Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy

NCT ID: NCT05936918

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-02
• Study Completion Date: 2023-12-31

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

Conditions

Pain Postoperative; Postoperative Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

TT group

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

Group Type: EXPERIMENTAL

Transcutaneous electrical acupoint stimulatios

Intervention Type: OTHER

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

Bilateral transverse abdominal plane block

Intervention Type: OTHER

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

TE group

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

Group Type: ACTIVE_COMPARATOR

Transcutaneous electrical acupoint stimulatios

Intervention Type: OTHER

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

TA group

Bilateral transverse abdominal plane block is performed prior to anesthesia

Group Type: ACTIVE_COMPARATOR

Bilateral transverse abdominal plane block

Intervention Type: OTHER

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

C group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcutaneous electrical acupoint stimulatios

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

Bilateral transverse abdominal plane block

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Wang wanxia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2023-YKL04- (ke04)

Identifier Type: -

Identifier Source: org_study_id