Effect of Oral Choline Supplementation on Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Effect of Oral Choline Supplementation on Postoperative Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00720343
• Other study ID #: AAAC8413
• Secondary ID: 1R21AT004708-01A
• Status: Terminated
• Phase: Phase 4
• First received: July 21, 2008
• Last updated: March 23, 2016
• Start date: February 2009
• Est. completion date: June 2011

Study information

• Verified date: March 2016
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• open pelvic surgery

• able to swallow pills

Exclusion Criteria:

• chronic pain

• opioid use

• pregnancy

• lactation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Choline
Oral Choline 20 grams before surgery
• Placebo
Gelatin Capsule

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Pain		24 hours after surgery	No
Secondary	Prevalence of Nausea		24 hours after surgery	Yes
Secondary	Prevalence of High Blood Choline Concentration		24 hours after surgery	No
Secondary	Prevalence of Opioid Use		24 hours after surgery	No