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NCT Number: NCT03631160

Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Patients

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.

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Key information

Conditions

Voiding Disorders

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 40 years old and < 75 years old, gender and nationality are not limited;
  • Patients undergoing elective laparoscopic cholecystectomy under general anesthesia
  • agree to participate in this study and sign the informed consent;

Exclusion criteria

  • Refused to participate in this study;
  • laparotomy or preventive indwelling catheter;
  • There are obvious symptoms of urinary difficulty caused by various causes recently;
  • Patients who are have treatment taboo with skin injury or insensitivity to acupoint stimulation.
  • Critical condition (preoperative ASA grade ≥ IV grade); severe renal impairment (need to undergo renal replacement therapy); severe liver and kidney dysfunction (Child-Pugh grade C);
  • There are other circumstances where it is not appropriate to participate in this study

Treatment and study plan

TAES treatmen

Device

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.

Sham TAES treatmen

Device

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 .

Primary outcomes

  1. The first spontaneous voiding after surgery

    Time frame: an average of 1 year

    Record the time from the end of the procedure to the patient's first spontaneous postoperatively, and record the amount of urine and discomfort

Secondary outcomes

  1. symptoms of postoperative voiding

    Time frame: an average of 1 year

    The number of urination, total urine output and possible urinary discomfort symptoms during the perioperative period

  2. postoperative catheterization rate

    Time frame: 12 months

    The incidence of catheterization in patients who were unable to urinate for a long time after surgery

  3. Incidence Urinary tract complications after surgery (including re-hospitalization)

    Time frame: an average of 1 year

    Urinary retention, urinary incontinence, hematuria, urinary tract infection, etc.

  4. NRS pain scores

    Time frame: 12 months

    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.

  5. Anxiety and depression assessment

    Time frame: an average of 1 year

    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.

  6. The effects on postoperative sleep quality scores

    Time frame: 12 months

    Using the NRS method (0 for the best quality of sleep and 10 for the worst quality of sleep)

  7. Length of stay in hospital after surgery

    Time frame: an average of 1 year

    The hospitalization time from the patient's surgery to the time of discharge (excluding re-hospitalization)

Sponsors and collaborators

Lead sponsor

Tianjin Nankai Hospital

Other

Collaborators

  • Anyang People's Hospital
  • Tianjin Beichen Hospital
  • Tianjin First Central Hospital

Registry information

Official study title

Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Cholecystectomy Patients：A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2018
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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