1. Title: Effect of Transcutaneous Acupoint Electrical Stimulation on postoperative spontaneous voiding for Laparoscopic Cholecystectomy patients：A Randomized Clinical Trial 2. Research center: Multicenter 3. Design of the research: A randomized, double-blind and parallel controlled study 4. Object of the research: Patients （40≤age\<75 years）planing to elective laparoscopic cholecystectomy under general anesthesia without preoperative placement of catheter. 5. Sample size of the research: A total of 1,200 patients,600 cases in each group 6. Interventions: The acupuncture points for Transcutaneous Acupoint Electrical Stimulation(TAES) are Zhongji ( CV3),Guanyuan ( CV4),Sanyinjiao ( SP6) and Ciliao ( BL32) points . In treatment group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at bilateral of SP6 and BL 32 points during the operation,and treated with a similar method at CV6 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. Each devic is connected and maintained after "Deqi". Participants in the control group received nonacupoints (located 1 inch beside acupoints) and avoided manual stimulation and no "Deqi" without actual current output. 7. Aim of the research: Evaluate the effect of TAES on the postoperative spontaneous voiding in patients for Laparoscopic Cholecystectomy (LC ). 8. Outcome：Primary outcomes: The time of the first spontaneous voiding after surgery . Secondary outcomes: symptoms of postoperative voiding, the incidence of Postoperative dysuria,postoperative catheterization rate, catheterization time, incidence of related complications,as well as the effects on postoperative NRS pain and sleep quality scores etc. 9. The estimated duration of the study：2 years.
This study is a large sample, randomized, double-blinded, placebo-controlled and long-term follow-up design. In this study, bilateralZhongji ( CV3),Guanyuan ( CV4),Sanyinjiao ( SP6) and Ciliao ( BL32) points were selected for perioperative TAES treatment, accompanied with evaluating the postoperative spontaneous voiding, the incidence of Postoperative dysuria,postoperative catheterization rate, as well as the effects on postoperative NRS pain and sleep quality scores . To clarify the effect of TAES on the postoperative spontaneous voiding in patients for laparoscopic surgery is of great significance to the clinical applications and popularization of traditional acupuncture treatment perioperatively across the world.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,948
In the acupoints group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at SP6 and BL 32 points during the operation in the operating room ,and at CV3 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. After "Deqi", electroacupuncture stimulation apparatus is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 \~ 30 milliamp (mA) (gradually increase to the patient's maximum tolerance) and maintained until the end of treatment.
Participants in the acupoints group receive shallow acupointing at SP6, BL 32 ,CV3 and CV4 (nonacupoints located 1 inch beside acupoints, about 20mm).Specifically, the acupoint is shamed without manual stimulation and "Deqi" and the stimulation apparatus is inefficiency without actual current output .
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, China
The first spontaneous voiding after surgery
Record the time from the end of the procedure to the patient's first spontaneous postoperatively, and record the amount of urine and discomfort
Time frame: an average of 1 year
symptoms of postoperative voiding
The number of urination, total urine output and possible urinary discomfort symptoms during the perioperative period
Time frame: an average of 1 year
postoperative catheterization rate
The incidence of catheterization in patients who were unable to urinate for a long time after surgery
Time frame: 12 months
Incidence Urinary tract complications after surgery (including re-hospitalization)
Urinary retention, urinary incontinence, hematuria, urinary tract infection, etc.
Time frame: an average of 1 year
NRS pain scores
NRS method is used to evaluate the pain scores of patients (0 points to complete Painless, 10 points to the maximum pain that can be tolerated) The NRS method was used to evaluate the pain scores of patients at resting state and activity (cough) 6-8 hours after operation.
Time frame: 12 months
Anxiety and depression assessment
Using Hospital Anxiety and Depression Scale (HADS) to evaluate perioperative anxiety and depression of patients.HADS includes two scales of anxiety and depression, of which 0-7 is negative, 8-10 is mild, 11-14 is moderate, and 15-21 is severe.
Time frame: an average of 1 year
The effects on postoperative sleep quality scores
Using the NRS method (0 for the best quality of sleep and 10 for the worst quality of sleep)
Time frame: 12 months
Length of stay in hospital after surgery
The hospitalization time from the patient's surgery to the time of discharge (excluding re-hospitalization)
Time frame: an average of 1 year
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