Transcutaneous Electrical Acupoint StimulationNCT06024200
Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery
A study testing transcutaneous electrical acupoint stimulation in people with Transcutaneous Electrical Acupoint Stimulation, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effect of whole-process transcutaneous electrical acupoint stimulation on opioid consumption after gastrointestinal laparoscopic surgery. All subjects received conventional multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcutaneous Electrical Acupoint Stimulation
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2023to 30 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or older;
- scheduled for elective laparoscopic gastrointestinal surgery；
- informed consent；
- American Society of Anesthesiologists Physical Status Grades I-III；
- body mass index (BMI) between 18.5 kg/m2 and 28 kg/m2
Who cannot join
- local skin infection, incision or scar near the study acupoints;
- nerve damage in upper or lower limbs;
- participation in other clinical trials that influence the evaluation of the results of this study;
- inability to understand the Visual Analog Scale (VAS) score or disagreeing with the use of patient controlled analgesia;
- presence of a pacemaker;
- patients with severe CNS diseases or severe mental disorders;
- operations requiring enterostomy or converts to laparotomy;
- patients who need to be transferred to the intensive care unit (ICU) for treatment after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515
Guoxin Li, M.D.,Ph.D., +8613802771450, gzliguoxin@163.com
About this study
Official title: Effect of Whole-process Transcutaneous Electrical Acupoint Stimulation on Opioid Consumption After Gastrointestinal Laparoscopic Surgery: a Prospective, Randomised, Blinded, Placebo-controlled Study
The goal of this clinical trial is to evaluate the effect of whole-process transcutaneous electrical acupoint stimulation on opioid consumption after gastrointestinal laparoscopic surgery. All subjects received conventional multimodal analgesia. On this basis, the experimental group received whole-process transcutaneous electrical acupoint stimulation, while the control group received corresponding false stimulation.
Read the detailed description
Conventional multimodal analgesia protocols as follows：
- Before the end of the operation, the surgical incision was infiltrated with 0.5% ropivacaine 10 mL locally.
- Patients were transferred to the PACU and provided with patient-controlled intravenous analgesia with sufentanil for postoperative analgesia. The analgesia devices were set to a concentration of 1ug/mL, with a lockout interval of 15 minutes, and a 3 mL bolus，without an infusion dose. The pump was withdrawn 72h after surgery.
- Flurbiprofen: 50mg per dose intravenously twice a day for postoperative three days.
- Being tested
- transcutaneous electrical acupoint stimulation, transcutaneous electrical acupoint stimulation sham stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationOther
Electrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient.
transcutaneous electrical acupoint stimulation sham stimulationOther
Patients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| whole-process transcutaneous electrical acupoint stimulation | Experimental | Electrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient. Receives: Other: transcutaneous electrical acupoint stimulation |
| whole-process transcutaneous electrical acupoint stimulation(sham stimulation) | Sham comparator | Patients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group. Receives: Other: transcutaneous electrical acupoint stimulation sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total sufentanil consumption postoperatively
measured from the recovery area until postoperative day 3
Measured: 3 days
Secondary outcomes (14)
The number of postoperative rescue analgesia
measured from the recovery area until discharge
Measured: 7 days
Pain scores (VAS)
measured by Visual Analogue Scale( VAS ), which is a scale created in the range of 0 to 10 cm. According to the scale, 0 cm means no pain, and 10 cm means unbearable pain. On the scale, 1 to 3 cm indicates mild pain, 4 to 6 cm indicates moderate pain, and 7 to 10 cm indicates severe pain.
Measured: 4 days
Pain Catastrophizing
measured by Pain Catastrophizing Scale（PCS）, which contains 13 items in three dimensions: rumination, magnification, and helplessness. Patients can answer on a 0-to-4 likert scale (0 = "not at all" and 4 = "all the time"). PCS scores range from 0 to 52, and the higher the score,the higher the frequency of catastrophizing cognitions.
Measured: 5 days
Quality of recovery
measured by Quality of Recovery (QoR)-15 questionnaire, which consists of 15 questions distributed on two dimensions: "physical" and "mental" well-being. The patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time), where negatively loaded questions are reversed. This gives a maximum score = 150.
