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

NCT ID: NCT06541561

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Blinding of participants will be maintained throughout the observation period. The sham group will receive electrode attachment but without stimulation, Throughout the study, for adequate blinding, an opaque tape will be applied to the patient's skin above the electrodes, and the patient's target acupoints will be wrapped in a blanket. All patients will be informed that they might or might not feel a tingling sensation around the acupoints when the TEAS device is working. The patients should not be unblinded until the statistical analysis of the study data is completed.

Study Groups

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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 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.

Group Type EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type DEVICE

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 without stimulation.

sham group

Patients in the sham group will receive electrode attachment but without stimulation.

Group Type SHAM_COMPARATOR

sham transcutaneous electrical acupoint stimulation

Intervention Type DEVICE

Patients in the sham group will receive electrode attachment but without stimulation.

Interventions

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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 without stimulation.

Intervention Type DEVICE

sham transcutaneous electrical acupoint stimulation

Patients in the sham group will receive electrode attachment but without stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunling Jiang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luo Fengming, PhD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Central Contacts

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Chunling Jiang, PhD

Role: CONTACT

18980601096

Luo Fengming, PhD

Role: CONTACT

Other Identifiers

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2024HX0803

Identifier Type: -

Identifier Source: org_study_id

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