Trial Outcomes & Findings for Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery (NCT NCT02855567)
NCT ID: NCT02855567
Last Updated: 2019-06-25
Results Overview
Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively. Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Intra-operative and 24 hours post-operatively
Results posted on
2019-06-25
Participant Flow
Participant milestones
| Measure |
Acupuncture
Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
|
Sham Acupuncture
Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
56
|
|
Overall Study
COMPLETED
|
54
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
Baseline characteristics by cohort
| Measure |
Acupuncture
n=54 Participants
Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
|
Sham Acupuncture
n=56 Participants
Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.99 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
48.58 years
STANDARD_DEVIATION 12.52 • n=7 Participants
|
45 years
STANDARD_DEVIATION 11.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.17 kg/m^2
STANDARD_DEVIATION 6.95 • n=5 Participants
|
27.34 kg/m^2
STANDARD_DEVIATION 6.64 • n=7 Participants
|
27.22 kg/m^2
STANDARD_DEVIATION 6.70 • n=5 Participants
|
|
Prior abdominal surgery
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Indication for surgery
Abnormal Uterine Bleeding (AUB)
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Indication for surgery
Adnexal mass
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Indication for surgery
Bulk
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Indication for surgery
Infertility
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Indication for surgery
Prolapse
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Indication for surgery
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intra-operative and 24 hours post-operativelyEffectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively. Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.
Outcome measures
| Measure |
Acupuncture
n=54 Participants
Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
|
Sham Acupuncture
n=56 Participants
Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
|
|---|---|---|
|
Morphine Equivalent Usage While in the Hospital
Intra-operative
|
29.59 mg
Standard Deviation 14.42
|
30.82 mg
Standard Deviation 12.47
|
|
Morphine Equivalent Usage While in the Hospital
24 hours Post-operative
|
10.54 mg
Standard Deviation 8.33
|
11.74 mg
Standard Deviation 10.36
|
SECONDARY outcome
Timeframe: 7 days post-operativelyPatients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.
Outcome measures
| Measure |
Acupuncture
n=54 Participants
Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
|
Sham Acupuncture
n=56 Participants
Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
|
|---|---|---|
|
Number of Pain Medication Tablets Used at Home Post-Operatively
oxycodone/acetaminophen tablets
|
6 tablets
Interval 1.5 to 8.0
|
4 tablets
Interval 0.0 to 9.0
|
|
Number of Pain Medication Tablets Used at Home Post-Operatively
ibuprofen tablets
|
5 tablets
Interval 0.0 to 15.5
|
6.5 tablets
Interval 0.0 to 13.5
|
SECONDARY outcome
Timeframe: 2 weeks post-operativelyEffectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.
Outcome measures
| Measure |
Acupuncture
n=54 Participants
Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
|
Sham Acupuncture
n=56 Participants
Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
|
|---|---|---|
|
Number of Patients Readmitted to the Hospital
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 4 hours post operativelyPain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain
Outcome measures
| Measure |
Acupuncture
n=54 Participants
Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
|
Sham Acupuncture
n=56 Participants
Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
|
|---|---|---|
|
Pain Score
Hour 0
|
2.95 score on a scale
Interval 2.04 to 3.85
|
4.05 score on a scale
Interval 3.19 to 4.9
|
|
Pain Score
Hour 1
|
4.27 score on a scale
Interval 3.48 to 5.06
|
4.50 score on a scale
Interval 3.67 to 5.33
|
|
Pain Score
Hour 2
|
3.49 score on a scale
Interval 2.69 to 4.29
|
3.61 score on a scale
Interval 2.8 to 4.42
|
|
Pain Score
Hour 4
|
3.10 score on a scale
Interval 2.09 to 4.12
|
3.00 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: up to 7 days post operativelyPain Score from 0-10 with higher score indicating more pain
Outcome measures
| Measure |
Acupuncture
n=54 Participants
Received acupuncture during gynecological surgery at 5 known points for pain control. Needles placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient was prepped for surgery. 30-gauge needles were placed for 15 minutes while the patient was positioned and prepped for surgery.
|
Sham Acupuncture
n=56 Participants
Received acupuncture during gynecological surgery at sham points not associated with pain control. The same size needles were placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery. The needles were removed immediately after placement.
|
|---|---|---|
|
Pain Score at Home Post-Operatively
Day 1
|
4.62 score on a scale
Interval 3.97 to 5.28
|
5.27 score on a scale
Interval 4.65 to 5.88
|
|
Pain Score at Home Post-Operatively
Day 2
|
4.18 score on a scale
Interval 3.53 to 4.84
|
4.40 score on a scale
Interval 3.78 to 5.02
|
|
Pain Score at Home Post-Operatively
Day 3
|
3.60 score on a scale
Interval 2.94 to 4.25
|
3.73 score on a scale
Interval 3.11 to 4.35
|
|
Pain Score at Home Post-Operatively
Day 4
|
3.03 score on a scale
Interval 2.36 to 3.69
|
3.00 score on a scale
Interval 2.37 to 3.63
|
|
Pain Score at Home Post-Operatively
Day 5
|
2.61 score on a scale
Interval 1.95 to 3.28
|
2.38 score on a scale
Interval 1.75 to 3.0
|
|
Pain Score at Home Post-Operatively
Day 6
|
2.21 score on a scale
Interval 1.55 to 2.88
|
2.06 score on a scale
Interval 1.43 to 2.68
|
|
Pain Score at Home Post-Operatively
Day 7
|
1.93 score on a scale
Interval 1.26 to 2.59
|
1.76 score on a scale
Interval 1.13 to 2.38
|
Adverse Events
Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Charles Ascher-Walsh
Icahn School of Medicine at Mount Sinai
Phone: 212-241-2827
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place