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Effect of Oral Choline Supplementation on Postoperative Pain

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ClinicalTrials.gov 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

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Inflammation Drug: Choline Drug: Placebo Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Oral Choline Supplementation on Postoperative Pain
Study Start Date : February 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Choline
Oral choline
Drug: Choline
Oral Choline 20 grams before surgery
Other Name: Tricholine 1200
Placebo Comparator: Placebo
Gelatin Capsule
Drug: Placebo
Gelatin Capsule
Other Name: Gelatin Capsule

Primary Outcome Measures :
  1. Prevalence of Pain [ Time Frame: 24 hours after surgery ]

Secondary Outcome Measures :
  1. Prevalence of Nausea [ Time Frame: 24 hours after surgery ]
  2. Prevalence of High Blood Choline Concentration [ Time Frame: 24 hours after surgery ]
  3. Prevalence of Opioid Use [ Time Frame: 24 hours after surgery ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • open pelvic surgery
  • able to swallow pills

Exclusion Criteria:

  • chronic pain
  • opioid use
  • pregnancy
  • lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720343

United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Pamela Flood, MD Columbia University

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00720343     History of Changes
Other Study ID Numbers: AAAC8413
1R21AT004708-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2008    Key Record Dates
Results First Posted: March 25, 2016
Last Update Posted: March 25, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Pain, Postoperative
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Signs and Symptoms
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents