Postoperative Pain, Inflammation
Conditions
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.
Interventions
DRUGCholine
Oral Choline 20 grams before surgery
DRUGPlacebo
Gelatin Capsule
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* open pelvic surgery * able to swallow pills
Exclusion criteria
* chronic pain * opioid use * pregnancy * lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Score | End of surgery, and 1 hour after surgery | NRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable |
Secondary
| Measure | Time frame |
|---|---|
| Amount of Morphine Used by Participants Post-surgery | 1 hour after surgery, and 24 hours after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 28 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | Choline | Placebo | Total |
|---|---|---|---|
| Age, Customized 18-21 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 22-59 years | 29 Participants | 28 Participants | 57 Participants |
| Age, Customized >60 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 10 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 17 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 18 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 6 Participants | 8 Participants | 14 Participants |
| Region of Enrollment United States | 29 participants | 28 participants | 57 participants |
| Sex: Female, Male Female | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 0 / 29 | 0 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
Primary
Numerical Rating Scale (NRS) Pain Score
NRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable
Time frame: End of surgery, and 1 hour after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Choline | Numerical Rating Scale (NRS) Pain Score | End of surgery | 5.8 score on a scale | Standard Deviation 2.2 |
| Choline | Numerical Rating Scale (NRS) Pain Score | 1 hour after surgery | 7.4 score on a scale | Standard Deviation 5.2 |
| Placebo | Numerical Rating Scale (NRS) Pain Score | End of surgery | 7.4 score on a scale | Standard Deviation 1.7 |
| Placebo | Numerical Rating Scale (NRS) Pain Score | 1 hour after surgery | 8.8 score on a scale | Standard Deviation 3.2 |
Secondary
Amount of Morphine Used by Participants Post-surgery
Time frame: 1 hour after surgery, and 24 hours after surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Choline | Amount of Morphine Used by Participants Post-surgery | 1 hour after surgery | 3.6 mg |
| Choline | Amount of Morphine Used by Participants Post-surgery | 24 hours after surgery | 49 mg |
| Placebo | Amount of Morphine Used by Participants Post-surgery | 1 hour after surgery | 4 mg |
| Placebo | Amount of Morphine Used by Participants Post-surgery | 24 hours after surgery | 48 mg |