Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy
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: TEAS group, sham group.
- Who it may be relevant to
- Registry conditions: Liver 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Transcutaneous Electrical Acupoint Stimulation on Chronic Pain and Survival in Patients Undergoing Hepatectomy: a Prospective, Randomized Controlled Trial
Overview
This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain, quality of life and survival rate in patients undergoing hepatectomy.
Detailed description
This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain and survival in patients undergoing hepatectomy. 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 30 min 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. Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival, overall survival at 3 months and 6 months postoperatively.
Interventions
- Device TEAS group
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 30 min before anesthesia until be discharged from the post-anaesthesia 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 tolera - Device sham group
Patients in the sham group will receive electrode attachment but without stimulation.
Primary outcome measures
- The incidence of chronic pain at 3 months postoperatively [Time frame: 3 months postoperatively]
Secondary outcome measures (9)
- The incidence of chronic pain at 6 months [Time frame: 6 months postoperatively]
- Overall survival postoperatively [Time frame: Up to 6 months postoperatively]
- Recurrence-free survival postoperatively [Time frame: Up to 6 months postoperatively]
- Disability-free survival postoperatively [Time frame: Up to 6 months postoperatively]
- Quality of Recovery Scale Score postoperatively [Time frame: Up to 6 months postoperatively]
- The sleep quality score postoperatively [Time frame: Up to 6 months postoperatively]
- The anxiety and depression scores postoperatively [Time frame: Up to 6 months postoperatively]
- The prevalence of neuropathic pain [Time frame: Up to 6 months postoperatively]
- Brief Pain Inventory(BPI) pain interference subscale score [Time frame: Up to 6 months postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital — Chengdu
Identifiers
NCT: NCT06406244 · 2024HX1564-2