Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy

NCT05936918 | Unknown

• 1 other identifier: 2023-YKL04- (ke04)
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain Postoperative; Postoperative Recovery

Keywords

Transcutaneous electrical acupoint stimulation; Postoperative pain; Visceral pain; Early recovery after surgery

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Postoperative nausea and vomiting

  The day before surgery; After the operation 24hours, 48hours

• Early postoperative recovery of quality

  The day before surgery; After the operation 24hours, 48hours

• Exhaust and bowel movements

  After the operation 24hours, 48hours

• Concentration of 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

• Concentration of serum cortisol

  the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery

Study Arms (4)

TT group

EXPERIMENTAL

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

Other: Transcutaneous electrical acupoint stimulatios; Other: Bilateral transverse abdominal plane block

TE group

ACTIVE COMPARATOR

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

Other: Transcutaneous electrical acupoint stimulatios

TA group

ACTIVE COMPARATOR

Bilateral transverse abdominal plane block is performed prior to anesthesia

Other: Bilateral transverse abdominal plane block

C group

NO INTERVENTION

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

Interventions

Transcutaneous electrical acupoint stimulatios 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

TE group; TT group

Bilateral transverse abdominal plane block 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

TA group; TT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

MeSH Terms

Conditions

Pain, Postoperative; Visceral Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nociceptive Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data collector
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study was primarily a randomized controlled study in which patients were randomly assigned to each group.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 10, 2023
• Study Start: July 2, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-06