Effect of Oral Choline Supplementation on Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00720343
Recruitment Status : Terminated (PI left the institution.)
First Posted : July 22, 2008
Results First Posted : March 25, 2016
Last Update Posted : March 25, 2016
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Columbia University

July 21, 2008
July 22, 2008
March 23, 2016
March 25, 2016
March 25, 2016
February 2009
June 2011   (Final data collection date for primary outcome measure)
Prevalence of Pain [ Time Frame: 24 hours after surgery ]
Pain [ Time Frame: 24 hours after surgery ]
Complete list of historical versions of study NCT00720343 on Archive Site
  • Prevalence of Nausea [ Time Frame: 24 hours after surgery ]
  • Prevalence of High Blood Choline Concentration [ Time Frame: 24 hours after surgery ]
  • Prevalence of Opioid Use [ Time Frame: 24 hours after surgery ]
  • Nausea [ Time Frame: 24 hours after surgery ]
  • Blood Choline Concentration [ Time Frame: 24 hours after surgury ]
  • Opioid Use [ Time Frame: 24 hours after surgery ]
Not Provided
Not Provided
Effect of Oral Choline Supplementation on Postoperative Pain
Effect of Oral Choline Supplementation on Postoperative Pain
This research will test whether consuming additional choline before gynecological surgery decreases postoperative pain.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative Pain
  • Inflammation
  • Drug: Choline
    Oral Choline 20 grams before surgery
    Other Name: Tricholine 1200
  • Drug: Placebo
    Gelatin Capsule
    Other Name: Gelatin Capsule
  • Experimental: Choline
    Oral choline
    Intervention: Drug: Choline
  • Placebo Comparator: Placebo
    Gelatin Capsule
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • open pelvic surgery
  • able to swallow pills

Exclusion Criteria:

  • chronic pain
  • opioid use
  • pregnancy
  • lactation
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1R21AT004708-01A1 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Columbia University
Columbia University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Pamela Flood, MD Columbia University
Columbia University
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP