Electrical Acupoint Stimulation for Postoperative Recovery (EAS)

Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.

This study investigates electrical acupoint stimulation (EAS) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. the surgery cause to change of stress response, which might be associated with postoperative recovery of patient Totally, three groups are created, 1/3 participants receive transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture, the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Postoperative Delirium; Deep Vein Thrombosis; Postoperative Infection; Postoperative Nausea and Vomiting; Postoperative Pneumonia; Postoperative Recovery; Postoperative Retention of Urine
• Intervention / Treatment: Device: Transcutaneous Electrical Acupoint Stimulation; Device: Electroacupuncture; Device: sham Transcutaneous Electrical Acupoint Stimulation

Detailed Description

Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to recovery of patients, reduce the incidence of postoperative complications. The main possible mechanism was stress response regulation. The hypothesis is that the EAS improve postoperative recovery of patient through regulating stress response.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Ji'nan, Shandong, China, 250011
      • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Agree to sign the contract
• The patients receive total hip or knee arthroplasty
• Epidural anesthesia administered

Exclusion Criteria:

• The patients' age out of range setting
• Forbidden to the administration of transcutaneous electrical acupoint stimulation
• Communication disorder
• The patients who had medical history of cerebral vascular diseases, deep vein thrombosis, urinary retention, nausea and vomiting.
• The patients who attended another trial in the past three months
• Emergency surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEAS group; Transcutaneous Electrical Acupoint Stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao. Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.	Device: Transcutaneous Electrical Acupoint Stimulation; The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
Placebo Comparator: Electroacupuncture group; Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.	Device: Electroacupuncture; The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
Sham Comparator: sham TEAS group; Sham transcutaneous electrical acupoint stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao; Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.	Device: sham Transcutaneous Electrical Acupoint Stimulation; The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The postoperative recovery	Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The adverse event	Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al.	7 days
The level of stress response	Assess the level of preoperative stress response at 1, 3, 7 days after operation. It mainly include Adrenocorticotropic Hormone (ACTH), Cortisol (COR), Adrenaline (E), norepinephrine (NE). All measures unit is pg/ml.	up to 7 days
Postoperative complications	Record the incidence of any postoperative complications during 7 days	7 days
The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10	Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation. It mainly include Tumor Necrosis Factor-a (TNF-a), Interleukins-1 (IL-1), Interleukins-6 (IL-6), Interleukins-10 (IL-10). All measures unit is ng/ml.	up to 7 days
The level of inflammatory response by C-reactive protein	Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L.	up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age in years	Once patients enrolled, the age (years) need to be recorded ahead of operation.	1 day
ASA classification status	Once patients enrolled, the ASA condition need to be recorded ahead of operation depend on the ASA classification.	1 day
Gender	Once patients enrolled, the gender need to be recorded ahead of operation.	1 day
Weight in kilograms	Once patients enrolled, the weight (kilograms) need to be recorded ahead of operation.	1 day
Height in meters	Once patients enrolled, the height (meters) need to be recorded ahead of operation.	1 day
BMI in kg/m^2	Once patients enrolled, the BMI (weight and height will be combined to report BMI in kg/m^2) will be reported base on weight and height ahead of operation.	1 day

Collaborators and Investigators

• Sponsor: Shandong University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Su Fan, MD, Shandong University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Coburn M, Fahlenkamp A, Zoremba N, Schaelte G. Postoperative cognitive dysfunction: Incidence and prophylaxis. Anaesthesist. 2010 Feb;59(2):177-84; quiz 185. doi: 10.1007/s00101-009-1657-2.
• Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430.
• Office of the Surgeon General (US); National Heart, Lung, and Blood Institute (US). The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Rockville (MD): Office of the Surgeon General (US); 2008. Available from http://www.ncbi.nlm.nih.gov/books/NBK44178/
• Montazeri AS, Hamidzadeh A, Raei M, Mohammadiun M, Montazeri AS, Mirshahi R, Rohani H. Evaluation of Oral Ginger Efficacy against Postoperative Nausea and Vomiting: A Randomized, Double - Blinded Clinical Trial. Iran Red Crescent Med J. 2013 Dec;15(12):e12268. doi: 10.5812/ircmj.12268. Epub 2013 Dec 5.
• Sorrell JM. Postoperative cognitive dysfunction in older adults: a call for nursing involvement. J Psychosoc Nurs Ment Health Serv. 2014 Nov;52(11):17-20. doi: 10.3928/02793695-20141021-03.
• Ge Y, Ma Z, Shi H, Zhao Y, Gu X, Wei H. [Incidence and risk factors of postoperative cognitive dysfunction in patients underwent coronary artery bypass grafting surgery]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2014 Oct;39(10):1049-55. doi: 10.11817/j.issn.1672-7347.2014.10.011. Chinese.
• Tsay SL, Cho YC, Chen ML. Acupressure and Transcutaneous Electrical Acupoint Stimulation in improving fatigue, sleep quality and depression in hemodialysis patients. Am J Chin Med. 2004;32(3):407-16. doi: 10.1142/S0192415X04002065.
• Kabalak AA, Akcay M, Akcay F, Gogus N. Transcutaneous electrical acupoint stimulation versus ondansetron in the prevention of postoperative vomiting following pediatric tonsillectomy. J Altern Complement Med. 2005 Jun;11(3):407-13. doi: 10.1089/acm.2005.11.407.
• Yao Y, Zhao Q, Gong C, Wu Y, Chen Y, Qiu L, Wu X, Chen Y. Transcutaneous Electrical Acupoint Stimulation Improves the Postoperative Quality of Recovery and Analgesia after Gynecological Laparoscopic Surgery: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:324360. doi: 10.1155/2015/324360. Epub 2015 Jun 11.
• Zheng LH, Sun H, Wang GN, Liang J, Wu HX. Effect of transcutaneous electrical acupoint stimulation on nausea and vomiting induced by patient controlled intravenous analgesia with tramadol. Chin J Integr Med. 2008 Mar;14(1):61-4. doi: 10.1007/s11655-007-9006-2.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): October 30, 2019

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative Complications; postoperative recovery; Peri-operation; Acupoint Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Signs and Symptoms, Digestive; Urination Disorders; Embolism and Thrombosis; Nausea; Vomiting; Thrombosis; Venous Thrombosis; Postoperative Complications; Urinary Retention; Postoperative Nausea and Vomiting
• Other Study ID Numbers: SZH-A-20170501-R2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD sharing content included the intervention protocol, record or data collected for the primary and secondary outcome measures.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion, forever.
• IPD Sharing Access Criteria: Anyone are available to access the data collected on this website with requiring to sign the Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No