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

Liver Cancer Clinical Trial

Official title:

Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy：a Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06341270
• Other study ID #: 2024HX1564
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: December 20, 2026

Study information

• Verified date: March 2024
• Source: West China Hospital
• Contact: Chunling Jiang, PhD
• Phone: 18980601096
• Email: jiang_chunling[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 524
• Est. completion date: December 20, 2026
• Est. primary completion date: April 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Age 18-80 years old; ASA physical status class?-?; 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;

Related Conditions & MeSH terms

• Liver Cancer
• Pain, Postoperative

Intervention

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 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 tolerated by each patient.
• sham transcutaneous electrical acupoint stimulation
Patients in the sham group will receive electrode attachment but without stimulation.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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 72 hours postoperatively
Secondary	The incidence of moderate to severe pain (NRS = 4) at rest at 24, 48 and 72 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 72 hours postoperatively
Secondary	Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours	The pain is evaluated using numerical rating scale,NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain.	Up to 72 hours postoperatively
Secondary	Pain scores of pain at rest at 24, 48 and 72 hours postoperatively	The pain is evaluated using numerical rating scale,NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain	Up to 72 hours postoperatively
Secondary	The cumulative morphine consumption at 24, 48, and 72 hours postoperatively	Postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator	Up to 72 hours postoperatively
Secondary	The incidence of postoperative nausea and vomiting during the first 24,48,72 hours	We considered it PONV if patients felt any nausea or had any vomiting	Up to 72 hours postoperatively
Secondary	The incidence of a composite of postoperative pulmonary complications during hospitalization	Defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis loading dose, immediately after the end of surgery, and at the first 24 hours after surgery	immediately after the end of surgery, and at the first 24 hours after surgery
Secondary	Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery	The global QoR-15 score ranges from 0 to 150 and is categorized as five quality of recovery dimensions, including physical comfort (5 items), emotional state (4 items), psychological support (2 items), physical independence (2 items), and pain (2 items). Each piece is graded using an 11-point Likert scale. The QoR is classified according to the QoR-15 score as excellent (QoR-15 > 135), good (122 = QoR-15 = 135), moderate (90 = QoR-15 = 121) and poor (QoR-15 < 90)	Up to 72 hours postoperatively
Secondary	Time of Bowel function recovery	Defined as the time to first defecation or time to first flatusdefined as the time to first defecation or time to first flatus defined as the time to first defecation or time to first flatus	Up to 72 hours postoperatively
Secondary	Length of hospital stay	Determined by the number of days from admittance to discharge	From admittance to discharge
Secondary	The postoperative sleep quality score	Postoperative sleep quality was evaluated using the Athens Insomnia Scale (AIS). The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness. The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.	Up to 72 hours postoperatively
Secondary	The anxiety and depression scores	Anxiety and depression score will be evaluated using the Hospital Anxiety and Depression Scale (HADS).The HADS consists of 14 questions, with 7 items each for the anxiety and depression subscales. The score for each item ranges from 0 to 3 points, and scores are summed to yield a separate score for anxiety (HADS-A) and depression (HADS-D).	Up to 72 hours postoperatively
Secondary	The incidence of chronic postsurgical pain (CPSP)	Patients were inquired whether they had any pain (NRS = 1)in surgical area and if the pain developed postoperatively. If subjects answered with a 'no' to any of the two questions, those patients were classified as cases without CPSP. Contrarily, if subjects answered yes, they were considered CPSP cases.	3 months after surgery