Clinical trial NCT00720343: Effect of Oral Choline Supplementation on Postoperative Pain
Official title: Effect of Oral Choline Supplementation on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Inflammation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-07-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* open pelvic surgery
* able to swallow pills

Exclusion Criteria:

* chronic pain
* opioid use
* pregnancy
* lactation

Primary outcomes:
measure: Numerical Rating Scale (NRS) Pain Score
timeFrame: End of surgery, and 1 hour after surgery
Secondary outcomes:
measure: Amount of Morphine Used by Participants Post-surgery
timeFrame: 1 hour after surgery, and 24 hours after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Stanford University
name: Pamela Flood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sidhu N, Davies S, Nadarajah A, Rivera J, Whittington R, Mercier RJ, Virag L, Wang S, Flood P. Oral choline supplementation for postoperative pain. Br J Anaesth. 2013 Aug;111(2):249-55. doi: 10.1093/bja/aet031. Epub 2013 Apr 7.