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临床试验/NCT01861665
NCT01861665终止不适用

A Comparative Trial of Marcaine Administration in Laparoscopic Gynecologic Surgery Using Either a Pre- or Post-operative Injection.

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
1
主要终点
Wong-Baker Faces Pain Rating Scale

研究概览

简要总结

The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.

详细描述

Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • Ages 18-50
  • BMI 20-35
  • Gynecologic ambulatory cases only
  • Total of 3 incisions, with left and right incisions both being 5mm-10mm in size
  • Not taking pain medications prior to surgery
  • Length of surgery up to 3 hours
  • PACU stay up to 6 hours
  • Willing and able to sign informed consent

排除标准

  • • Age or BMI out of range
  • Surgery longer than 3 hours or PACU stay longer than 6 hours
  • patients with chronic pelvic pain
  • Oncologic cases
  • Pregnant patients

研究组 & 干预措施

Marcaine administered pre-incision.

Active Comparator

Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.

干预措施: Marcaine- 0.25% (Drug)

Marcaine administered post-incision

Active Comparator

Marcaine 0.25% administered post-incision, total amount 5cc per incision.

干预措施: Marcaine 0.25%. (Drug)

结局指标

主要结局

Wong-Baker Faces Pain Rating Scale

时间窗: Post surgery day 0, post surgery day 1, post surgery day 2

Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Marcaine Use in Laparoscopic Gynecological Surgery | 临床试验