Nylon versus polyurethan epidural katetre hos patienter, der gennemgår større ortopædkirurgi
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ahmed M Shaat, MD
- Telefonnummer: 00201223482709
- E-mail: ahmedshaat99@gmail.com
Studiesteder
-
-
El-Beheira
-
Damanhūr, El-Beheira, Egypten
- Rekruttering
- Damanhour Teaching Hospital
-
Kontakt:
- Ahmed M Shaat, MD
- Telefonnummer: 00201223482709
- E-mail: ahmedshaat99@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ahmed M Shaat, MD, Damanhour Teaching Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- DTH: 21003
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .