Effect of Oral Choline Supplementation on Postoperative Pain

NCT ID: NCT00720343

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-12-31

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.

Conditions

Postoperative Pain; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Choline

Oral choline

Group Type: EXPERIMENTAL

Choline

Intervention Type: DRUG

Oral Choline 20 grams before surgery

Placebo

Gelatin Capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Gelatin Capsule

Interventions

Choline

Oral Choline 20 grams before surgery

Intervention Type: DRUG

Placebo

Gelatin Capsule

Intervention Type: DRUG

Other Intervention Names

Tricholine 1200; Gelatin Capsule

Eligibility Criteria

Inclusion Criteria

• open pelvic surgery
• able to swallow pills

Exclusion Criteria

• chronic pain
• opioid use
• pregnancy
• lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Flood, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

New York Presbyterian Hospital

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23568851 (View on PubMed)

Other Identifiers

1R21AT004708-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAC8413

Identifier Type: -

Identifier Source: org_study_id