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

Mount Sinai Health System

Status: Completed

Conditions: Post-operative Pain; Gynecological Surgery; Acupuncture

Treatments: Device: Acupuncture needles

Study type: Interventional

Funder types: Other

Identifiers

NCT02855567

GCO 16-1120

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Acupuncture

Active Comparator group

Description:

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.

Treatment:

Device: Acupuncture needles

Sham acupuncture

Sham Comparator group

Description:

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.

Treatment:

Device: Acupuncture needles