Clinical trial NCT02855567: Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
Official title: The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Gynecological Surgery
Acupuncture
Keywords: surgery
acupuncture
gynecology
pain
narcotics
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morphine Equivalent Usage While in the Hospital
timeFrame: Intra-operative and 24 hours post-operatively
Secondary outcomes:
measure: Number of Pain Medication Tablets Used at Home Post-Operatively
timeFrame: 7 days post-operatively
measure: Number of Patients Readmitted to the Hospital
timeFrame: 2 weeks post-operatively
measure: Pain Score
timeFrame: up to 4 hours post operatively
measure: Pain Score at Home Post-Operatively
timeFrame: up to 7 days post operatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Charles Ascher-Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: