Effect of Oral Choline Supplementation on Postoperative Pain
| Status: | Terminated |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | February 2009 |
| End Date: | June 2011 |
This research will test whether consuming additional choline before gynecological surgery
decreases postoperative pain.
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.
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.
Inclusion Criteria:
- open pelvic surgery
- able to swallow pills
Exclusion Criteria:
- chronic pain
- opioid use
- pregnancy
- lactation
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