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Completed

NCT Number: NCT02940288

Acupuncture for Postoperative Analgesia in Laparoscopic Surgery

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.

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Key information

Conditions

Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Veterans Affairs (VA) Medical Center

Atlanta, Georgia, 30033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Auricular Acupuncture

Other

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 Acupuncture

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Acronym: Acu-Pilot

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2016
Registry last updated
Nov 30, 2021

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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