Liver Cancer
Conditions
Brief 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.
Interventions
DEVICEtranscutaneous 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 in accordance with the maximal level tolerated by each patient.
Patients in the sham group will receive electrode attachment but without stimulation.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery | Up to 24 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, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery | Up to 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, 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. |
| Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours | Up to 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. |
| Pain scores of pain at rest at 24, 48 and 72 hours postoperatively | Up to 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 |
| The cumulative morphine consumption at 24, 48, and 72 hours postoperatively | Up to 72 hours postoperatively | Postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator |
| The incidence of postoperative nausea and vomiting during the first 24,48,72 hours | Up to 72 hours postoperatively | We considered it PONV if patients felt any nausea or had any vomiting |
| The incidence of a composite of postoperative pulmonary complications during hospitalization | immediately after the end of surgery, and at the first 24 hours after surgery | 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 |
| 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 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. |
| Time of Bowel function recovery | Up to 72 hours postoperatively | 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 |
| Length of hospital stay | From admittance to discharge | Determined by the number of days from admittance to discharge |
| The postoperative sleep quality score | Up to 72 hours postoperatively | 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. |
| The anxiety and depression scores | Up to 72 hours postoperatively | 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). |
| The incidence of chronic postsurgical pain (CPSP) | 3 months after surgery | 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. |
| Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery | Up to 72 hours postoperatively | 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) |
Countries
China
Contacts
Primary ContactChunling Jiang, PhD
Outcome results
None listed