Liver CancerNCT06341270
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy
A study testing transcutaneous electrical acupoint stimulation in people with Liver Cancer, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.
Who cannot join
- Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Chunling Jiang, PhD, 18980601096, jiang_chunling@yahoo.com
About this study
Official title: Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy：a Prospective, Randomized Controlled Trial
The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy
Read the detailed description
Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS#or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive TEAS 30min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.
Patients in the sham group will receive electrode attachment but without stimulation.
- Conditions
- Liver Cancer
- Being tested
- transcutaneous electrical acupoint stimulation, sham transcutaneous electrical acupoint stimulation
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationDevice
transcutaneous electrical acupoint stimulation Transcutaneous electrical acupoint stimulation (TEAS) is a contemporary modification of traditional acupuncture that sends electrical impulses into acupoints through electrodes on the skin surface. In the TEAS group, patients will receive TEAS 30min before anesthesia until be discharged from the postanaesthesia care unit (PACU). The same treatment will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.
sham transcutaneous electrical acupoint stimulationDevice
Patients in the sham group will receive electrode attachment but without stimulation.
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS#or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive 30min TEAS before anesthesia until be discharged from the post anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. Receives: Device: transcutaneous electrical acupoint stimulation |
| sham group | Sham comparator | Patients in the sham group will receive electrode attachment but without stimulation. Receives: Device: sham transcutaneous electrical acupoint stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery
The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
Measured: Up to 24 hours postoperatively
Secondary outcomes (13)
The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 48 and 72 hours after surgery
The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
Measured: Up to 72 hours postoperatively
The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery
The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
Measured: Up to 72 hours postoperatively
Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours
The pain is evaluated using numerical rating scale,NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain.
Measured: Up to 72 hours postoperatively
Pain scores of pain at rest at 24, 48 and 72 hours postoperatively
The pain is evaluated using numerical rating scale,NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain
Measured: Up to 72 hours postoperatively
The cumulative morphine consumption at 24, 48, and 72 hours postoperatively
Postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator
Measured: Up to 72 hours postoperatively
The incidence of postoperative nausea and vomiting during the first 24,48,72 hours
We considered it PONV if patients felt any nausea or had any vomiting
Measured: Up to 72 hours postoperatively
The incidence of a composite of postoperative pulmonary complications during hospitalization
Defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis loading dose, immediately after the end of surgery, and at the first 24 hours after surgery
Measured: immediately after the end of surgery, and at the first 24 hours after surgery
Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery
The global QoR-15 score ranges from 0 to 150 and is categorized as five quality of recovery dimensions, including physical comfort (5 items), emotional state (4 items), psychological support (2 items), physical independence (2 items), and pain (2 items). Each piece is graded using an 11-point Likert scale. The QoR is classified according to the QoR-15 score as excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) and poor (QoR-15 < 90)
Measured: Up to 72 hours postoperatively
Time of Bowel function recovery
Defined as the time to first defecation or time to first flatusdefined as the time to first defecation or time to first flatus defined as the time to first defecation or time to first flatus
Measured: Up to 72 hours postoperatively
Length of hospital stay
Determined by the number of days from admittance to discharge
Measured: From admittance to discharge
The postoperative sleep quality score
Postoperative sleep quality was evaluated using the Athens Insomnia Scale (AIS). The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness. The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.
Measured: Up to 72 hours postoperatively
The anxiety and depression scores
Anxiety and depression score will be evaluated using the Hospital Anxiety and Depression Scale (HADS).The HADS consists of 14 questions, with 7 items each for the anxiety and depression subscales. The score for each item ranges from 0 to 3 points, and scores are summed to yield a separate score for anxiety (HADS-A) and depression (HADS-D).
Measured: Up to 72 hours postoperatively
The incidence of chronic postsurgical pain (CPSP)
Patients were inquired whether they had any pain （NRS ≥ 1）in surgical area and if the pain developed postoperatively. If subjects answered with a 'no' to any of the two questions, those patients were classified as cases without CPSP. Contrarily, if subjects answered yes, they were considered CPSP cases.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start6 May 2024
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Model description
- Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups using a computer-generated random number table. After the randomization, use the opaque envelope, hide each group envelope into an opaque envelope, the envelope outside the code, will be sealed to the researcher, when the study, if the inclusion criteria, then open the corresponding numbered envelope, and intervene according to the group scheme in the envelope.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Chunling Jiang, PhD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341270
- Sponsor's protocol ID
- 2024HX1564
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy：a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06341270
- Acronym / sponsor ID
- 2024HX1564
- Conditions
- Liver Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 2 Apr 2024 (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 purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy
Detailed description
Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS#or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive TEAS 30min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.
Patients in the sham group will receive electrode attachment but without stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups using a computer-generated random number table. After the randomization, use the opaque envelope, hide each group envelope into an opaque envelope, the envelope outside the code, will be sealed to the researcher, when the study, if the inclusion criteria, then open the corresponding numbered envelope, and intervene according to the group scheme in the envelope.
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: transcutaneous electrical acupoint stimulationPatients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS#or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive 30min TEAS before anesthesia until be discharged from the post anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. |
| sham group | Sham comparator | Device: sham transcutaneous electrical acupoint stimulationPatients in the sham group will receive electrode attachment but without stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.
Key exclusion criteria (1 listed)
- Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs;
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 stimulationtranscutaneous electrical acupoint stimulation Transcutaneous electrical acupoint stimulation (TEAS) is a contemporary modification of traditional acupuncture that sends electrical impulses into acupoints through electrodes on the skin surface. In the TEAS group, patients will receive TEAS 30min before anesthesia until be discharged from the postanaesthesia care unit (PACU). The same treatment will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. | Device | TEAS group |
| sham transcutaneous electrical acupoint stimulationPatients in the sham group will receive electrode attachment but without stimulation. | Device | sham group |
Primary outcome
The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery
Time frame: Up to 24 hours postoperatively
The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
13 secondary outcomes
The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 48 and 72 hours after surgery
Time frame: Up to 72 hours postoperatively
The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery
Time frame: Up to 72 hours postoperatively
Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours
Time frame: Up to 72 hours postoperatively
Pain scores of pain at rest at 24, 48 and 72 hours postoperatively
Time frame: Up to 72 hours postoperatively
The cumulative morphine consumption at 24, 48, and 72 hours postoperatively
Time frame: Up to 72 hours postoperatively
The incidence of postoperative nausea and vomiting during the first 24,48,72 hours
Time frame: Up to 72 hours postoperatively
The incidence of a composite of postoperative pulmonary complications during hospitalization
Time frame: immediately after the end of surgery, and at the first 24 hours after surgery
Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery
Time frame: Up to 72 hours postoperatively
Time of Bowel function recovery
Time frame: Up to 72 hours postoperatively
Length of hospital stay
Time frame: From admittance to discharge
The postoperative sleep quality score
Time frame: Up to 72 hours postoperatively
The anxiety and depression scores
Time frame: Up to 72 hours postoperatively
The incidence of chronic postsurgical pain (CPSP)
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Chunling Jiang, PhD study director
West China Hospital
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 Liver Cancer, run by West China Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunling Jiang, PhD (18980601096, jiang_chunling@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery (time frame: Up to 24 hours postoperatively). 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 15 Jul 2024.