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Completed

NCT Number: NCT00720343

Effect of Oral Choline Supplementation on Postoperative Pain

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

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

New York Presbyterian Hospital

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • open pelvic surgery
  • able to swallow pills

Exclusion criteria

  • chronic pain
  • opioid use
  • pregnancy
  • lactation

Treatment and study plan

Choline

Drug

Oral Choline 20 grams before surgery

Other names: Tricholine 1200

Placebo

Drug

Gelatin Capsule

Other names: Gelatin Capsule

Primary outcomes

  1. Numerical Rating Scale (NRS) Pain Score

    Time frame: 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

Secondary outcomes

  1. Amount of Morphine Used by Participants Post-surgery

    Time frame: 1 hour after surgery, and 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 22, 2008
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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