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Not yet recruiting NCT06541561

Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy

No phase Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcutaneous electrical acupoint stimulation, sham transcutaneous electrical acupoint stimulation.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy: a Prospective, Randomized Controlled Trial

Overview

The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing pancreatectomy

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), 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.

Interventions

  • Device transcutaneous electrical acupoint stimulation
    Patients 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
  • Device sham transcutaneous electrical acupoint stimulation
    Patients in the sham group will receive electrode attachment but without stimulation.

Primary outcome measures

  • highest NRS pain score for movement-evoked pain (defined as deep breathing or forced coughing three times) during 72 hours postoperatively. [Time frame: Up to 72 hours postoperatively]
Secondary outcome measures (7)
  • the highest NRS pain score at rest during 72 h 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: Up to 7 days postoperatively]
  • Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery. [Time frame: Up to 3 days postoperatively]
  • The postoperative sleep quality score [Time frame: 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 [Time frame: Up to 5 days postoperatively]]

Eligibility criteria

Inclusion criteria

Age 18-80 years old; ASA physical status class I - III; Patients scheduled for pancreatectomy.

Exclusion criteria

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; Have a history of Transcutaneous Electrical Acupuncture Stimulation (TEAS) or electroacupuncture treatment in the past or recently；

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Wu J, Chen J, Tang Q, Zhou L. Efficacy of perioperative transcutaneous electrical acupoint stimulation on postoperative pain and recovery in patients undergoing pancreatectomy: a study protocol for a randomized controlled trial. Trials. 2025 Dec 31;27(1):96. doi: 10.1186/s13063-025-09386-5. PMID 41469720

Identifiers

NCT: NCT06541561 · 2024HX0803

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