Acute Pain, Chronic Pain, Postoperative
Conditions
Keywords
mastectomy, transcutaneous electrical acupoint stimulation, acute pain, chronic pain
Brief summary
The purpose of this study is to evaluate the effects of transcutaneous electric acupoint stimulation(TEAS) at single acupoint or dual acupoints on opioid consumption and postoperative pain in patients undergoing radical mastectomy
Interventions
OTHERtranscutaneous electric acupoint stimulation
electrodes are attached o the skin and electric stimulation is given
OTHERelectrode attached but no stimulation
electrodes are attached o the skin but no stimulation is given
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
For all patients, electrodes were placed at the bilateral PC6 and RN17 and connected to the Hwato Electric Acupuncture Treatment Instrument. No patients in the study had previous experience of undergoing transcutaneous electrical stimulation treatment. Patients were told that they might or might not feel the electrical stimulation. Interventions were performed by a designated investigator who was not involved in the anaesthesia or the follow-up. The stimulator was placed in an opaque box to blind the surgical team and the anaesthetists to the group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients aged from 18 to 65 yrs * body mass index (BMI) of 18 to 30 kg/m2 * elective radical mastectomy under general anesthesia
Exclusion criteria
* contradictions to electric stimulation * difficulties in communication * histories of general anesthesia, drug or alcohol abuse or addiction * cardiac dysfunction or severe hypertension, confirmed hepatic dysfunction and renal impairment * participants recruited into other clinical trials during last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose of remifentanil during anesthesia | from start of anesthesia to extubation, on average 2 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to extubation | from end of remifentanil infusion to extubation,approximately 10 minutes on average | — |
| incidence of respiratory depression during recovery | from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average | — |
| incidence of nausea and vomiting during recovery | from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average | — |
| time to recall | from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average | patient response to verbal command |
| visual analogue scale at 24 hour after surgery | from end of surgery to 24 hours after surgery, totally 24 hours | — |
| pain score at 3 months after surgery | from discharge from hospital to 3 months after surgery, approximately 3 months | — |
| pain score at 6 months after surgery | from discharge from hospital to 6 months after surgery, approximately 3 months | — |
| visual analogue scale during recovery | from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average | — |
Countries
China
Outcome results
None listed