Gynecological Surgery, Acupuncture, Post-operative Pain
Conditions
Keywords
surgery, acupuncture, gynecology, pain, narcotics
Brief summary
This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.
Detailed description
The goal of the study is to investigate acupuncture at the time of gynecological surgery as a way to decrease post-operative pain which would decrease narcotic intake and hospitalization time. To do this, the researchers will recruit non-pregnant patients over the age of 18 who are undergoing laparoscopic surgery for a benign gynecological indication. These patients will be randomized using a computer generated randomization system to receive either acupuncture or sham acupuncture pre-operatively after the induction of anesthesia. The acupuncture points used will be points proven in the literature to be associated with decreasing general pain, pelvic pain and nausea and vomiting. The needles will be placed by a anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while the patient is prepped for the surgery. The sham points will be on the hands and feet and chosen at random by the gynecologic surgeon who is not trained in acupuncture. For both groups, the acupuncture needles will be removed before the first incision of the surgery. All patients will be blinded to their group allocation.
Interventions
DEVICEAcupuncture needles
Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* female patients * over the age of 18 * scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa
Exclusion criteria
* male patients * pregnancy * suspected or known malignant disease * immunocompromised * known or persistent abuse of medications, drugs or alcohol * chronic pain for greater than 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalent Usage While in the Hospital | Intra-operative and 24 hours post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pain Medication Tablets Used at Home Post-Operatively | 7 days post-operatively | Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively. |
| Number of Patients Readmitted to the Hospital | 2 weeks post-operatively | Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management. |
| Pain Score | up to 4 hours post operatively | Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain |
| Pain Score at Home Post-Operatively | up to 7 days post operatively | Pain Score from 0-10 with higher score indicating more pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| 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. | 56 |
| Total | 110 |
Baseline characteristics
| Characteristic | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Age, Continuous | 43.99 years STANDARD_DEVIATION 10.84 | 48.58 years STANDARD_DEVIATION 12.52 | 45 years STANDARD_DEVIATION 11.13 |
| Body Mass Index (BMI) | 27.17 kg/m^2 STANDARD_DEVIATION 6.95 | 27.34 kg/m^2 STANDARD_DEVIATION 6.64 | 27.22 kg/m^2 STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 45 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 6 Participants | 17 Participants |
| Indication for surgery Abnormal Uterine Bleeding (AUB) | 30 Participants | 30 Participants | 60 Participants |
| Indication for surgery Adnexal mass | 2 Participants | 5 Participants | 7 Participants |
| Indication for surgery Bulk | 8 Participants | 6 Participants | 14 Participants |
| Indication for surgery Infertility | 5 Participants | 2 Participants | 7 Participants |
| Indication for surgery Other | 2 Participants | 1 Participants | 3 Participants |
| Indication for surgery Prolapse | 7 Participants | 12 Participants | 19 Participants |
| Prior abdominal surgery | 21 Participants | 29 Participants | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 14 Participants | 36 Participants |
| Race (NIH/OMB) White | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Female | 54 Participants | 56 Participants | 110 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 / 54 | 0 / 56 |
| other Total, other adverse events | 0 / 54 | 0 / 56 |
| serious Total, serious adverse events | 0 / 54 | 0 / 56 |
Outcome results
Primary
Morphine Equivalent Usage While in the Hospital
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.
Time frame: Intra-operative and 24 hours post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Morphine Equivalent Usage While in the Hospital | 24 hours Post-operative | 10.54 mg | Standard Deviation 8.33 |
| Acupuncture | Morphine Equivalent Usage While in the Hospital | Intra-operative | 29.59 mg | Standard Deviation 14.42 |
| Sham Acupuncture | Morphine Equivalent Usage While in the Hospital | Intra-operative | 30.82 mg | Standard Deviation 12.47 |
| Sham Acupuncture | Morphine Equivalent Usage While in the Hospital | 24 hours Post-operative | 11.74 mg | Standard Deviation 10.36 |
Secondary
Number of Pain Medication Tablets Used at Home Post-Operatively
Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.
Time frame: 7 days post-operatively
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Acupuncture | Number of Pain Medication Tablets Used at Home Post-Operatively | oxycodone/acetaminophen tablets | 6 tablets |
| Acupuncture | Number of Pain Medication Tablets Used at Home Post-Operatively | ibuprofen tablets | 5 tablets |
| Sham Acupuncture | Number of Pain Medication Tablets Used at Home Post-Operatively | oxycodone/acetaminophen tablets | 4 tablets |
| Sham Acupuncture | Number of Pain Medication Tablets Used at Home Post-Operatively | ibuprofen tablets | 6.5 tablets |
Secondary
Number of Patients Readmitted to the Hospital
Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.
Time frame: 2 weeks post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acupuncture | Number of Patients Readmitted to the Hospital | 0 Participants |
| Sham Acupuncture | Number of Patients Readmitted to the Hospital | 0 Participants |
Secondary
Pain Score
Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain
Time frame: up to 4 hours post operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | Pain Score | Hour 0 | 2.95 score on a scale |
| Acupuncture | Pain Score | Hour 1 | 4.27 score on a scale |
| Acupuncture | Pain Score | Hour 2 | 3.49 score on a scale |
| Acupuncture | Pain Score | Hour 4 | 3.10 score on a scale |
| Sham Acupuncture | Pain Score | Hour 4 | 3.00 score on a scale |
| Sham Acupuncture | Pain Score | Hour 0 | 4.05 score on a scale |
| Sham Acupuncture | Pain Score | Hour 2 | 3.61 score on a scale |
| Sham Acupuncture | Pain Score | Hour 1 | 4.50 score on a scale |
Secondary
Pain Score at Home Post-Operatively
Pain Score from 0-10 with higher score indicating more pain
Time frame: up to 7 days post operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acupuncture | Pain Score at Home Post-Operatively | Day 7 | 1.93 score on a scale |
| Acupuncture | Pain Score at Home Post-Operatively | Day 1 | 4.62 score on a scale |
| Acupuncture | Pain Score at Home Post-Operatively | Day 2 | 4.18 score on a scale |
| Acupuncture | Pain Score at Home Post-Operatively | Day 3 | 3.60 score on a scale |
| Acupuncture | Pain Score at Home Post-Operatively | Day 4 | 3.03 score on a scale |
| Acupuncture | Pain Score at Home Post-Operatively | Day 5 | 2.61 score on a scale |
| Acupuncture | Pain Score at Home Post-Operatively | Day 6 | 2.21 score on a scale |
| Sham Acupuncture | Pain Score at Home Post-Operatively | Day 7 | 1.76 score on a scale |
| Sham Acupuncture | Pain Score at Home Post-Operatively | Day 4 | 3.00 score on a scale |
| Sham Acupuncture | Pain Score at Home Post-Operatively | Day 1 | 5.27 score on a scale |
| Sham Acupuncture | Pain Score at Home Post-Operatively | Day 6 | 2.06 score on a scale |
| Sham Acupuncture | Pain Score at Home Post-Operatively | Day 2 | 4.40 score on a scale |
| Sham Acupuncture | Pain Score at Home Post-Operatively | Day 5 | 2.38 score on a scale |
| Sham Acupuncture | Pain Score at Home Post-Operatively | Day 3 | 3.73 score on a scale |