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NCT Number: NCT06341270

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

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

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Chunling Jiang, PhD

CONTACT

[email protected]

18980601096

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) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive TEAS 30min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.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 classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.

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;

Treatment and study plan

Transcutaneous electrical acupoint stimulation

Device

transcutaneous electrical acupoint stimulation Transcutaneous electrical acupoint stimulation (TEAS) is a contemporary modification of traditional acupuncture that sends electrical impulses into acupoints through electrodes on the skin surface. In the TEAS group, patients will receive TEAS 30min before anesthesia until be discharged from the postanaesthesia care unit (PACU). The same treatment will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.

Sham Transcutaneous Electrical Acupoint Stimulation

Device

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

Primary outcomes

  1. The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery

    Time frame: Up to 24 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, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.

Secondary outcomes

  1. The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 48 and 72 hours after surgery

    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, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.

  2. The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery

    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, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.

  3. Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours

    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.

  4. Pain scores of pain at rest at 24, 48 and 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

  5. 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

  6. 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

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

    Time frame: immediately after the end of surgery, and at the first 24 hours after surgery

    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, immediately after the end of surgery, and at the first 24 hours after surgery

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

    Time frame: Up to 72 hours 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)

  9. Time of Bowel function recovery

    Time frame: Up to 72 hours postoperatively

    Defined as the time to first defecation or time to first flatusdefined as the time to first defecation or time to first flatus defined as the time to first defecation or time to first flatus

  10. Length of hospital stay

    Time frame: From admittance to discharge

    Determined by the number of days from admittance to discharge

  11. The postoperative sleep quality score

    Time frame: Up to 72 hours 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.

  12. The anxiety and depression scores

    Time frame: Up to 72 hours postoperatively

    Anxiety and depression score will be evaluated using the Hospital Anxiety and Depression Scale (HADS).The HADS consists of 14 questions, with 7 items each for the anxiety and depression subscales. The score for each item ranges from 0 to 3 points, and scores are summed to yield a separate score for anxiety (HADS-A) and depression (HADS-D).

  13. The incidence of chronic postsurgical pain (CPSP)

    Time frame: 3 months after surgery

    Patients were inquired whether they had any pain （NRS ≥ 1）in surgical area and if the pain developed postoperatively. If subjects answered with a 'no' to any of the two questions, those patients were classified as cases without CPSP. Contrarily, if subjects answered yes, they were considered CPSP cases.

Study contacts

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

Chunling Jiang, PhD

CONTACT

[email protected]

18980601096

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 Hepatectomy：a Prospective, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2024
Registry last updated
Jul 15, 2024

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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