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临床试验/NCT01492179
NCT01492179已完成4 期

A Comparison Between Continuous Infusion vs. Patient Controlled Intraabdominal Injection of Local Anesthetics for Treatment of Postoperative Pain After Abdominal Hysterectomy. A Randomized, Double-blind Study.

Örebro University, Sweden1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.

详细描述

Abdominal hysterectomy with or without salipingo-oophorectomy is associated with moderate-severe postoperative pain. Poor pain control in the postoperative period can lead to increased postoperative morbidities and poor quality of life. Furthermore, an emerging clinical literature suggests that acute pain may rapidly evolve into chronic pain if poorly treated. A meta-analysis of the literature found that > 30% patients had chronic pain one year after abdominal hysterectomy (5). Therefore, efficient postoperative pain management is imperative for the patient and is one of the new pain management standards recommended recently.

Local anesthetics (LA) have been infiltrated subcutaneously, infused intra-abdominally, as well as injected into the peritoneal cavity as a single dose at the end of the operation following abdominal hysterectomy with variable effects. When injected as a single dose, analgesia is limited to approximately 2-4 hours due to the short duration of action of local anesthetics. In one recent study, the authors used a catheter inserted intra-abdominally and local anesthetic or placebo infusion into the abdominal cavity for 24 h postoperatively and found a reduction in postoperative analgesic requirements by 40% during 4-24 h. In another study, the investigators found that LA injected intermittently intra-abdominally resulted in better pain relief compared to intra-abdominal infusions.

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
30 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 30 - 75 yrs
  • Informed consent
  • 50 - 100 kg

排除标准

  • Allergy to LA
  • Chronic pain
  • Major liver/kidney insufficiency
  • AV Block 1-2 Participation in another clinical trial

研究组 & 干预措施

Intravenous Lidocaine

Active Comparator

Intravenous lidocaine would be administered as an infusion for pain management both intra- and post-operatively.

干预措施: Intravenous Lidocaine (Drug)

Intra-abdominal Lidocaine

Active Comparator

Lidocaine would be administered intermittently, once each hour intra-abdominally for postoperative pain management.

干预措施: Intra-abdominal Lidocaine (Drug)

Normal saline

Placebo Comparator

Normal saline would be administered intra-abdominally and intravenously in the same patient. Rescue analgesia in the form of morphine (PCA) would be used for pain management.

干预措施: Normal saline (Drug)

结局指标

主要结局

Morphine consumption

时间窗: 0 - 24 h postoperatively

Total rescue morphine consumption during 0 - 24 h would be the primary endpoint

次要结局

  • Postoperative pain(4 h postoperatively)
  • Plasma concentration of lidocaine(24 h)
  • Length of Hospital stay(1-5 days)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anil Gupta

Associate Professor

Örebro University, Sweden

研究点 (1)

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