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.
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
- Are there results?
- None posted in the registry
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang wanxia, Yangzhou University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05936918
- Acronym / sponsor ID
- 2023-YKL04- (ke04)
- Conditions
- Pain Postoperative, Postoperative Recovery
- Keywords
- Transcutaneous electrical acupoint stimulation, Postoperative pain, Visceral pain, Early recovery after surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 2 Jul 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- The study was primarily a randomized controlled study in which patients were randomly assigned to each group.
| Arm | Type | Receives |
|---|---|---|
| TT group | Experimental | Other: Transcutaneous electrical acupoint stimulatios, Other: Bilateral transverse abdominal plane blockBilateral 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 |
| TE group | Active comparator | Other: Transcutaneous electrical acupoint stimulatiosBilateral 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 |
| TA group | Active comparator | Other: Bilateral transverse abdominal plane blockBilateral transverse abdominal plane block is performed prior to anesthesia |
| C group | No intervention | –Percutaneous electrical stimulation of acupoints and transverse abdominis plane block are not permitted before anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical acupoint stimulatiosPercutaneous 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 | Other | TE group, TT group |
| Bilateral transverse abdominal plane blockTransverse 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 | Other | TA group, TT group |
Primary outcome
VAS(visual analogue scale) score
Time frame: The day before surgery
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
Time frame: After the operation 30minute
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
Time frame: After the operation 6hour
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
Time frame: After the operation 12hour
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
Time frame: After the operation 24hour
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
Time frame: After the operation 48hour
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.
6 secondary outcomes
Postoperative nausea and vomiting
Time frame: The day before surgery; After the operation 24hours, 48hours
Early postoperative recovery of quality
Time frame: The day before surgery; After the operation 24hours, 48hours
Exhaust and bowel movements
Time frame: After the operation 24hours, 48hours
Concentration of 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
Concentration of 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
Concentration of 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS(visual analogue scale) score (time frame: The day before surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.