Effect of Oral Choline Supplementation on Postoperative Pain

• Sponsor: Columbia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00720343
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 27.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Inflammation	Drug: Choline; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Oral Choline Supplementation on Postoperative Pain
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Choline Oral choline	Drug: Choline; Oral Choline 20 grams before surgery; Other Names: Tricholine 1200
Placebo Comparator: Placebo Gelatin Capsule	Drug: Placebo; Gelatin Capsule; Other Names: Gelatin Capsule

Outcome Measures

Primary Outcome Measures

1. Prevalence of Pain [24 hours after surgery]

Secondary Outcome Measures

1. Prevalence of Nausea [24 hours after surgery]

2. Prevalence of High Blood Choline Concentration [24 hours after surgery]

3. Prevalence of Opioid Use [24 hours after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• open pelvic surgery

• able to swallow pills

Exclusion Criteria:

• chronic pain

• opioid use

• pregnancy

• lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian Hospital	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Pamela Flood, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT00720343
• Other Study ID Numbers: AAAC8413; 1R21AT004708-01A1
• First Posted: Jul 22, 2008
• Last Update Posted: Mar 25, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Inflammation; Pain, Postoperative; Choline

Study Results

Participant Flow

Recruitment Details	The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.

Arm/Group Title	Choline or Placebo
Arm/Group Description	Oral choline or Placebo Choline: Oral Choline or Placebo 20 grams before surgery
Period Title: Overall Study
STARTED	54
COMPLETED	48
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Choline or Placebo
Arm/Group Description	Oral choline or Placebo Choline: Oral Choline or Placebo 20 grams before surgery
Overall Participants	54
Age, Customized (participants) [Number]
18 to 60 years	54 100%
Sex: Female, Male (Count of Participants)
Female	54 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	54 100%

Outcome Measures

1. Primary Outcome

Title	Prevalence of Pain
Time Frame	24 hours after surgery

Outcome Measure Data

Analysis Population Description

The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.

Arm/Group Title	Choline	Placebo
Arm/Group Description	Oral choline Choline: Oral Choline 20 grams before surgery	Gelatin Capsule Placebo: Gelatin Capsule
Measure Participants	0	0

2. Secondary Outcome

Title	Prevalence of Nausea
Time Frame	24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Prevalence of High Blood Choline Concentration
Time Frame	24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Prevalence of Opioid Use
Time Frame	24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to the IRB in February 2011.
Arm/Group Title	Choline		Placebo
Arm/Group Description	Oral choline Choline: Oral Choline 20 grams before surgery		Gelatin Capsule Placebo: Gelatin Capsule
All Cause Mortality
	Choline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Choline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Choline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.