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临床试验/NCT01492075
NCT01492075已完成4 期

Phase IV Study of Postoperative Pain Management

Örebro University, Sweden1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年1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
40
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

The investigators hypothesis is that patient controlled local anesthetics administered intraabdominally are more efficacious compared to continuous infusion in reducing postoperative pain and morphine consumption.

详细描述

Open abdominal hysterectomy is a common procedure performed for many benign and malignant gynaecological diseases and is associated with moderate to severe pain. Traditional methods for postoperative pain management include patient controlled intravenous analgesia (PCA) using morphine, epidural analgesia and spinal analgesia with opiates but recently, even local aesthetic (LA) has been used intra-abdominally and into the abdominal wall. Although epidural analgesia may be considered by some to be gold standard for pain relief following abdominal surgery, a recent publication and past experience over several years may question the use of invasive techniques for lower abdominal surgery. Thus, there is a trend towards movement from central blocks towards other non-invasive methods for pain relief.

PCA with morphine is now commonly used for management of pain following major surgery and compared to central blocks, has advantages in being relatively safe, easy to use and associated with a high degree of patient satisfaction. However, the large doses of morphine necessary to ensure adequate postoperative analgesia means that side effects such as postoperative nausea and vomiting (PONV), tiredness, pruritus, headache and constipation may be a major problem in this group of patients. Therefore, alternative techniques to reduce morphine requirements are increasingly being used. These include the use of paracetamol, non-steroidal anti-inflammatory drugs (NSAID) and recently local anaesthetics (LA). The latter have been found to result in morphine sparing by 30 - 40 % and even a reduction in postoperative nausea (PON). LA infused intraperitoneally is safe and effective and a recent study showed that using 12.5 mg/h levobupivacaine could attain adequate analgesia. Thus, efficacy of LA has been established as well as the dose. However, the method of administration of LA intraperitoneally remains unclear.

This study is designed with the primary aim of studying whether morphine consumption can be reduced postoperatively using the patient-controlled administration system for intraperitoneal LA compared to a continuous infusion, and whether this translates into improved recovery parameters or reduced side effects and improved patient satisfaction.

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

  • 18 -65 year old patients undergoing open abdominal hysterectomy.
  • ASA I - II (Appendix 1).
  • Have signed and dated Informed Consent.
  • Willing and able to comply with the protocol for the duration of the trial.

排除标准

  • Patients undergoing open abdominal hysterectomy due to suspected cancer.
  • Patients with chronic pain who are taking analgesics regularly.
  • Allergy to components in levobupivacaine (Chirocaine)/Saline (Sodium Chloride).
  • Participation in other clinical trials.

研究组 & 干预措施

Continuous infusion

Active Comparator

Continuous infusion of LA intraabdominally

干预措施: PCRA (Intermittent injection) (Drug)

PCRA (Intermittent injection)

Experimental

Patient controlled LA intraabdominally

干预措施: PCRA (Intermittent injection) (Drug)

结局指标

主要结局

Morphine consumption

时间窗: 0-24 h

Total morphine consumption 0 - 24 h postoperatively

次要结局

  • Home discharge(0-10 days)
  • Postoperative pain(0 - 48 h postoperatively)
  • PONV(0 - 48 h postoperatively)

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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