Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery

Study Overview
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Brief Summary
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This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.

Detailed Description
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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.

Official Title
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The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients

Conditions
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Post-operative Pain, Gynecological Surgery, Acupuncture

Intervention / Treatment
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* Device: Acupuncture needles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture<br>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. | Device: Acupuncture needles<br>* Acupuncture needles (29 and 30 gauge) used to perform the acupuncture<br>|
| Sham Comparator: Sham acupuncture<br>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. | Device: Acupuncture needles<br>* Acupuncture needles (29 and 30 gauge) used to perform the acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, acupuncture, gynecology, pain, narcotics