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Trial Title:
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy
NCT ID:
NCT06341270
Condition:
Liver Cancer
Conditions: Official terms:
Pain, Postoperative
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients who meet the enrollment criteria will be randomized 1:1 to either the
transcutaneous electrical acupoint stimulation (TEAS）or the sham groups using a
computer-generated random number table. After the randomization, use the opaque envelope,
hide each group envelope into an opaque envelope, the envelope outside the code, will be
sealed to the researcher, when the study, if the inclusion criteria, then open the
corresponding numbered envelope, and intervene according to the group scheme in the
envelope.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Blinding of participants will be maintained throughout the observation period. The sham
group will receive electrode attachment but without stimulation,Throughout the study, for
adequate blinding, an opaque tape will be applied to the patient's skin above the
electrodes, and the patient's target acupoints will be wrapped in a blanket. All patients
will be informed that they might or might not feel a tingling sensation around the
acupoints when the TEAS device is working. The patients should not be unblinded until the
statistical analysis of the study data is completed.
Intervention:
Intervention type:
Device
Intervention name:
transcutaneous electrical acupoint stimulation
Description:
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.
Arm group label:
TEAS group
Intervention type:
Device
Intervention name:
sham transcutaneous electrical acupoint stimulation
Description:
Patients in the sham group will receive electrode attachment but without stimulation.
Arm group label:
sham group
Summary:
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunling Jiang, PhD
Phone:
18980601096
Email:
jiang_chunling@yahoo.com
Start date:
May 6, 2024
Completion date:
December 20, 2026
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06341270
