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2025-07-16
2026-09-02
2026-09-30
132
NCT06541561
West China Hospital
West China Hospital
INTERVENTIONAL
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy
The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing pancreatectomy
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), Zusanli (ST 36), Hegu (L14) and Waiguan (SJ5) acupoints. The treatment will consist of two phases: a 30-minute stimulation administered 30 minutes before anesthesia induction, and a 30-minute stimulation session once daily on postoperative days 1, 2, and 3. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-08-02 | N/A | 2025-07-14 |
2024-08-02 | N/A | 2025-07-17 |
2024-08-07 | N/A | 2024-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: TEAS group In the TEAS group, the acupoints are bilateral neiguan (PC6), Zusanli (ST 36), Hegu (L14) and Waiguan (SJ5) acupoints. The treatment will consist of two phases: a 30-minute stimulation administered 30 minutes before anesthesia induction, and a 30-minute s | DEVICE: transcutaneous electrical acupoint stimulation
|
| SHAM_COMPARATOR: sham group Patients in the sham group will receive electrode attachment but without stimulation. | DEVICE: sham transcutaneous electrical acupoint stimulation
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| highest NRS pain score for movement-evoked pain (defined as deep breathing or forced coughing three times) during 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. | Up to 72 hours postoperatively |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| the highest NRS pain score at rest during 72 h 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. | 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 | 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. | 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, during hospitalization after surgery. | Up to 7 days postoperatively |
| 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). | Up to 3 days postoperatively |
| 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 | Up to 3 days postoperatively |
| The plasma levels of C-reactive protein (CRP), procalcitonin (PCT), beta-endorphin, serotonin (5-HT), interleukin-2 (IL-2), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) on the 1st, 3rd, and 5th postoperative days | Peripheral blood C-reactive protein (CRP), procalcitonin (PCT), beta-endorphin, serotonin (5-HT), interleukin-2 (IL-2), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) are measured at the 1st, 3rd, and 5th postoperative | Up to 5 days postoperatively] |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Chunling Jiang, PhD Phone Number: 18980601096 Email: jiangchunling@scu.edu.cn |
Study Contact Backup Name: Luo Fengming, PhD Phone Number: 85423593 Email: jiangchunling@scu.edu.cn |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
