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

NCT06541561 | Not Yet Recruiting

• 1 other identifier: 2024HX0803
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• the highest NRS pain score at rest during 72 h postoperatively

  Up to 72 hours postoperatively

• The cumulative morphine consumption at 24, 48, and 72 hours postoperatively.

  Up to 72 hours postoperatively

• The incidence of postoperative nausea and vomiting during the first 24,48,72 hours.

  Up to 72 hours postoperatively

• The incidence of a composite of postoperative pulmonary complications during hospitalization.

  Up to 7 days postoperatively

• Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery.

  Up to 3 days postoperatively

Study Arms (2)

TEAS group

EXPERIMENTAL

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.

Device: transcutaneous electrical acupoint stimulation

sham group

SHAM COMPARATOR

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

Device: sham transcutaneous electrical acupoint stimulation

Interventions

transcutaneous electrical acupoint stimulation 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.

TEAS group

sham transcutaneous electrical acupoint stimulation DEVICE

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

sham group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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；

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (1)

• 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. doi: 10.1186/s13063-025-09386-5. Online ahead of print.

  PMID: 41469720 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Luo Fengming, PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiangchunling@scu.edu.cn

Luo Fengming, PhD

CONTACT

85423593; jiangchunling@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: July 16, 2025
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 17, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share