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临床试验/NCT00720343
NCT00720343已完成4 期

Effect of Oral Choline Supplementation on Postoperative Pain

Columbia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年2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
入组人数
60
试验地点
1
主要终点
Numerical Rating Scale (NRS) Pain Score

研究概览

简要总结

This research will test whether consuming additional choline before gynecological surgery decreases postoperative pain.

详细描述

More than 70% of the patients undergoing surgery in the USA, experience moderate to severe pain after the surgery in spite of being treated for pain. We will test whether choline will produce an effective additional analgesic action for postoperative pain treatment. Choline and lecithin are safe and are available for consumers as over-the-counter nutritional supplements. Choline supplementation decreases postoperative pain in rodents. Also Nicotine decreases postoperative pain in humans and since choline acts on the same receptors as nicotine, choline supplementation may be effective as an analgesic without the risks of addiction and the side effects like high heart rate and blood pressure.

Sixty women between the ages 18 and 60 undergoing open abdominal gynecological surgeries will be studied. We will not study people with chronic pain, drug abuse, and/or nicotine use over the past six months, current pregnancy or breastfeeding, allergy to soy, or inability to take any drug that we will use in the study.

Patients will take 10 tablets (choline or gelatin powder placebo) the night before surgery. After anesthesia, a second dose will be given into a tube that goes into the patient's stomach. One tablespoon of blood (15 mL) will be drawn five times to measure genetics, changes in levels of plasma choline and inflammatory markers: blood will be drawn at the preoperative visit, three times on the day of surgery and once 24 hours postoperatively. At 24 hours after surgery and on their follow-up visit with their doctor, the patient's surgical wound will be photographed and patients will complete a survey on satisfaction with treatment.

Primarily we are looking at the pain scores after surgery and secondarily at the pain medication use, plasma choline levels, wound healing and satisfaction with pain treatment.

This is a randomized double blind study. Patients will consume ten tablets (10g choline or placebo) the night before undergoing gynecological surgery and 10 tablets the morning of surgery. We will measure pain after surgery, baseline and postoperative plasma choline, and test genetics.

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • open pelvic surgery
  • able to swallow pills

排除标准

  • chronic pain
  • opioid use
  • pregnancy
  • lactation

研究组 & 干预措施

Choline

Experimental

Oral choline

干预措施: Choline (Drug)

Placebo

Placebo Comparator

Gelatin Capsule

干预措施: Placebo (Drug)

结局指标

主要结局

Numerical Rating Scale (NRS) Pain Score

时间窗: End of surgery, and 1 hour after surgery

NRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable

次要结局

  • Amount of Morphine Used by Participants Post-surgery(1 hour after surgery, and 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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