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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02940288
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Yanire Nieves, Emory University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Surgery Other: Auricular Acupuncture Other: Sham Acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Postoperative Analgesia in Laparoscopic Surgery
Study Start Date : September 2016
Actual Primary Completion Date : November 22, 2019
Actual Study Completion Date : November 22, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02940288


Locations
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United States, Georgia
Atlanta Veterans Affairs (VA) Medical Center
Atlanta, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Yanire Nieves, MD Emory University
Additional Information:
Publications:

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Responsible Party: Yanire Nieves, Instructor, Emory University
ClinicalTrials.gov Identifier: NCT02940288    
Other Study ID Numbers: IRB00086184
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No