- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07655921
ERAS in Total Knee Arthroplasty: a Randomized Controlled Trial (ERAS)
Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Tria
Total knee arthroplasty(TKA) is the most commonly performed procedure for advanced knee osteoarthritis. Enhanced recovery after surgery (ERAS) protocols are primarily implemented to reduce perioperative stress and improve surgical and functional outcomes. Evidence of the implementation of ERAS protocols in low to middle-income countries like Pakistan is limited. This study aims to evaluate the effectiveness of ERAS protocols in TKA patients.
A prospective randomized controlled trial study was conducted within our institute from July 2025 to January 2026, in which a total of 239 patients who underwent primary bilateral TKA, of which 121 patients received conventional treatment and protocols, and a study group with 120 participants were managed according to the ERAS protocol. Patients were in the 50-70 years age bracket, and had an American Society of Anesthesiologists grade I-III. The protocol included preoperative physiotherapy, reduced fasting time, multimodal anesthesia, perioperative tranexamic acid, early ambulation and early oral intake. Postoperative outcomes included time to oral intake, postoperative nausea and vomiting, time to mobilization, length of hospital stay, range of motion and Hospital for Special Surgery score.
Studieoversigt
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: DR MOHAMMAD ZEESHAN HAIDER, MBBS
- Telefonnummer: +923432886821
- E-mail: mohammadzh321@gmail.com
Studiesteder
-
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Sindh
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Karachi, Sindh, Pakistan, 74200
- Rekruttering
- Liaquat National Hospital
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Kontakt:
- Dr Nasir Ahmed Dr, MBBS, FCPS
- Telefonnummer: +923223586844
- E-mail: drnasir76.lnh@gmail.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- ASA grade of 1-3 BMI was restricted to less than 30 kg/m²
Exclusion Criteria:
- ASA grade of IV or higher uncontrolled comorbidities not consenting to the protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: control group
the group will receive conventional treatment protocol
|
|
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Eksperimentel: study group
eras protocol implementation in this group
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ERAS IMPLEMENTATION IN TKA PATIENTES
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
TIME TO ORAL INTAKE
Tidsramme: Baseline
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DURATION AFTER WHICH NPO WAS BROKEN
|
Baseline
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Length of hospital stay
Tidsramme: through study completion, an average of 1 year
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STAY IN THE HOSPITAL AFTER THE INTERVENTION
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through study completion, an average of 1 year
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
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
- 1197-2025-LNH-ERC
- ETHICAL REVIEW COMMITTEE (Anden identifikator: LIAQUAT NATIONAL HOSPITAL)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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