multi-modal analgesic approach (including nerve blocks) for postoperative acute pain can decrease the side effects of the drugs (especially opioids) significantly.

The primary indication for superior hypogastric plexus (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Per-cutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. During minimally invasive laparoscopic surgery, per-cutaneous technique can be done under the guidance of cameras.

SHP block has been performed by anesthetists or surgeons in Kocaeli Derince Training and Research Hospital regularly since they have discovered the advantages of this block technique. SHP can be useful to decrease postoperative pain scores and opioid or NSAID consumption significantly.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • ASA I - II
  • Elective laparoscopic hysterectomy

排除标准

  • Different kind of surgery
  • Known allergy to local anesthetic drugs
  • Different analgesia protocol (ie: epidural, TAP block,..)
  • Refusal of the patient

结局指标

主要结局

postoperative pain scores (PACU)

时间窗: 1 hour (postoperatively)

Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever)

postoperative opioid/NSAID consumption (PACU)

时间窗: 1 hour (postoperatively)

nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.

rescue analgesic time

时间窗: 48 hours (first analgesic demand time will be noted down)

Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)

postoperative pain scores (ward)

时间窗: 48 hours (postoperatively)

Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever)

postoperative opioid/NSAID consumption (ward)

时间窗: 48 hours (total)

NSAID or opioid drugs that are applied to patients will be noted down. Target VAS score for NSAID is \>4; if there is no response to NSAID and pain is worsening opioid drugs will be applied

次要结局

  • Intraoperative hemodynamics(from SHP block to the end of the surgery (approximately 15 min))
  • length of stay(3-5 days (expected))
  • complications due to SHP block(3-5 days (from surgery to discharge from the hospital))

研究者

发起方
Derince Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hande G. Aytuluk

M.D., Principal investigator

Derince Training and Research Hospital

研究点 (1)

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