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Pre-emptive Dexamethasone in Hip Arthroplasty

30. juni 2022 oppdatert av: Sameh Abdelkhalik Ahmed Ismaiel, Tanta University

The Effect of Pre-emptive Dexamethasone on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study

  • Certain studies suggested that preoperative administration of systemic glucocorticoids in patients undergoing hip or knee arthroplasty surgery may improve the postoperative analgesia owing to their anti-inflammatory effect.
  • This study will be carried out on 70 adult patients aged 21 to 75 years admitted to orthopedic operating rooms in Tanta university hospitals for hip surgery under spinal anesthesia. Informed written consent will be obtained from each participant.
  • Patients will be randomly distributed into two equal groups using the computer-generated software.

    • Control Group: (35 patients) Those patients will receive 10 ml of normal saline before surgery.
    • Dexamethasone Group: (35 patients) Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
  • Primary outcome will be postoperative morphine consumption and the secondary outcome will be the postoperative pain score

Studieoversikt

Status

Rekruttering

Detaljert beskrivelse

- This randomized controlled prospective study will be carried out on 70 adult patients aged 21 to 75 years admitted to orthopedic operating rooms in Tanta University Hospital for hip surgery under spinal anesthesia. I

Patients will be randomly distributed into two equal groups using the computer-generated software. An anesthesia resident who will be blinded to the study groups and not participating in it will help in the preparation of uniform 10-ml syringes that contain normal saline in the control group and 16 mg dexamethasone in the other group.

  • Control Group: (35 patients) Those patients will receive 10 ml of normal saline before surgery.
  • Dexamethasone Group: (35 patients) Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.

All the patients will undergo standardized preoperative assessment consisted of history taking, general and regional examination, and requesting preoperative investigations including (complete blood count (CBC), coagulation profile, and renal function tests). Upon patient admission to the operating theater, they will be attached to a monitor consisting of pulse oximetry, 5 lead ECG, non-invasive blood pressure, end-tidal carbon dioxide (Co2), and temperature. Then, intravenous access will be established through the insertion of an 18-gauge peripheral venous cannula, then, lactated ringer solution 7ml/kg over 30 minutes will be started. All the equipment required for spinal anesthesia, general anesthesia, and nerve block will be prepared by an expert anesthesiologist who will not be participating in this research. Also, the resuscitation equipment will be prepared before starting anesthesia.

Under complete aseptic precautions and local anesthetic skin infiltration with 3 ml lidocaine 1% at L3-L4 or L4-L5 intervertebral space, midline approach spinal anesthesia will be performed using a 25 G spinal needle. Once intrathecal placement will be confirmed, a mixture of 2 ml of hyperbaric bupivacaine (10 mg) and 0.5 ml of fentanyl (25 ugs) will be injected. The patient will be monitored for the hemodynamic parameters including the heart rate and the mean arterial pressure every 3 minutes. Moreover, the sensory and motor blockade will be assessed.

Oxygen will be applied to the patient with the aid of an oxygen mask at a flow rate of 4 L/min. The pinprick test from caudal to cephalic direction using a 26-gauge needle will be used to evaluate the sensory block until the sensory level reached the level of T11 or higher. The motor block will be assessed every 5 minutes by the Bromage score (grade 3: no movement, grade 2: unable to flex knees and can flex ankle, grade 1: unable to raise an extended leg but able to move the knees and ankles, grade 0: no paralysis) until reaching a score of 2 or 3. If no adequate sensory or motor blockade will be obtained within 20 minutes, the patient will receive general anesthesia and be excluded from the study. A decrease in the heart rate below 50 b/min will be managed by atropine 0.3 mg i.v, while a decrease in the mean arterial pressure below 65 mmHg will be managed by 10 mg ephedrine i.v and intravenous fluids.

Primary outcome will be postoperative morphine consumption and the secondary outcome will be the postoperative pain score

Studietype

Intervensjonell

Registrering (Forventet)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Algharbia
      • Tanta, Algharbia, Egypt, 31511
        • Rekruttering
        • Faculty of Medicine

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

21 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients ASA II and III, aged 21 to 75 years, admitted for hip arthroplasty surgery

Exclusion Criteria:

  • Patients who refused to participate in the research
  • Suspected or diagnosed coagulopathy
  • Allergy to bupivacaine
  • With major cardiac, renal, or hepatic disorders

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Control Group
The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.
The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.
Andre navn:
  • Placebo
Eksperimentell: Dexamethasone Group
Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
Andre navn:
  • Aktiv gruppe

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative morphine consumption
Tidsramme: The first postoperative day
The total dose of morphine in mg consumed in the first 24 hours after surgery
The first postoperative day

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative pain score
Tidsramme: The first postoperative day
Postoperative Numerical Rating score (NRS) will be assessed every 2 hours in the first six hours, then every 6 hours till 24 hour.
The first postoperative day

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Sameh Abdelkhalik, M.D, faculty of medicine, Tanta University

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)

23. mai 2021

Primær fullføring (Forventet)

1. september 2022

Studiet fullført (Forventet)

1. september 2022

Datoer for studieregistrering

Først innsendt

19. mai 2021

Først innsendt som oppfylte QC-kriteriene

19. mai 2021

Først lagt ut (Faktiske)

24. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juli 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.

IPD-delingstidsramme

The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.

Tilgangskriterier for IPD-deling

Contact the principal investigator

IPD-deling Støtteinformasjonstype

  • Studieprotokoll
  • Statistisk analyseplan (SAP)
  • Informert samtykkeskjema (ICF)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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