- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03204708
Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy
12. februar 2018 opdateret af: Guniz M.Koksal, Istanbul University
Evaluation of the Postoperative Analgesic Efficacy of Catheter Placed Interpectoral Region Via Open Technique in Patients Undergoing Modified Radical Mastectomy
patients undergoing modified radical mastectomy were divided into two groups.
patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area.
thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia.
patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation.
visual analog pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
patients undergoing modified radical mastectomy were divided into two groups by computer.
patients in catheter group were placed a catheter under clavipectoral fascia in the neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis at the 1/3 lateral part of clavicula.
solution included 10 ml of %0.5 bupivacain, %1 lidocain, 10 ml %0.9 sodium chloride totally 30 ml were given via the catheter for postoperative analgesia at the end of surgery.
patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation.
Patients in both groups were given dexketoprofen 50 mg iv if the VAS score was over 4. VAS scores, rescue analgesic requirement and timing, complications were recorded and compared between groups 1, 6, 12, 24 hours and 90 days after surgery.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
86
Fase
- Ikke anvendelig
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 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- American Society of Americans Class I-II
Exclusion Criteria:
- male
- allergy to local anesthetics or
- anticoagulant drug use
- central or peripheric nerve disease
- pregnancy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: iv analgesia
patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.
|
catheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis
patients were given 100 ml of tramadol 30 minutes before extubation
|
Aktiv komparator: catheter group
patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia
|
catheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis
patients were given 100 ml of tramadol 30 minutes before extubation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
VAS scores
Tidsramme: 1 hour after operation
|
patients were asked to give a point between 0 to 10 for their pain level.
0 is no pain, 10 is the strongest pain.
|
1 hour after operation
|
VAS scores
Tidsramme: 6 hours after operation
|
patients were asked to give a point between 0 to 10 for their pain level.
0 is no pain, 10 is the strongest pain.
|
6 hours after operation
|
VAS scores
Tidsramme: 12 hours after operation
|
patients were asked to give a point between 0 to 10 for their pain level.
0 is no pain, 10 is the strongest pain.
|
12 hours after operation
|
VAS scores
Tidsramme: 24 hours after operation
|
patients were asked to give a point between 0 to 10 for their pain level.
0 is no pain, 10 is the strongest pain.
|
24 hours after operation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
VAS scores
Tidsramme: 3 months after operation
|
patients were asked to give a point between 0 to 10 for their pain level.
0 is no pain, 10 is the strongest pain.
|
3 months after operation
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
rescue analgesic requirement
Tidsramme: 1, 6, 12 and 24 hours after operation
|
patients whose VAS scores were over 4 were given 50 mg of dexketoprofen in Group I, 10 ml %0.25 bupivacain in Group II
|
1, 6, 12 and 24 hours after operation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: cigdem akyol beyoglu, MD, Istanbul University
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)
15. april 2016
Primær færdiggørelse (Faktiske)
15. februar 2017
Studieafslutning (Faktiske)
28. februar 2017
Datoer for studieregistrering
Først indsendt
22. maj 2017
Først indsendt, der opfyldte QC-kriterier
28. juni 2017
Først opslået (Faktiske)
2. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 88931902-604.01.01
Plan for individuelle deltagerdata (IPD)
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Ingen
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Ingen
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