Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
- Conditions
- Post-operative PainGynecological SurgeryAcupuncture
- Interventions
- Device: Acupuncture needles
- Registration Number
- NCT02855567
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
- female patients
- over the age of 18
- scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham acupuncture Acupuncture needles 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. Acupuncture Acupuncture needles 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States