Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy (ASDAS)
14. oktober 2019 opdateret af: Zhihong LU
Effect of Combined-acupoint or Single-acupoint Stimulation Before Surgery on Post Mastectomy Pain: a Multicentre Randomised Controlled Trial
The purpose of this study is to compare the effects of dual acupoints and single acupoint transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients were randomly assigned to three groups, receiving 30min TEAS before anesthesia respectively.
The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), single point group is bilateral Neiguan points(PC6), and the false stimulation group only attach electrodes without electric current.
The frequency of TEAS is set to 2/15 Hz.
Intraoperative anesthetic dosage of propofol and remifentanil was recorded.
Three and six months after surgery, follow-up about chronic pain was made by telephone or face-to-face using the follow-up questionnaire.
The adverse events were recorded.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
593
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Chongqing
-
Chongqing, Chongqing, Kina
- First Afiliated Hospital of Chongqing Medical University
-
-
Henan
-
Zhengzhou, Henan, Kina, 450003
- People's Hospital of Zhengzhou University
-
Zhengzhou, Henan, Kina, 450052
- First Afiliated Hospital of Zhengzhou University
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710032
- Xijing hospital, Fourth military medical university
-
Xi'an, Shaanxi, Kina, 710005
- Tangdu Hospital, Fourth Military Medical University
-
Xi'an, Shaanxi, Kina, 710022
- First Afiliated Hospital of Xi'an Jiaotong University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Scheduled for operation of breast cancer；
- ASA（American Society of Anesthesiologists）I-II；
- Aged between 18 and 65；
- Informed consented。
Exclusion Criteria:
- Suffered from the contraindication of TEAS including the local skin breakage, infection or planted with the electrophysiology device；
- Unable to communicate and coordinate with the researcher, such as suffering from language comprehension deficits or mental diseases；
- Certain/suspicious addiction with alcohol, analgesics or other drugs；
- Unstable Angina or myocardial infarction occurred in 3 months; NYHA（New York Heart Association） is 3 or higher;
- Blood pressure ≥ 180/110 mm Hg while preoperative visiting;
- Suffered from diabetic complications including diabetic ketoacidosis, hyperosmolar coma, infection, macroangiopathy, diabetic nephropathy, retinopathy, cardiomyopathy, neuropathy and diabetic foot;
- Severe dysfunction of liver or kidney meaning one of ALT（Alanine Transaminase）, AST（Aspartate Transaminase）, ALP（alkaline phosphatase） or TBIL（total bilirubin） is 2 times higher that normal or creatinine clearance < 30 ml/min or serum creatinine > 177umol/L;
- Participate in the other clinical trial 3 month before the enrollment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: dual acupoint stimulation
The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), electric stimulation was given through electrode attached to the acupoints.
|
Electric stimulation was given through electrode attached to acupoints
Andre navne:
|
|
Eksperimentel: single acupoint stimulation
The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints.
|
Electric stimulation was given through electrode attached to acupoints
Andre navne:
|
|
Placebo komparator: no stimulation
false stimulation group only attach electrodes without electric current.
|
patients were only attached electrodes without electric current
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of chronic pain six months after surgery
Tidsramme: six months after surgery
|
six months after surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of chronic pain three months after surgery
Tidsramme: three months after surgery
|
three months after surgery
|
|
Remifentanil consumption during the surgery
Tidsramme: from start of surgery to end of surgery, at an average of 2.5 hours
|
from start of surgery to end of surgery, at an average of 2.5 hours
|
|
the time to the first verbal response
Tidsramme: end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
|
end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
|
|
the time to extubation
Tidsramme: end of the anesthetics infusion to extubation,on an average of 30 minutes
|
end of the anesthetics infusion to extubation,on an average of 30 minutes
|
|
postoperative nausea and vomiting within 24 h after surgery
Tidsramme: end of surgery to 24 hours after surgery,on an average of 24 hours
|
end of surgery to 24 hours after surgery,on an average of 24 hours
|
|
respiratory depression within 24 hours after surgery
Tidsramme: end of surgery to 24 hours after surgery,on an average of 24 hours
|
end of surgery to 24 hours after surgery,on an average of 24 hours
|
|
patients' s satisfaction scores on analgesia within 24 hours after surgery
Tidsramme: end of surgery to 24 hours after surgery,on an average of 24 hours
|
end of surgery to 24 hours after surgery,on an average of 24 hours
|
|
Visual Analogue Scale scores within 24 hours after surgery
Tidsramme: end of surgery to 24 hours after surgery,on an average of 24 hours
|
end of surgery to 24 hours after surgery,on an average of 24 hours
|
|
demand of rescue analgesics within 24 hours after surgery
Tidsramme: end of surgery to 24 hours after surgery,on an average of 24 hours
|
end of surgery to 24 hours after surgery,on an average of 24 hours
|
|
pain score at 3m after surgery
Tidsramme: three months after surgery
|
three months after surgery
|
|
pain score at 6m after surgery
Tidsramme: six months after surgery
|
six months after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Hailong Dong, Air Force Military Medical University, China
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. maj 2016
Primær færdiggørelse (Faktiske)
23. oktober 2017
Studieafslutning (Faktiske)
23. oktober 2018
Datoer for studieregistrering
Først indsendt
13. april 2016
Først indsendt, der opfyldte QC-kriterier
13. april 2016
Først opslået (Skøn)
18. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. oktober 2019
Sidst verificeret
1. oktober 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- XJH-A-2016-04-12
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
IPD including those about primary endpoint and secondary endpoints would be available to other researchers.
IPD-delingstidsramme
the data will become available after manuscript published, for 5 years.
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
- Formular til informeret samtykke (ICF)
- Klinisk undersøgelsesrapport (CSR)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .