Effect of Oral Choline Supplementation on Postoperative Pain

This study has been terminated.
(Investigator left the institution)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00720343
First received: July 21, 2008
Last updated: February 6, 2013
Last verified: February 2013

July 21, 2008
February 6, 2013
February 2009
June 2011   (final data collection date for primary outcome measure)
Pain [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00720343 on ClinicalTrials.gov Archive Site
  • Nausea [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: Yes ]
  • Blood Choline Concentration [ Time Frame: 24 hours after surgury ] [ Designated as safety issue: No ]
  • Opioid Use [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
Same as current
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
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
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00720343
AAAC8413, 1R21AT004708-01A1
Yes
Columbia University
Columbia University
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Pamela Flood, MD Columbia University
Columbia University
February 2013

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