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

The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients

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

Study Overview

• Status: Completed
• Conditions: Acupuncture; Post-operative Pain; Gynecological Surgery
• Intervention / Treatment: Device: Acupuncture needles

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Acupuncture needles; Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
Sham Comparator: 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.	Device: Acupuncture needles; Acupuncture needles (29 and 30 gauge) used to perform the acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Equivalent Usage While in the Hospital	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.	Intra-operative and 24 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Pain Medication Tablets Used at Home Post-Operatively	Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.	7 days post-operatively
Number of Patients Readmitted to the Hospital	Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.	2 weeks post-operatively
Pain Score	Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain	up to 4 hours post operatively
Pain Score at Home Post-Operatively	Pain Score from 0-10 with higher score indicating more pain	up to 7 days post operatively

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Charles Ascher-Walsh, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2016
• Primary Completion (Actual): December 5, 2017
• Study Completion (Actual): December 5, 2017

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: pain; surgery; acupuncture; gynecology; narcotics
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: GCO 16-1120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes