Nylon versus polyuretan epidural katetre hos pasienter som gjennomgår større ortopedisk kirurgi
Objectives: To compare the safety and efficacy of nylon (polyamide) epidural catheter versus polyurethane epidural catheter in patients undergoing major orthopedic surgery under continuous epidural anesthesia.
Background: Continuous epidural anesthesia is the most common anesthetic technique used in orthopedic surgery. However, the use of epidural catheters is associated with complications. The insertion of the catheter may be associated with intravascular or intrathecal placement, nerve root irritation, paresthesia, kinking, hematoma, or breakage during catheter removal.
Patients and Methods: This was a prospective, randomized, double-blind clinical trial; carried out on 60 patients undergoing major orthopedic surgery under continuous epidural anesthesia. Patients were randomly allocated into two equal groups; group N, using Nylon catheter, and group P, using Polyurethane catheter.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ahmed M Shaat, MD
- Telefonnummer: 00201223482709
- E-post: ahmedshaat99@gmail.com
Studiesteder
-
-
El-Beheira
-
Damanhūr, El-Beheira, Egypt
- Rekruttering
- Damanhour Teaching Hospital
-
Ta kontakt med:
- Ahmed M Shaat, MD
- Telefonnummer: 00201223482709
- E-post: ahmedshaat99@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 21 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Contraindications to regional anesthesia (including coagulopathy and infection at the injection site)
- Uncooperative patients
- Patients with known allergy to local anesthetics or opioids
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Group N (n=30)
Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter |
Nylon (Polyamide) Epidural Catheter |
|
Aktiv komparator: Group P (n=30)
Continuous Epidural Anesthesia using Polyurethane Epidural Catheter |
Polyurethane Epidural Catheter |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean and Standard deviation of Time required for epidural catheter insertion (seconds) (mean±SD)
Tidsramme: 2 minutes after identifying the epidural space by loss of resistance technique
|
Time interval from holding the epidural catheter by the anesthetist till removal of the Tuohy needle through the epidural catheter by the anesthetist |
2 minutes after identifying the epidural space by loss of resistance technique
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean and Standard deviation of Time required for epidural catheter to anchor with the catheter connector (seconds) (mean±SD)
Tidsramme: 2 minutes after removal of the Tuohy needle through the epidural catheter
|
Time interval from holding the epidural catheter by the anesthetist till anchoring it with the catheter connector by the anesthetist |
2 minutes after removal of the Tuohy needle through the epidural catheter
|
|
Mean and Standard deviation of Time required for epidural catheter removal (seconds) (mean±SD)
Tidsramme: 2 minutes after the end of the operation
|
Time interval from holding the epidural catheter by the anesthetist till removal of the epidural catheter by the anesthetist |
2 minutes after the end of the operation
|
|
Number of participants and Rate of Catheter-related complications
Tidsramme: 2 minutes after the end of the operation
|
Number of participants and Rate of: Catheter kink, Catheter stretch, Difficult catheter insertion, Intravascular placement, Intrathecal placement, Paresthesia, Failure (asymmetric, unilateral, no block at 30 min), Hematoma, Breakage during removal. |
2 minutes after the end of the operation
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ahmed M Shaat, MD, Damanhour Teaching Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- DTH: 21003
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