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SurgeryAcu-PilotNCT02940288

Acupuncture for Postoperative Analgesia in Laparoscopic Surgery

A study testing Auricular Acupuncture in people with Surgery, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Surgery
What is being tested?
Auricular Acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 2016to 22 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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  • Patients will be withdrawn from the study if surgery time exceeds 90 minutes or the laparoscopic procedure turned into an open surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atlanta Veterans Affairs (VA) Medical Center

    Atlanta, Georgia, 30033

Other trials in United States

About this study

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.

Read the 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.

Conditions
Surgery
Being tested
Auricular Acupuncture, Sham Acupuncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT02940288
Study groupRoleWhat they receive
InterventionExperimentalParticipants will be randomized to receive bilateral auricular acupuncture for postoperative pain.
Receives: Other: Auricular Acupuncture
ControlSham comparatorParticipants will be randomized to receive bilateral sham acupuncture.
Receives: Other: Sham Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Analgesic Request

    The time to request for analgesia will be collected from the participant's postoperative anesthesia care unit (PACU) records.

    Measured: Post Surgery (Up to 30 minutes)

  2. 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.

    Measured: Post Surgery (Up to 2 Hours)

  3. 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.

    Measured: Post Surgery (Up to 2 Hours)

Secondary outcomes (1)

  1. Time to Discharge

    Time to discharge from the postoperative anesthesia care unit (PACU) will be collected from the participant's record.

    Measured: Post Surgery (Up to 2 Hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion22 Nov 2019
  4. Study completion22 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02940288
Sponsor's protocol ID
IRB00086184
Acronym
Acu-Pilot
Status last verified
Nov 2021
First submitted
19 Oct 2016
Last updated
30 Nov 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

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

    PubMed 24436674

  • 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.

    PubMed 18522936

  • 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.

    PubMed 18227925

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

    PubMed 15135942

  • 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.

    PubMed 15777857

  • 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.

    PubMed 25586769

  • 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.

    PubMed 17076456

  • 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.

    PubMed 6113756

  • 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.

    PubMed 19513760

  • 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.

    PubMed 17224599

  • 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.

    PubMed 15937559

  • 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.

    PubMed 25435890

  • 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.

    PubMed 6348651

  • 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.

    PubMed 24138333

  • 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.

    PubMed 21407033

Questions about this trial

What is this clinical trial studying?

A study testing Auricular Acupuncture in people with Surgery, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Analgesic Request (time frame: Post Surgery (Up to 30 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02940288, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.

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