Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care

NCT04615299 | Completed Results DMC FDA Device

• 1 other identifier: 060117M1F(V)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that perioperative Auricular (battlefield) acupuncture for general surgery and urology cases undergoing general anesthesia will decrease opioid requirements, postoperative pain, the incidence of PONV, and the incidence of perioperative anxiety in comparison to simulated (placebo) perioperative battlefield acupuncture.

Conditions

Acupuncture, Ear

Outcome Measures

Primary Outcomes (5)

• Postoperative Opioid Consumption

  Patient opioid consumption in the 24 hrs post surgery

  24 hours

• Pain Score Visual Analog Scale (VAS) 6 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  6 hours

• Pain Score Visual Analog Scale (VAS) 12 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  12 hours

• Pain Score Visual Analog Scale (VAS) 18 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  18 hours

• Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  24 hours

Secondary Outcomes (5)

• Occurrence of Postoperative Vomiting

  24 hours

• Occurrence of Postoperative Nausea

  24 hours

• Occurrence of Postoperative Anxiety

  24 hours

• Patient Satisfaction

  24 hours

• Occurrence of Any Adverse Reactions

  24 hours

Study Arms (2)

Auricular acupuncture

ACTIVE COMPARATOR

Auricular (Battlefield) acupuncture needles will be utilized in the test arm, location of needles and stickers will be placed according to 5 VA approved BFA auricular acupuncture points associated with PONV, pain, and anxiety respectively

Device: Auricular acupuncture

Sham acupuncture

SHAM COMPARATOR

The control arm will receive sham or placebo acupuncture via pressing of a blunt needle on the specified BFA locations and then application of adhesive stickers. In the control group simulating acupuncture, the needles will never enter the patients' skin and will give the impression to the patient that the procedure has taken place.

Device: Auricular acupuncture

Interventions

Auricular acupuncture DEVICE

Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.

Auricular acupuncture; Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an American Society of Anesthesiologists (ASA) Physical Status classification of 1 to 4 2 - Patients aged between 18 and 100 scheduled to undergo scheduled suitable inpatient/outpatient cases under anesthesia.
• Patients must be willing and fit to give written informed consent 4 - Inpatient stay required

You may not qualify if:

• \- Coagulopathies
• \- Patients with continuous epidural
• \- Uncooperative patient
• \- Psychiatric disorders and language deficiencies that may interfere with the assessment of pain
• \- Insufficient understanding of the pain scoring system.
• \- Outpatient stay

Sponsors & Collaborators

• Anesthesiology WSU/DMC-NorthStar: lead
• John D. Dingell VA Medical Center: collaborator

Study Sites (1)

John D. Dingell VA Medical Center

Detroit, Michigan, 48201, United States

Location

Related Publications (2)

• Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227.

  PMID: 26170347 BACKGROUND

• Fleckenstein J, Baeumler PI, Gurschler C, Weissenbacher T, Simang M, Annecke T, Geisenberger T, Irnich D. Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial. Trials. 2014 Jul 21;15:292. doi: 10.1186/1745-6215-15-292.

  PMID: 25047046 BACKGROUND

MeSH Terms

Interventions

Acupuncture, Ear

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Results Point of Contact

• Title: Dr Padmavathi Patel
• Organization: John Dingell VA Medical Center

Padmavathi.Patel@va.gov

313-576 2731

Study Officials

• Padmavathi Patel, MD

  Wayne State University, John D. Dingell VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sham acupuncture covers will be placed on control participants
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The treatment group (Group 1) will receive postoperative auricular battlefield acupuncture. The control group (Group 2) will receive sham (placebo) postoperative auricular battlefield acupuncture.

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: June 6, 2018
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)