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Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy

Primary Purpose

Pain Postoperative, Postoperative Recovery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous electrical acupoint stimulatios
Bilateral transverse abdominal plane block
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain Postoperative focused on measuring Transcutaneous electrical acupoint stimulation, Postoperative pain, Visceral pain, Early recovery after surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) class I and II Age 18-65 years Laparoscopic cholecystectomy for the first time There is no rupture, infection in the acupoint pasting site The patient knows and signs the informed consent form Exclusion Criteria: People with visual impairment, hearing impairment and alcoholism History of diabetes, myocardial infarction or cerebrovascular accident, liver and kidney dysfunction Those who are allergic to non-steroidal drugs, anticholinergic drugs, and anesthetic drugs Those who are unable to cooperate or refuse to participate in the research or request to withdraw during the research process Those with contraindications to percutaneous electrical stimulation, including local skin damage, infection or implantation of electrophysiological devices in the body

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    TT group

    TE group

    TA group

    C group

    Arm Description

    Bilateral Neiguan acupuncture points (PC6), Hegu acupuncture points (LI4), Zusanli (ST36) were selected, and percutaneous acupuncture points were electrically stimulated with electronic acupuncture equipment 30min before anesthesia, and then bilateral abdominal transverse plane blockade was performed

    Bilateral Neiguan acupuncture points (PC6), Hegu acupuncture points (LI4), Zusanli (ST36) were selected, and percutaneous acupuncture points were electrically stimulated with electronic acupuncture equipment 30min before anesthesia

    Bilateral transverse abdominal plane block is performed prior to anesthesia

    Percutaneous electrical stimulation of acupoints and transverse abdominis plane block are not permitted before anesthesia

    Outcomes

    Primary Outcome Measures

    VAS(visual analogue scale) score
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    VAS(visual analogue scale) score
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    VAS(visual analogue scale) score
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    VAS(visual analogue scale) score
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    VAS(visual analogue scale) score
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    VAS(visual analogue scale) score
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.

    Secondary Outcome Measures

    Postoperative nausea and vomiting
    After surgery, patients are asked about nausea and vomiting. Postoperative nausea and vomiting is assessed after surgery by using visual analogue scoring. Using a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no nausea and vomiting, and 10 points represent the most severe nausea and vomiting that is unbearable.
    Early postoperative recovery of quality
    The quality of early postoperative recovery was assessed using The Quality of Recovery-15 scale after surgery, scores range from 0 (QoR very poor) to 150 (QoR excellent), with higher scores representing better quality of recovery
    Exhaust and bowel movements
    Record the time of the patient's first exhaust bowel movement after surgery
    Concentration of serum interleukin-6
    Perioperative venous blood was drawn to detect serum interleukin-6
    Concentration of serum cortisol
    Perioperative venous blood was drawn to detect serum cortisol
    Concentration of serum C-reactive protein
    Perioperative venous blood was drawn to detect serum C-reactive protein

    Full Information

    First Posted
    June 6, 2023
    Last Updated
    June 30, 2023
    Sponsor
    Yangzhou University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05936918
    Brief Title
    Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy
    Official Title
    Effects of Transcutaneous Electrical Acupoint Stimulation Combined With Transverse Abdominis Plane Block on Perioperative Pain and Early Postoperative Recovery in Patients Undergoing Laparoscopic Cholecystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yangzhou University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To explore the application of transcutaneous electrical acupoint stimulation combined with transverse abdominis plane block in Laparoscopic cholecystectomy, in order to reduce postoperative pain and promote postoperative recovery.
    Detailed Description
    Percutaneous electrical acupoint stimulation has been applied in preoperative prophylaxis, intraoperative anesthesia and postoperative rehabilitation, and can reduce perioperative anxiety, improve the efficacy of preoperative smoking cessation and alcohol abstinence, and shorten the preoperative fasting time. During surgery, it can reduce the amount of anesthetic drugs, anti-inflammatory and anti-stress effects, stabilize circulation, and protect important organs; After surgery, improve the speed and quality of wake-up of patients, promote the recovery of maintenance function, regulate immune function, and reduce postoperative adverse reactions such as postoperative pain, postoperative nausea and vomiting, postoperative urinary retention, etc. As one of the common nerve blocks, transverse abdominis block is used clinically, and its main function is to relieve perioperative pain and reduce the amount of traumatic stress and analgesic drugs

