Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy

Postoperative Recovery Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05936918
• Other study ID #: 2023-YKL04- (ke04)
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Postoperative
• Pain, Postoperative
• Postoperative Recovery

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The day before surgery
Primary	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.	After the operation 30minute
Primary	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.	After the operation 6hour
Primary	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.	After the operation 12hour
Primary	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.	After the operation 24hour
Primary	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.	After the operation 48hour
Secondary	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.	The day before surgery; After the operation 24hours, 48hours
Secondary	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	The day before surgery; After the operation 24hours, 48hours
Secondary	Exhaust and bowel movements	Record the time of the patient's first exhaust bowel movement after surgery	After the operation 24hours, 48hours
Secondary	Concentration of serum interleukin-6	Perioperative venous blood was drawn to detect serum interleukin-6	the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery
Secondary	Concentration of serum cortisol	Perioperative venous blood was drawn to detect serum cortisol	the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery
Secondary	Concentration of serum C-reactive protein	Perioperative venous blood was drawn to detect serum C-reactive protein	the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery