Trial Outcomes & Findings for Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care (NCT NCT04615299)

NCT ID: NCT04615299

Last Updated: 2022-03-18

Results Overview

Patient opioid consumption in the 24 hrs post surgery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2022-03-18

Participant Flow

Participant milestones

Measure	Auricular Acupuncture 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Overall Study STARTED	36	36
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care

Baseline characteristics by cohort

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Race (NIH/OMB) · Black or African American	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Race (NIH/OMB) · White	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Race (NIH/OMB) · Other or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Body Mass Index	30.1 Kg/(m^2) STANDARD_DEVIATION 6.1 • n=5 Participants	28.8 Kg/(m^2) STANDARD_DEVIATION 5.9 • n=7 Participants	29.5 Kg/(m^2) STANDARD_DEVIATION 6.0 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Patient opioid consumption in the 24 hrs post surgery

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Postoperative Opioid Consumption	18.3 Morphine Milligram Equivalent Standard Deviation 12.2	38.6 Morphine Milligram Equivalent Standard Deviation 15.9

PRIMARY outcome

Timeframe: 6 hours

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

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Pain Score Visual Analog Scale (VAS) 6 Hours Post Surgery	4.3 units on a scale Standard Deviation 1.9	6.8 units on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 12 hours

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

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Pain Score Visual Analog Scale (VAS) 12 Hours Post Surgery	3.6 score on a scale Standard Deviation 1.7	5.6 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 18 hours

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

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Pain Score Visual Analog Scale (VAS) 18 Hours Post Surgery	3.1 score on a scale Standard Deviation 1.5	5.6 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery	2.3 score on a scale Standard Deviation 1.4	5.3 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 24 hours

Any patient incidence of vomiting within the 24 hour period post-surgery

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Occurrence of Postoperative Vomiting	0 Participants	11 Participants

SECONDARY outcome

Timeframe: 24 hours

Any reported patient incidence of nausea within the 24 hour period post-surgery

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Occurrence of Postoperative Nausea	1 Participants	13 Participants

SECONDARY outcome

Timeframe: 24 hours

Any patient incidence of postoperative anxiety within the 24 hr period post-surgery

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Occurrence of Postoperative Anxiety	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 24 hours

Patient satisfaction of analgesia scoring from a range of (0% -very unsatisfied to 100% -extremely satisfied)

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Patient Satisfaction	8 score on a scale Interval 4.0 to 8.0	6 score on a scale Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: 24 hours

Any occurrence of acupuncture site infection, acupuncture site bleeding, allergic reaction to acupuncture needles, or scar tissue formation at site of acupuncture needle within the 24-hr period post-surgery

Outcome measures

Measure	Auricular Acupuncture n=36 Participants 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 Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.	Sham Acupuncture n=36 Participants 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. Auricular acupuncture: Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Occurrence of Any Adverse Reactions	0 Participants	0 Participants

Adverse Events

Auricular Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Padmavathi Patel

John Dingell VA Medical Center

Phone: 313-576 2731

Email: Padmavathi.Patel@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place