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

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855567
• Other study ID #: GCO 16-1120
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acupuncture
• Gynecological Surgery
• Pain, Postoperative
• Post-operative Pain

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