Efficacy of TEAS on Postoperative Pain and Recovery 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: transcutaneous electrical acupoint stimulation, sham transcutaneous electrical acupoint stimulation.
- 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 →
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Official title
Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy：a Prospective, Randomized Controlled Trial
Overview
The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy
Detailed description
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.
Interventions
- Device transcutaneous electrical acupoint stimulation
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 - Device sham transcutaneous electrical acupoint stimulation
Patients in the sham group will receive electrode attachment but without stimulation.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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 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]
- Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours [Time frame: Up to 72 hours postoperatively]
- Pain scores of pain at rest at 24, 48 and 72 hours postoperatively [Time frame: Up to 72 hours postoperatively]
- The cumulative morphine consumption at 24, 48, and 72 hours postoperatively [Time frame: Up to 72 hours postoperatively]
- The incidence of postoperative nausea and vomiting during the first 24,48,72 hours [Time frame: Up to 72 hours postoperatively]
- 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]
- Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery [Time frame: Up to 72 hours postoperatively]
- Time of Bowel function recovery [Time frame: Up to 72 hours postoperatively]
- Length of hospital stay [Time frame: From admittance to discharge]
- The postoperative sleep quality score [Time frame: Up to 72 hours postoperatively]
- The anxiety and depression scores [Time frame: Up to 72 hours 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: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital — Chengdu
Identifiers
NCT: NCT06341270 · 2024HX1564