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

NCT ID: NCT02855567

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-06
• Study Completion Date: 2017-12-05

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.

Conditions

Post-operative Pain; Gynecological Surgery; Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture

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.

Group Type: ACTIVE_COMPARATOR

Acupuncture needles

Intervention Type: DEVICE

Acupuncture needles (29 and 30 gauge) used to perform the acupuncture

Sham acupuncture

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.

Group Type: SHAM_COMPARATOR

Acupuncture needles

Intervention Type: DEVICE

Acupuncture needles (29 and 30 gauge) used to perform the acupuncture

Interventions

Acupuncture needles

Acupuncture needles (29 and 30 gauge) used to perform the acupuncture

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Ascher-Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 16-1120

Identifier Type: -

Identifier Source: org_study_id