Clinical trial NCT03249701: Electrical Acupoint Stimulation for Postoperative Recovery
Official title: Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Postoperative Nausea and Vomiting
Postoperative Infection
Postoperative Delirium
Postoperative Pneumonia
Deep Vein Thrombosis
Postoperative Retention of Urine
Postoperative Recovery
Keywords: Acupoint Stimulation
postoperative recovery
Postoperative Complications
Peri-operation
Lead sponsor: Shandong University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants divided into 3 groups randomized, one group receive transcutaneous electrical acupoint stimulation, one group receive electroacupuncture, the third group only connect to acupoints without stimulation.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The postoperative recovery
timeFrame: 7 days
Secondary outcomes:
measure: The adverse event
timeFrame: 7 days
measure: The level of stress response
timeFrame: up to 7 days
measure: Postoperative complications
timeFrame: 7 days
measure: The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10
timeFrame: up to 7 days
measure: The level of inflammatory response by C-reactive protein
timeFrame: up to 7 days
Other outcomes:
measure: Age in years
timeFrame: 1 day
measure: ASA classification status
timeFrame: 1 day
measure: Gender
timeFrame: 1 day
measure: Weight in kilograms
timeFrame: 1 day
measure: Height in meters
timeFrame: 1 day
measure: BMI in kg/m^2
timeFrame: 1 day
Locations:
city: Ji'nan
country: China
facility: Affiliated hospital of shandong university of traditional chinese medicine
state: Shandong
Study officials:
affiliation: Shandong University of Traditional Chinese Medicine
name: Su Fan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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