NCT02940288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

3.2 years

First QC Date

October 19, 2016

Last Update Submit

November 29, 2021

Conditions

Surgery

Outcome Measures

Primary Outcomes (3)

  • Time to First Analgesic Request

    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

    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)

    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 Outcomes (1)

  • Time to Discharge

    Post Surgery (Up to 2 Hours)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will be randomized to receive bilateral auricular acupuncture for postoperative pain.

Other: Auricular Acupuncture

Control

SHAM COMPARATOR

Participants will be randomized to receive bilateral sham acupuncture.

Other: Sham Acupuncture

Interventions

Auricular AcupunctureOTHER

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.

Intervention
Sham AcupunctureOTHER

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.

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta Veterans Affairs (VA) Medical Center

Atlanta, Georgia, 30033, United States

Location

Related Publications (16)

  • Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.

    PMID: 24436674BACKGROUND

  • Sun Y, Gan TJ, Dubose JW, Habib AS. Acupuncture and related techniques for postoperative pain: a systematic review of randomized controlled trials. Br J Anaesth. 2008 Aug;101(2):151-60. doi: 10.1093/bja/aen146. Epub 2008 Jun 2.

    PMID: 18522936BACKGROUND

  • Gori L, Firenzuoli F. Ear acupuncture in European traditional medicine. Evid Based Complement Alternat Med. 2007 Sep;4(Suppl 1):13-6. doi: 10.1093/ecam/nem106.

    PMID: 18227925BACKGROUND

  • Han JS. Acupuncture and endorphins. Neurosci Lett. 2004 May 6;361(1-3):258-61. doi: 10.1016/j.neulet.2003.12.019.

    PMID: 15135942BACKGROUND

  • Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021.

    PMID: 15777857BACKGROUND

  • Crespin DJ, Griffin KH, Johnson JR, Miller C, Finch MD, Rivard RL, Anseth S, Dusek JA. Acupuncture provides short-term pain relief for patients in a total joint replacement program. Pain Med. 2015 Jun;16(6):1195-203. doi: 10.1111/pme.12685. Epub 2015 Jan 13.

    PMID: 25586769BACKGROUND

  • Goertz CM, Niemtzow R, Burns SM, Fritts MJ, Crawford CC, Jonas WB. Auricular acupuncture in the treatment of acute pain syndromes: A pilot study. Mil Med. 2006 Oct;171(10):1010-4. doi: 10.7205/milmed.171.10.1010.

    PMID: 17076456BACKGROUND

  • Han JS, Tang J, Ren MF, Zhou ZF, Fan SG, Qiu XC. Central neurotransmitters and acupuncture analgesia. Am J Chin Med. 1980 Winter;8(4):331-48. doi: 10.1142/s0192415x80000311.

    PMID: 6113756BACKGROUND

  • Grube T, Uhlemann C, Weiss T, Meissner W. [Influence of acupuncture on postoperative pain, nausea and vomiting after visceral surgery : a prospective, randomized comparative study of metamizole and standard treatment]. Schmerz. 2009 Aug;23(4):370-6. doi: 10.1007/s00482-009-0798-1. German.

    PMID: 19513760BACKGROUND

  • Usichenko TI, Kuchling S, Witstruck T, Pavlovic D, Zach M, Hofer A, Merk H, Lehmann C, Wendt M. Auricular acupuncture for pain relief after ambulatory knee surgery: a randomized trial. CMAJ. 2007 Jan 16;176(2):179-83. doi: 10.1503/cmaj.060875.

    PMID: 17224599BACKGROUND

  • Usichenko TI, Hermsen M, Witstruck T, Hofer A, Pavlovic D, Lehmann C, Feyerherd F. Auricular Acupuncture for Pain Relief after Ambulatory Knee Arthroscopy-A Pilot Study. Evid Based Complement Alternat Med. 2005 Jun;2(2):185-189. doi: 10.1093/ecam/neh097. Epub 2005 May 11.

    PMID: 15937559BACKGROUND

  • Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.

    PMID: 25435890BACKGROUND

  • Lewith GT, Machin D. On the evaluation of the clinical effects of acupuncture. Pain. 1983 Jun;16(2):111-127. doi: 10.1016/0304-3959(83)90202-6.

    PMID: 6348651BACKGROUND

  • Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.

    PMID: 24138333BACKGROUND

  • Bohnert AS, Ilgen MA, Galea S, McCarthy JF, Blow FC. Accidental poisoning mortality among patients in the Department of Veterans Affairs Health System. Med Care. 2011 Apr;49(4):393-6. doi: 10.1097/MLR.0b013e318202aa27.

    PMID: 21407033BACKGROUND

  • Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. No abstract available.

    PMID: 26760086BACKGROUND

Related Links

MeSH Terms

Interventions

Acupuncture, Ear

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Officials

  • Yanire Nieves, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 20, 2016

Study Start

September 1, 2016

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)