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain Postoperative, Postoperative Recovery
    Keywords
    Transcutaneous electrical acupoint stimulation, Postoperative pain, Visceral pain, Early recovery after surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study was primarily a randomized controlled study in which patients were randomly assigned to each group.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Data collector
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TT group
    Arm Type
    Experimental
    Arm Description
    Bilateral Neiguan acupuncture points (PC6), Hegu acupuncture points (LI4), Zusanli (ST36) were selected, and percutaneous acupuncture points were electrically stimulated with electronic acupuncture equipment 30min before anesthesia, and then bilateral abdominal transverse plane blockade was performed
    Arm Title
    TE group
    Arm Type
    Active Comparator
    Arm Description
    Bilateral Neiguan acupuncture points (PC6), Hegu acupuncture points (LI4), Zusanli (ST36) were selected, and percutaneous acupuncture points were electrically stimulated with electronic acupuncture equipment 30min before anesthesia
    Arm Title
    TA group
    Arm Type
    Active Comparator
    Arm Description
    Bilateral transverse abdominal plane block is performed prior to anesthesia
    Arm Title
    C group
    Arm Type
    No Intervention
    Arm Description
    Percutaneous electrical stimulation of acupoints and transverse abdominis plane block are not permitted before anesthesia
    Intervention Type
    Other
    Intervention Name(s)
    Transcutaneous electrical acupoint stimulatios
    Intervention Description
    Percutaneous electrical stimulation technology of acupuncture points is a technology that uses a trace current close to human bioelectricity on the surface of acupuncture points to prevent and treat diseases guided by meridian theory, and is a new treatment of percutaneous nerve electrical stimulation combined with acupuncture points. As one of the related techniques of acupuncture, it is a safe, non-invasive, simple and new acupoint stimulation method
    Intervention Type
    Other
    Intervention Name(s)
    Bilateral transverse abdominal plane block
    Intervention Description
    Transverse abdominis plane block is a technique in which a local anesthetic is injected into the transverse abdominis plane to block sensory nerves passing through this plane to achieve analgesic effect
    Primary Outcome Measure Information:
    Title
    VAS(visual analogue scale) score
    Description
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    Time Frame
    The day before surgery
    Title
    VAS(visual analogue scale) score
    Description
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    Time Frame
    After the operation 30minute
    Title
    VAS(visual analogue scale) score
    Description
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    Time Frame
    After the operation 6hour
    Title
    VAS(visual analogue scale) score
    Description
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    Time Frame
    After the operation 12hour
    Title
    VAS(visual analogue scale) score
    Description
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    Time Frame
    After the operation 24hour
    Title
    VAS(visual analogue scale) score
    Description
    Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
    Time Frame
    After the operation 48hour
    Secondary Outcome Measure Information:
    Title
    Postoperative nausea and vomiting
    Description
    After surgery, patients are asked about nausea and vomiting. Postoperative nausea and vomiting is assessed after surgery by using visual analogue scoring. Using a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no nausea and vomiting, and 10 points represent the most severe nausea and vomiting that is unbearable.
    Time Frame
    The day before surgery; After the operation 24hours, 48hours
    Title
    Early postoperative recovery of quality
    Description
    The quality of early postoperative recovery was assessed using The Quality of Recovery-15 scale after surgery, scores range from 0 (QoR very poor) to 150 (QoR excellent), with higher scores representing better quality of recovery
    Time Frame
    The day before surgery; After the operation 24hours, 48hours
    Title
    Exhaust and bowel movements
    Description
    Record the time of the patient's first exhaust bowel movement after surgery
    Time Frame
    After the operation 24hours, 48hours
    Title
    Concentration of serum interleukin-6
    Description
    Perioperative venous blood was drawn to detect serum interleukin-6
    Time Frame
    the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery
    Title
    Concentration of serum cortisol
    Description
    Perioperative venous blood was drawn to detect serum cortisol
    Time Frame
    the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery
    Title
    Concentration of serum C-reactive protein
    Description
    Perioperative venous blood was drawn to detect serum C-reactive protein
    Time Frame
    the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) class I and II Age 18-65 years Laparoscopic cholecystectomy for the first time There is no rupture, infection in the acupoint pasting site The patient knows and signs the informed consent form Exclusion Criteria: People with visual impairment, hearing impairment and alcoholism History of diabetes, myocardial infarction or cerebrovascular accident, liver and kidney dysfunction Those who are allergic to non-steroidal drugs, anticholinergic drugs, and anesthetic drugs Those who are unable to cooperate or refuse to participate in the research or request to withdraw during the research process Those with contraindications to percutaneous electrical stimulation, including local skin damage, infection or implantation of electrophysiological devices in the body

    12. IPD Sharing Statement

    Learn more about this trial

    Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy

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