Clinical trial NCT06406244: Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy
Official title: Efficacy of Transcutaneous Electrical Acupoint Stimulation on Chronic Pain and Survival in Patients Undergoing Hepatectomy: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS group) or the sham groups using a computer-generated random number table.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: The incidence of chronic pain at 3 months postoperatively
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: The incidence of chronic pain at 6 months
timeFrame: 6 months postoperatively
measure: Overall survival postoperatively
timeFrame: Up to 6 months postoperatively
measure: Recurrence-free survival postoperatively
timeFrame: Up to 6 months postoperatively
measure: Disability-free survival postoperatively
timeFrame: Up to 6 months postoperatively
measure: Quality of Recovery Scale Score postoperatively
timeFrame: Up to 6 months postoperatively
measure: The sleep quality score postoperatively
timeFrame: Up to 6 months postoperatively
measure: The anxiety and depression scores postoperatively
timeFrame: Up to 6 months postoperatively
measure: The prevalence of neuropathic pain
timeFrame: Up to 6 months postoperatively
measure: Brief Pain Inventory(BPI) pain interference subscale score
timeFrame: Up to 6 months postoperatively
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
Study officials:
affiliation: West China Hospital
name: Chunling Jiang, PhD
role: STUDY_DIRECTOR
References: