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Completed

NCT Number: NCT02855567

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture needles

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2016
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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