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

Primary Purpose

Post-operative Pain, Gynecological Surgery, Acupuncture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture needles
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring surgery, acupuncture, gynecology, pain, narcotics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Acupuncture

Sham acupuncture

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Pain Score
Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain
Pain Score at Home Post-Operatively
Pain Score from 0-10 with higher score indicating more pain

Full Information

First Posted
July 29, 2016
Last Updated
June 18, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02855567
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 6, 2016 (Actual)
Primary Completion Date
December 5, 2017 (Actual)
Study Completion Date
December 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Gynecological Surgery, Acupuncture
Keywords
surgery, acupuncture, gynecology, pain, narcotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Acupuncture needles
Intervention Description
Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
Primary Outcome Measure Information:
Title
Morphine Equivalent Usage While in the Hospital
Description
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.
Time Frame
Intra-operative and 24 hours post-operatively
Secondary Outcome Measure Information:
Title
Number of Pain Medication Tablets Used at Home Post-Operatively
Description
Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.
Time Frame
7 days post-operatively
Title
Number of Patients Readmitted to the Hospital
Description
Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.
Time Frame
2 weeks post-operatively
Title
Pain Score
Description
Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain
Time Frame
up to 4 hours post operatively
Title
Pain Score at Home Post-Operatively
Description
Pain Score from 0-10 with higher score indicating more pain
Time Frame
up to 7 days post operatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Ascher-Walsh, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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