Effect of Oral Choline Supplementation on Postoperative Pain
Primary Purpose
Postoperative Pain, Inflammation
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Choline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- open pelvic surgery
- able to swallow pills
Exclusion Criteria:
- chronic pain
- opioid use
- pregnancy
- lactation
Sites / Locations
- New York Presbyterian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Choline
Placebo
Arm Description
Oral choline
Gelatin Capsule
Outcomes
Primary Outcome Measures
Prevalence of Pain
Secondary Outcome Measures
Prevalence of Nausea
Prevalence of High Blood Choline Concentration
Prevalence of Opioid Use
Full Information
NCT ID
NCT00720343
First Posted
July 21, 2008
Last Updated
March 23, 2016
Sponsor
Columbia University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00720343
Brief Title
Effect of Oral Choline Supplementation on Postoperative Pain
Official Title
Effect of Oral Choline Supplementation on Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
PI left the institution.
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Choline
Arm Type
Experimental
Arm Description
Oral choline
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Gelatin Capsule
Intervention Type
Drug
Intervention Name(s)
Choline
Other Intervention Name(s)
Tricholine 1200
Intervention Description
Oral Choline 20 grams before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Gelatin Capsule
Intervention Description
Gelatin Capsule
Primary Outcome Measure Information:
Title
Prevalence of Pain
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Prevalence of Nausea
Time Frame
24 hours after surgery
Title
Prevalence of High Blood Choline Concentration
Time Frame
24 hours after surgery
Title
Prevalence of Opioid Use
Time Frame
24 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
open pelvic surgery
able to swallow pills
Exclusion Criteria:
chronic pain
opioid use
pregnancy
lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Flood, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Oral Choline Supplementation on Postoperative Pain
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