Acupuncture for Postoperative Analgesia in Laparoscopic Surgery (Acu-Pilot)

November 29, 2021 updated by: Yanire Nieves, Emory University

Auricular (ear) acupuncture treatment involves placing filiform needles in the ears at particular locations called acupoints. Although the mechanism for acupuncture analgesia is still unclear, it is believed ear acupoints work like reflex points that once stimulated with penetration by a needle have the ability to relieve pain in a different part of the body.

The purpose of this study is to explore the safety and effects of auricular acupuncture therapy on postoperative analgesic consumption and pain scores immediately following laparoscopic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Auricular acupuncture is a diagnostic and treatment system associated with a somatotopic representation of the homunculus in the ear. This acupuncture technique is similar, in theory, to reflexology where stimulation of a reflex point in the ear is presumed to relieve symptoms in another part of the body. It is hypothesized that this technique works to decrease pain through the reticular formation, the sympathetic and the parasympathetic nervous systems.

The increasing use of laparoscopic surgery has significantly diminished the dosing and duration of postoperative opioid consumption compared with open surgery. However, adverse events related with opioid use (nausea & vomiting, pruritus, urinary retention, sedation) may cause delays in hospital discharge and can be especially problematic for certain sub-sets of high risk patients such as those with obstructive sleep apnea or prior histories of addiction. Investigators hypothesize that auricular acupuncture using the Battlefield Acupuncture Protocol will decrease opioid consumption and postoperative pain after laparoscopic surgery with minimal or no adverse events.

The primary aim of this study is to assess the effects of the BFA protocol on postoperative analgesic consumption and the secondary aims are to assess pain scores and time to discharge from Post Anesthesia Care Unit following laparoscopic surgery.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Atlanta Veterans Affairs (VA) Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing laparoscopic surgery for cholecystectomy, hysterectomy or hernia repair
  • Patients naïve to acupuncture

Exclusion Criteria:

  • Pregnancy
  • Bleeding disorder
  • Anticoagulant medications
  • Involuntary movement disorders/Seizure disorders
  • Local auricular infection, loss of skin integrity or significant deformation
  • History of opioid medication use or dependence
  • Hemodynamic or immunocompromised status
  • History of syncope with venipuncture
  • Unable to understand the consent form or how to use the VAS-100
  • Prosthetic cardiac valves
  • Patients will be withdrawn from the study if surgery time exceeds 90 minutes or the laparoscopic procedure turned into an open surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants will be randomized to receive bilateral auricular acupuncture for postoperative pain.
Other: Auricular Acupuncture
Participants will receive bilateral auricular acupuncture using the Battlefield Acupuncture (BFA) protocol while in the Post Analgesia Care Unit (PACU) following laparoscopic surgery. Acupuncture needles will be left in place for 30 minutes.
Sham Comparator: Control
Participants will be randomized to receive bilateral sham acupuncture.
Other: Sham Acupuncture
Participants will receive sham acupuncture while in the Post Analgesia Care Unit (PACU) following laparoscopic surgery. During the sham procedure, needles will be inserted bilaterally in five nonspecific ear acupoints. Acupuncture needles will be left in place for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Analgesic Request
Time Frame: Post Surgery (Up to 30 minutes)
The time to request for analgesia will be collected from the participant's postoperative anesthesia care unit (PACU) records.
Post Surgery (Up to 30 minutes)
Total Amount of Postoperative Pain Medication
Time Frame: Post Surgery (Up to 2 Hours)
The total amount of pain medication taken up to two hours post surgery will be collected from the participant's postoperative anesthesia care unit (PACU) records.
Post Surgery (Up to 2 Hours)
Pain Intensity assessed by the Visual Analog Scale (VIS)
Time Frame: Post Surgery (Up to 2 Hours)
Pain intensity will be recorded using the modified 100mm visual analog scale. This scale rates pain from 0 to 100 with 0 meaning no pain at all and 100 is the most severe pain.
Post Surgery (Up to 2 Hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Discharge
Time Frame: Post Surgery (Up to 2 Hours)
Time to discharge from the postoperative anesthesia care unit (PACU) will be collected from the participant's record.
Post Surgery (Up to 2 Hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Yanire Nieves, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

November 22, 2019

Study Completion (Actual)

November 22, 2019

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00086184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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