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Clinical Trials/NCT00720343
NCT00720343
Completed
Phase 4

Effect of Oral Choline Supplementation on Postoperative Pain

Columbia University1 site in 1 country60 target enrollmentFebruary 2009

Overview

Phase
Phase 4
Intervention
Choline
Conditions
Postoperative Pain
Sponsor
Columbia University
Enrollment
60
Locations
1
Primary Endpoint
Numerical Rating Scale (NRS) Pain Score
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
December 2012
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • open pelvic surgery
  • able to swallow pills

Exclusion Criteria

  • chronic pain
  • opioid use
  • pregnancy
  • lactation

Arms & Interventions

Choline

Oral choline

Intervention: Choline

Placebo

Gelatin Capsule

Intervention: Placebo

Outcomes

Primary Outcomes

Numerical Rating Scale (NRS) Pain Score

Time Frame: End of surgery, and 1 hour after surgery

NRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable

Secondary Outcomes

  • Amount of Morphine Used by Participants Post-surgery(1 hour after surgery, and 24 hours after surgery)

Study Sites (1)

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