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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AT004708-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This research will test whether consuming additional choline before gynecological surgery decreases postoperative pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline | Experimental | Oral choline |
|
| Placebo | Placebo Comparator | Gelatin Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline | Drug | Oral Choline 20 grams before surgery |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Score | NRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable | End of surgery, and 1 hour after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Morphine Used by Participants Post-surgery | 1 hour after surgery, and 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Flood, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23568851 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Choline | Participants ingested ten tablets (GNC Triple Lecithin 1200 choline tablets) containing 12 g of high choline lecithin and 4.2 g phosphatidyl choline the night before surgery. On the day of surgery, a second dose of study drug (equivalent to ten tablets) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia. |
| FG001 | Placebo | Participants ingested ten gelatin capsules the night before surgery. On the day of surgery, a second dose of the placebo (equivalent to ten capsules) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Choline | Participants ingested ten tablets (GNC Triple Lecithin 1200 choline tablets) containing 12 g of high choline lecithin and 4.2 g phosphatidyl choline the night before surgery. On the day of surgery, a second dose of study drug (equivalent to ten tablets) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numerical Rating Scale (NRS) Pain Score | NRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable | Posted | Mean | Standard Deviation | score on a scale | End of surgery, and 1 hour after surgery |
|
Up to 24 hours post-surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Choline | Participants ingested ten tablets (GNC Triple Lecithin 1200 choline tablets) containing 12 g of high choline lecithin and 4.2 g phosphatidyl choline the night before surgery. On the day of surgery, a second dose of study drug (equivalent to ten tablets) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Flood, M.D. | Stanford University | 201-370-3933 | pflood@stanford.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002794 | Choline |
| D005780 | Gelatin |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Gelatin Capsule |
|
|
| BG001 | Placebo | Participants ingested ten gelatin capsules the night before surgery. On the day of surgery, a second dose of the placebo (equivalent to ten capsules) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Amount of Morphine Used by Participants Post-surgery | Posted | Mean | 95% Confidence Interval | mg | 1 hour after surgery, and 24 hours after surgery |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Placebo | Participants ingested ten gelatin capsules the night before surgery. On the day of surgery, a second dose of the placebo (equivalent to ten capsules) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |
| D012596 | Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |