Effect of Oral Choline Supplementation on Postoperative Pain
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Oral Choline Supplementation on Postoperative Pain|
- Prevalence of Pain [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
- Prevalence of Nausea [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: Yes ]
- Prevalence of High Blood Choline Concentration [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
- Prevalence of Opioid Use [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Oral Choline 20 grams before surgery
Other Name: Tricholine 1200
Placebo Comparator: Placebo
Other Name: Gelatin Capsule
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720343
|United States, New York|
|New York Presbyterian Hospital|
|New York, New York, United States, 10032|
|Principal Investigator:||Pamela Flood, MD||Columbia University|