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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02855567
Other study ID # GCO 16-1120
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 6, 2016
Est. completion date December 5, 2017

Study information

Verified date June 2019
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date December 5, 2017
Est. primary completion date December 5, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Pain Score at Home Post-Operatively Pain Score from 0-10 with higher score indicating more pain up to 7 days post operatively
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