The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-operative Pain
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Morphine Equivalent Usage While in the Hospital
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Morphine Equivalent Usage While in the Hospital
Time Frame: 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 Outcomes
- Number of Pain Medication Tablets Used at Home Post-Operatively(7 days post-operatively)
- Number of Patients Readmitted to the Hospital(2 weeks post-operatively)
- Pain Score(up to 4 hours post operatively)
- Pain Score at Home Post-Operatively(up to 7 days post operatively)