Pain PostoperativeNCT05936918

Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy

A study testing Transcutaneous electrical acupoint stimulatios and Bilateral transverse abdominal plane block in people with Pain Postoperative and Postoperative Recovery, run by Yangzhou University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pain Postoperative, Postoperative Recovery
What is being tested?: Transcutaneous electrical acupoint stimulatios and Bilateral transverse abdominal plane block
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: No sites listed yet
Study dates: 2 Jul 2023to 31 Dec 2023
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

Read the 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
Being tested: Transcutaneous electrical acupoint stimulatios, Bilateral transverse abdominal plane block
Keywords: Transcutaneous electrical acupoint stimulation, Postoperative pain, Visceral pain, Early recovery after surgery
Medical subject headings: Pain, Postoperative, Visceral Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous electrical acupoint stimulatiosOther
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 blockOther
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

Study groups in NCT05936918
Study group	Role	What they receive
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 Receives: 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 Receives: Other: Transcutaneous electrical acupoint stimulatios
TA group	Active comparator	Bilateral transverse abdominal plane block is performed prior to anesthesia Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the operation 48hour

Secondary outcomes (6)

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.
Measured: The day before surgery; After the operation 24hours, 48hours
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
Measured: The day before surgery; After the operation 24hours, 48hours
Exhaust and bowel movements
Record the time of the patient's first exhaust bowel movement after surgery
Measured: After the operation 24hours, 48hours
Concentration of serum interleukin-6
Perioperative venous blood was drawn to detect serum interleukin-6
Measured: 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
Perioperative venous blood was drawn to detect serum cortisol
Measured: 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 C-reactive protein
Perioperative venous blood was drawn to detect serum C-reactive protein
Measured: the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 202331 Dec 2023

First posted10 Jul 2023
Study start2 Jul 2023 (estimated)
Primary completion31 Oct 2023 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study was primarily a randomized controlled study in which patients were randomly assigned to each group.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05936918
Sponsor's protocol ID: 2023-YKL04- (ke04)
Status last verified: Jun 2023
First submitted: 6 Jun 2023
Last updated: 10 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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