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Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy (ASDAS)

14. oktober 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

593

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: acupoint stimulation
Electric stimulation was given through electrode attached to acupoints
Andre navn:
  • transkutan elektrisk akupunktstimulering
Eksperimentell: single acupoint stimulation
The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints.
Enhet: acupoint stimulation
Electric stimulation was given through electrode attached to acupoints
Andre navn:
  • transkutan elektrisk akupunktstimulering
Placebo komparator: no stimulation
false stimulation group only attach electrodes without electric current.
Enhet: no stimulation
patients were only attached electrodes without electric current

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Zhihong LU

Etterforskere

  • Studiestol: Hailong Dong, Air Force Military Medical University, China

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. mai 2016

Primær fullføring (Faktiske)

23. oktober 2017

Studiet fullført (Faktiske)

23. oktober 2018

Datoer for studieregistrering

Først innsendt

13. april 2016

Først innsendt som oppfylte QC-kriteriene

13. april 2016

Først lagt ut (Anslag)

18. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • XJH-A-2016-04-12

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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 Støtteinformasjonstype

  • Studieprotokoll
  • Statistisk analyseplan (SAP)
  • Informert samtykkeskjema (ICF)
  • Klinisk studierapport (CSR)

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