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

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ClinicalTrials.gov Identifier: NCT02855567
Recruitment Status : Completed
First Posted : August 4, 2016
Results First Posted : June 19, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
Post-operative Pain Gynecological Surgery Acupuncture Device: Acupuncture needles Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
Actual Study Start Date : August 6, 2016
Actual Primary Completion Date : December 5, 2017
Actual Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Morphine Equivalent Usage While in the Hospital [ Time Frame: Intra-operative and 24 hours post-operatively ]
    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 :
  1. Number of Pain Medication Tablets Used at Home Post-Operatively [ Time Frame: 7 days post-operatively ]
    Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.

  2. Number of Patients Readmitted to the Hospital [ Time Frame: 2 weeks post-operatively ]
    Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.

  3. Pain Score [ Time Frame: up to 4 hours post operatively ]
    Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain

  4. Pain Score at Home Post-Operatively [ Time Frame: up to 7 days post operatively ]
    Pain Score from 0-10 with higher score indicating more pain



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855567


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Charles Ascher-Walsh, MD Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Icahn School of Medicine at Mount Sinai:

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02855567     History of Changes
Other Study ID Numbers: GCO 16-1120
First Posted: August 4, 2016    Key Record Dates
Results First Posted: June 19, 2019
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
surgery
acupuncture
gynecology
pain
narcotics

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms