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This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Active Comparator | Receives acupuncture during gynecological surgery at 5 known points for pain control. Needles will be placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient is prepped for surgery. They will be in place for 15 minutes. |
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| Sham acupuncture | Sham Comparator | Receives acupuncture during gynecological surgery at sham points not associated with pain control. Needles will be 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 will be removed immediately after placement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture needles | Device | Acupuncture needles (29 and 30 gauge) used to perform the acupuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-operative and 24 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days post-operatively |
| Number of Patients Readmitted to the Hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Ascher-Walsh, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Mean | Standard Deviation | mg | Intra-operative and 24 hours post-operatively |
|
7 days
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Ascher-Walsh | Icahn School of Medicine at Mount Sinai | 212-241-2827 | Charles.ascher-walsh@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2016 | May 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management. |
| 2 weeks post-operatively |
| Pain Score | Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain | up to 4 hours post operatively |
| Pain Score at Home Post-Operatively | Pain Score from 0-10 with higher score indicating more pain | up to 7 days post operatively |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Prior abdominal surgery | Count of Participants | Participants |
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| Indication for surgery | Count of Participants | Participants |
|
| 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. |
|
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| 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. | Posted | Median | Inter-Quartile Range | tablets | 7 days post-operatively |
|
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| 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. | Posted | Count of Participants | Participants | 2 weeks post-operatively |
|
|
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| Secondary | Pain Score | Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain | Posted | Mean | 95% Confidence Interval | score on a scale | up to 4 hours post operatively |
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| Secondary | Pain Score at Home Post-Operatively | Pain Score from 0-10 with higher score indicating more pain | Posted | Mean | 95% Confidence Interval | score on a scale | up to 7 days post operatively |
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|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | 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. | 0 | 56 | 0 | 56 | 0 | 56 |
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| D012816 | Signs and Symptoms |
| Hour 2 |
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| Hour 4 |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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