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

NCT06341270 | Recruiting

• 1 other identifier: 2024HX1564
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cancer

Outcome Measures

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

  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.

  Up to 24 hours postoperatively

Secondary Outcomes (13)

• 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

  Up to 72 hours postoperatively

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

  Up to 72 hours postoperatively

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

  Up to 72 hours postoperatively

• Pain scores of pain at rest at 24, 48 and 72 hours postoperatively

  Up to 72 hours postoperatively

• The cumulative morphine consumption at 24, 48, and 72 hours postoperatively

  Up to 72 hours postoperatively

Study Arms (2)

TEAS group

EXPERIMENTAL

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 30min TEAS before anesthesia until be 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.

Device: transcutaneous electrical acupoint stimulation

sham group

SHAM COMPARATOR

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

Device: sham transcutaneous electrical acupoint stimulation

Interventions

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.

TEAS group

sham transcutaneous electrical acupoint stimulation DEVICE

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

sham group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.

You may not qualify if:

• 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;

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Chunling Jiang, PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiang_chunling@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: May 6, 2024
• Primary Completion: April 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)