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

NCT02855567 | Completed Results FDA Device

• 1 other identifier: GCO 16-1120
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-operative Pain; Gynecological Surgery; Acupuncture

Keywords

surgery; acupuncture; gynecology; pain; narcotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Pain Medication Tablets Used at Home Post-Operatively

  7 days post-operatively

• Number of Patients Readmitted to the Hospital

  2 weeks post-operatively

• Pain Score

  up to 4 hours post operatively

• Pain Score at Home Post-Operatively

  up to 7 days post operatively

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

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

Sham acupuncture

SHAM COMPARATOR

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

Interventions

Acupuncture needles DEVICE

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

Acupuncture; Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients
• over the age of 18
• scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Charles Ascher-Walsh
• Organization: Icahn School of Medicine at Mount Sinai

Charles.ascher-walsh@mssm.edu

212-241-2827

Study Officials

• Charles Ascher-Walsh, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 4, 2016
• Study Start: August 6, 2016
• Primary Completion: December 5, 2017
• Study Completion: December 5, 2017
• Last Updated: June 25, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)