Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04615299
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2020-10-29
Brief Title:
Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care
Sponsor:
Anesthesiology WSUDMC-NorthStar
Organization:
Anesthesiology WSUDMC-NorthStar
Study Overview
Official Title:
Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BFA
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
Detailed Description:
INTRODUCTION
Battlefield acupuncture is an auricular therapy that has been used for centuries with roots tied to Eastern Asian medicine Ease of application low cost and minimal side effects make battlefield acupuncture a perioperative modality that has been linked to decreased morbidity and mortality in patients undergoing surgical procedures and anesthesia 1 In the United States there is pressure by the government and the medical community to decrease opioid use especially in the perioperative time period Opiate use due to postoperative pain postoperative nausea and vomiting PONV perioperative anxiety have all been linked to an increased hospital stay increased morbidity and mortality and ultimately higher healthcare costs 2 Anesthesia providers can be trained in the application of acupuncture in the perioperative time period Through analysis of rates of postoperative opioid use postoperative nausea and vomiting and perioperative anxiety the efficacy and utility of battlefield acupuncture will be realized as an effective adjunct to multimodal anesthesia care
STUDY DESIGN AND METHODS
This will be a prospective randomized study to compare auricular battlefield acupuncture to sham auricular battlefield acupuncture in patients undergoing general surgery and urology cases with general anesthesia Participants in the study will be randomly assigned to either receive auricular battlefield acupuncture treatment group or simulated placebo control group auricular battlefield acupuncture Battlefield acupuncture needles will be utilized in the test arm and blunt needle pressing and covering with acupuncture stickers will be utilized in the control arm as a sham treatment Location of needles and stickers will be placed according to 5 VA approved BFA auricular acupuncture points associated with PONV pain and anxiety respectively Figure 1 3 In both arms the treatment ear will be covered after treatment so as to blind the patient Both battlefield acupuncture and control groups will receive small band aids on the battlefield acupuncture needle sites Both the evaluators for post procedure assessment along with the patient will be blinded in regards to what group they are in
Inclusion Criteria
1- 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 inpatientoutpatient cases under anesthesia
3 - Patients must be willing and fit to give written informed consent 4 - Inpatient stay required
Exclusion Criteria
1 - Coagulopathies
2 - Patients with continuous epidural
3 - Uncooperative patient
4 - Psychiatric disorders and language deficiencies that may interfere with the assessment of pain
5 - Insufficient understanding of the pain scoring system
6 - Outpatient stay
This study will be performed at the John D Dingell VA Medical Center Only a trained MD anesthesiologist will recruit patient in the preoperative period where informed consent will be obtained Computerized randomization will take place at the time the patient presents for surgery Consent will be taken preoperatively
Anesthetic Plan
The anesthetic management will be general anesthesia with the provision of intravenous opioids intraoperatively and during recovery Fentanyl will be the sole intra operative opioid No other alterations of anesthetic management will take place pre or intra operatively The battlefield acupuncture or sham battlefield acupuncture will be placed in the postoperative care unit PACU
Acupuncture Plan
Typically acupuncture needles which are semi-permanent needles have the characteristics of remaining in the ear acupoints for up to 3-4 days before being pushed out toward to the surface by the previous flattened epidermis The test arm treatment group will received actual acupuncture needles while the control arm will received 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 The ear treated will be covered with a bandage via non-skin sensitive tape so as to blind the patient to which treatment group they are in
Statistical Analysis
An unpaired students-t-test procedure two-sample assuming equal variances two-tail significance p005 95 confidence interval was performed to examine mean differences between the two study groups on all continuously scaled variables A Repeated measures ANOVA will be used to measured differences between time for continuous variables at the 2 measured time points 1 hour and 24 hours Assumptions of normality andor homogeneity of variance will be checked and verified Comparisons between study groups on proportional differences will be examined using a non-parametric Fishers Exact Chi-square test when applied to 2x2 tables Statistical significance will be set at a p-value 005 All continuous data will be expressed as the mean with 95 upper and lower confidence intervals or Mean Standard deviation
