Effect of Transcutaneous Electrical Acupoint Stimulation on Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy
| Registry | NCT03912688, acronym TRIM |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: triple, treatment |
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| Enrollment | 153 (Actual) |
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| Sponsor | Air Force Military Medical University, China (Other) |
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| Conditions | Anesthesia, Pain |
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| Interventions | acupoint stimulation, single acupoint, dual acupoints (Device) |
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| Dates | start 2015-07-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2019-04-11, last updated 2019-04-11 |
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Related Papers Related Patents Related Grants Related Experts
All trials for Anesthesia All trials for Pain All trials of acupoint stimulation All trials of single acupoint
-Summary
Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. The present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| single acupoint stimulation | Experimental | Device: acupoint stimulation; Device: single acupoint | |
| dual acupoints stimulation | Experimental | Device: acupoint stimulation; Device: dual acupoints | |
| no stimulation | No intervention | | |
- acupoint stimulation (Device)
- single acupoint (Device)
- dual acupoints (Device)
+Outcome measures
Primary outcomes
- consumption of remifentanil [from start of anesthesia to extubation, on average 2 hours]
Secondary outcomes
- time to recall [from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average]
- time to extubation [from end of remifentanil infusion to extubation,approximately 10 minutes on average]
- respiratory depression [end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes]
- nausea and vomiting [end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes]
- visual analogue scale of pain [end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes]: pain intensity is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain
- patients' satisfaction score [from end of surgery to 24 hours after surgery, totally 24 hours]: patients' satisfaction score is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain
- incidence of pain at 3m after surgery [from discharge from hospital to 3 months after surgery, approximately 3 months]: percentage of patients suffering from pain around the incision
- incidence of pain at 6m after surgery [from discharge from hospital to 6 months after surgery, approximately 3 months]: percentage of patients suffering from pain around the incision
+Eligibility
Sex: Female, ages: 18 Years to 65 Years
Inclusion Criteria:
* 18 to 65 yrs
* body mass index (BMI) of 18 to 30 kg/m2
* elective radical mastectomy under general anaesthesia
Exclusion Criteria:
* contradictions to TEAS
* difficulties in communication
* histories of general anaesthesia
* drug or alcohol abuse or addiction
* cardiac dysfunction or severe hypertension
* confirmed hepatic dysfunction and renal impairment
* the participants recruited into other clinical trials during last three months
+Publications
- Kuhn LA. Editorial: Acupuncture anesthesia for open heart surgery. Am J Cardiol. 1974 Aug;34(2):254-5. doi: 10.1016/0002-9149(74)90207-0. No abstract available. PMID 4843161
- Results publication: Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227. PMID 26170347
- Results publication: Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26. PMID 24576720
- Results publication: Yan B, Li K, Xu J, Wang W, Li K, Liu H, Shan B, Tang X. Acupoint-specific fMRI patterns in human brain. Neurosci Lett. 2005 Aug 5;383(3):236-40. doi: 10.1016/j.neulet.2005.04.021. PMID 15876491