Measured: 5 days
The variation of C-reactive protein（CRP）
the values of C-reactive protein from peripheral blood
Measured: 3 days
Procalcitonin（PCT）
the values of procalcitonin from peripheral blood
Measured: 3 days
The variation of white blood cell count （WBC）
the values of white blood cell count from peripheral blood
Measured: 3 days
Neutrophil ratio（NEUT）
neutrophil ratio from peripheral blood
Measured: 3 days
Time to first ambulation
time to first ambulation in hours is used
Measured: up to 7 days
Time to first flatus
time to first flatus in hours is used
Measured: up to 7 days
Time to first defecation
time to first defecation in hours is used
Measured: 7 days
Time to first feed
time to first feed in hours is used
Measured: up to 7 days
The incidence rate of adverse reaction
adverse reaction includes PONV、abdominal distension、 diarrhea、difficult defecation ect.
Measured: 7 days
Satisfaction score with pain management
measured by 5-point Likert scale, "1" represents very dissatisfied while "5" represents very satisfied
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start2 Jun 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Acupoint StimulationStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoxin Li, M.D.,Ph.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024200
- Sponsor's protocol ID
- NFEC-2023-327
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-process Transcutaneous Electrical Acupoint Stimulation on Opioid Consumption After Gastrointestinal Laparoscopic Surgery: a Prospective, Randomised, Blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06024200
- Acronym / sponsor ID
- NFEC-2023-327
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 6 Sep 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.
The goal of this clinical trial is to evaluate the effect of whole-process transcutaneous electrical acupoint stimulation on opioid consumption after gastrointestinal laparoscopic surgery. All subjects received conventional multimodal analgesia. On this basis, the experimental group received whole-process transcutaneous electrical acupoint stimulation, while the control group received corresponding false stimulation.
Detailed description
Conventional multimodal analgesia protocols as follows：
- Before the end of the operation, the surgical incision was infiltrated with 0.5% ropivacaine 10 mL locally.
- Patients were transferred to the PACU and provided with patient-controlled intravenous analgesia with sufentanil for postoperative analgesia. The analgesia devices were set to a concentration of 1ug/mL, with a lockout interval of 15 minutes, and a 3 mL bolus，without an infusion dose. The pump was withdrawn 72h after surgery.
- Flurbiprofen: 50mg per dose intravenously twice a day for postoperative three days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole-process transcutaneous electrical acupoint stimulation | Experimental | Other: transcutaneous electrical acupoint stimulationElectrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient. |
| whole-process transcutaneous electrical acupoint stimulation(sham stimulation) | Sham comparator | Other: transcutaneous electrical acupoint stimulation sham stimulationPatients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 years or older;
- scheduled for elective laparoscopic gastrointestinal surgery；
- informed consent；
- American Society of Anesthesiologists Physical Status Grades I-III；
- body mass index (BMI) between 18.5 kg/m2 and 28 kg/m2
Key exclusion criteria (8 listed)
- local skin infection, incision or scar near the study acupoints;
- nerve damage in upper or lower limbs;
- participation in other clinical trials that influence the evaluation of the results of this study;
- inability to understand the Visual Analog Scale (VAS) score or disagreeing with the use of patient controlled analgesia;
- presence of a pacemaker;
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 stimulationElectrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient. | Other | whole-process transcutaneous electrical acupoint stimulation |
| transcutaneous electrical acupoint stimulation sham stimulationPatients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group. | Other | whole-process transcutaneous electrical acupoint stimulation(sham stimulation) |
Primary outcome
The total sufentanil consumption postoperatively
Time frame: 3 days
measured from the recovery area until postoperative day 3
14 secondary outcomes
The number of postoperative rescue analgesia
Time frame: 7 days
Pain scores (VAS)
Time frame: 4 days
Pain Catastrophizing
Time frame: 5 days
Quality of recovery
Time frame: 5 days
The variation of C-reactive protein（CRP）
Time frame: 3 days
Procalcitonin（PCT）
Time frame: 3 days
The variation of white blood cell count （WBC）
Time frame: 3 days
Neutrophil ratio（NEUT）
Time frame: 3 days
Time to first ambulation
Time frame: up to 7 days
Time to first flatus
Time frame: up to 7 days
Time to first defecation
Time frame: 7 days
Time to first feed
Time frame: up to 7 days
The incidence rate of adverse reaction
Time frame: 7 days
Satisfaction score with pain management
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 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.
Guoxin Li, M.D.,Ph.D. principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation in people with Transcutaneous Electrical Acupoint Stimulation, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 8 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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Guoxin Li, M.D.,Ph.D. (+86 13802771450, gzliguoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total sufentanil consumption postoperatively (time frame: 3 days). 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 11 Sep 2023.