A binary outcome superiority power analysis based on a rate of 33 reduction of opioid consumption in the auricular battlefield acupuncture group compared to controls sham auricular battlefield acupuncture concluded 72 participants 36 patients per group would be necessary to achieve 80 power with a p005
Battlefield acupuncture is an auricular therapy that has been used for centuries with roots tied to Eastern Asian medicine Ease of application low cost and minimal side effects make battlefield acupuncture a perioperative modality that has been linked to decreased morbidity and mortality in patients undergoing surgical procedures and anesthesia 1 In the United States there is pressure by the government and the medical community to decrease opioid use especially in the perioperative time period Opiate use due to postoperative pain postoperative nausea and vomiting PONV perioperative anxiety have all been linked to an increased hospital stay increased morbidity and mortality and ultimately higher healthcare costs 2 Anesthesia providers can be trained in the application of acupuncture in the perioperative time period Through analysis of rates of postoperative opioid use postoperative nausea and vomiting and perioperative anxiety the efficacy and utility of battlefield acupuncture will be realized as an effective adjunct to multimodal anesthesia care
STUDY DESIGN AND METHODS
This will be a prospective randomized study to compare auricular battlefield acupuncture to sham auricular battlefield acupuncture in patients undergoing general surgery and urology cases with general anesthesia Participants in the study will be randomly assigned to either receive auricular battlefield acupuncture treatment group or simulated placebo control group auricular battlefield acupuncture Battlefield acupuncture needles will be utilized in the test arm and blunt needle pressing and covering with acupuncture stickers will be utilized in the control arm as a sham treatment Location of needles and stickers will be placed according to 5 VA approved BFA auricular acupuncture points associated with PONV pain and anxiety respectively Figure 1 3 In both arms the treatment ear will be covered after treatment so as to blind the patient Both battlefield acupuncture and control groups will receive small band aids on the battlefield acupuncture needle sites Both the evaluators for post procedure assessment along with the patient will be blinded in regards to what group they are in
Inclusion Criteria
1- 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 inpatientoutpatient cases under anesthesia
3 - Patients must be willing and fit to give written informed consent 4 - Inpatient stay required
Exclusion Criteria
1 - Coagulopathies
2 - Patients with continuous epidural
3 - Uncooperative patient
4 - Psychiatric disorders and language deficiencies that may interfere with the assessment of pain
5 - Insufficient understanding of the pain scoring system
6 - Outpatient stay
This study will be performed at the John D Dingell VA Medical Center Only a trained MD anesthesiologist will recruit patient in the preoperative period where informed consent will be obtained Computerized randomization will take place at the time the patient presents for surgery Consent will be taken preoperatively
Anesthetic Plan
The anesthetic management will be general anesthesia with the provision of intravenous opioids intraoperatively and during recovery Fentanyl will be the sole intra operative opioid No other alterations of anesthetic management will take place pre or intra operatively The battlefield acupuncture or sham battlefield acupuncture will be placed in the postoperative care unit PACU
Acupuncture Plan
Typically acupuncture needles which are semi-permanent needles have the characteristics of remaining in the ear acupoints for up to 3-4 days before being pushed out toward to the surface by the previous flattened epidermis The test arm treatment group will received actual acupuncture needles while the control arm will received 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 The ear treated will be covered with a bandage via non-skin sensitive tape so as to blind the patient to which treatment group they are in
Statistical Analysis
An unpaired students-t-test procedure two-sample assuming equal variances two-tail significance p005 95 confidence interval was performed to examine mean differences between the two study groups on all continuously scaled variables A Repeated measures ANOVA will be used to measured differences between time for continuous variables at the 2 measured time points 1 hour and 24 hours Assumptions of normality andor homogeneity of variance will be checked and verified Comparisons between study groups on proportional differences will be examined using a non-parametric Fishers Exact Chi-square test when applied to 2x2 tables Statistical significance will be set at a p-value 005 All continuous data will be expressed as the mean with 95 upper and lower confidence intervals or Mean Standard deviation
A binary outcome superiority power analysis based on a rate of 33 reduction of opioid consumption in the auricular battlefield acupuncture group compared to controls sham auricular battlefield acupuncture concluded 72 participants 36 patients per group would be necessary to achieve 80 power with a p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None