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NCT Number: NCT06541561

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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；

Treatment and study plan

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.

Sham Transcutaneous Electrical Acupoint Stimulation

Device

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. the highest NRS pain score at rest during 72 h postoperatively

    Time frame: Up to 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.

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

    Time frame: Up to 72 hours postoperatively

    Postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator

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

    Time frame: Up to 72 hours postoperatively

    We considered it PONV if patients felt any nausea or had any vomiting.

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

    Time frame: Up to 7 days postoperatively

    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.

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

    Time frame: Up to 3 days postoperatively

    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).

  6. The postoperative sleep quality score

    Time frame: Up to 3 days postoperatively

    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

  7. 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]

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Chunling Jiang, PhD

CONTACT

[email protected]

18980601096

Luo Fengming, PhD

CONTACT

[email protected]

85423593

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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