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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty (THA)

6. mai 2026 oppdatert av: Poznan University of Medical Sciences

Comparison of the Efficacy and Safety of Three Regional Anesthesia Strategies in Patients Undergoing Elective Total Hip Arthroplasty: A Prospective, Randomized, Multicenter Clinical Trial

The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty.

The main questions this study aims to answer are:

Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone.

Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation.

The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Postoperative pain after total hip arthroplasty is associated with increased opioid use, delayed mobilization, and a higher risk of adverse events, particularly in older adults. Spinal anesthesia with intrathecal morphine is widely used to improve postoperative analgesia; however, it may be associated with opioid-related side effects such as nausea, pruritus, urinary retention, and respiratory depression. Ultrasound-guided regional nerve blocks, including the pericapsular nerve group (PENG) block, have emerged as opioid-sparing alternatives that may provide effective analgesia while preserving motor function.

This prospective, randomized, multicenter clinical trial is designed to compare the efficacy and safety of three regional anesthesia strategies in patients undergoing elective total hip arthroplasty. Participants aged 60 years and older will be randomly assigned in a 1:1:1 ratio to one of three study groups: spinal anesthesia with intrathecal morphine; spinal anesthesia combined with a PENG block; or spinal anesthesia combined with a PENG block using perineural dexamethasone as an adjuvant.

All participants will receive standardized spinal anesthesia with ropivacaine. In the control group, intrathecal morphine will be administered as part of routine spinal anesthesia. In the intervention groups, the PENG block will be performed under ultrasound guidance using ropivacaine, with or without the addition of dexamethasone. Perioperative care, postoperative analgesic protocols, and rehabilitation pathways will be standardized across all study centers to minimize variability.

Pain intensity at rest and during movement will be assessed using a visual analog scale at predefined time points within the first 48 hours after surgery. Secondary outcomes include total opioid consumption, time to first rescue analgesia, early mobilization, length of hospital stay, incidence of opioid-related and block-related adverse events, and changes in inflammatory markers measured in peripheral blood.

The results of this study will provide comparative evidence on opioid-based versus opioid-sparing regional anesthesia strategies for hip arthroplasty and may help inform clinical decision-making aimed at improving postoperative pain control, functional recovery, and safety in older surgical patients.

Studietype

Intervensjonell

Registrering (Antatt)

90

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

  • Polen
      • Poznan, Polen, 62-701
        • Poznan University of Medical Sciences

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adults aged 60 to 100 years
  • Scheduled for elective total hip arthroplasty
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

  • Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone
  • Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks
  • Infection at the site of spinal or peripheral nerve block injection
  • Pre-existing neurological disorders affecting sensory or motor function
  • Severe hepatic or renal insufficiency
  • Chronic opioid use for more than 3 months prior to surgery
  • Refusal or inability to provide informed consent

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Spinal Anesthesia With Intrathecal Morphine
Participants will receive spinal anesthesia with intrathecal ropivacaine combined with intrathecal morphine. Ropivacaine 0.5% (10-15 mg) will be administered intrathecally, followed by intrathecal morphine at a dose of 100 micrograms as part of standard anesthesia care.
Legemiddel: Intrathecal Morphine
Intrathecal morphine administered as part of spinal anesthesia for postoperative pain control during elective total hip arthroplasty.
Andre navn:
  • Morphine (intrathecal)
Eksperimentell: Spinal Anesthesia Plus PENG Block
Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% administered as a single injection.
Fremgangsmåte: Pericapsular Nerve Group Block
Ultrasound-guided pericapsular nerve group block performed as an adjunct to spinal anesthesia to provide postoperative analgesia.
Andre navn:
  • PENG-blokk
Eksperimentell: Spinal Anesthesia Plus PENG Block With Dexamethasone
Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% with the addition of dexamethasone 4 mg administered perineurally as a single injection.
Legemiddel: Dexamethasone
Perineural dexamethasone administered as an adjuvant to the pericapsular nerve group block to prolong postoperative analgesia.
Andre navn:
  • Dexamethasone (perineural)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Postoperative Opioid Consumption
Tidsramme: Up to 48 hours after surgery
Total amount of opioids administered postoperatively, expressed as intravenous morphine equivalents.
Up to 48 hours after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain scores at rest
Tidsramme: 6 hours after surgery
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
6 hours after surgery
Pain scores durring movement
Tidsramme: 6 hours after surgery
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
6 hours after surgery
Pain scores at rest
Tidsramme: 12 hours after surgery
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
12 hours after surgery
Pain scores durring movement
Tidsramme: 12 hours after surgery
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
12 hours after surgery
Pain scores at rest
Tidsramme: 24 hours after surgery
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
24 hours after surgery
Pain scores durring movement
Tidsramme: 24 hours after surgery
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
24 hours after surgery
Pain scores at rest
Tidsramme: 48 hours after surgery
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
48 hours after surgery
Pain scores durring movement
Tidsramme: 48 hours after surgery
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
48 hours after surgery
Time to First Rescue Analgesia
Tidsramme: Up to 48 hours after surgery.
Time from the end of surgery to the first request for rescue analgesic medication.
Up to 48 hours after surgery.
Early Mobilization
Tidsramme: Up to 48 hours after surgery
Time to first mobilization assessed using the Timed Up and Go test.
Up to 48 hours after surgery
Incidence of Opioid-Related Adverse Events
Tidsramme: Up to 48 hours after surgery.
Occurrence of opioid-related adverse events, including nausea, vomiting, pruritus, and urinary retention.
Up to 48 hours after surgery.
Length of Hospital Stay
Tidsramme: measured at the day of the discharge from the hospital
Total duration of postoperative hospitalization measured in days.
measured at the day of the discharge from the hospital

Samarbeidspartnere og etterforskere

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

Sponsor

Poznan University of Medical Sciences

Etterforskere

  • Studiestol: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences

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 (Antatt)

1. juni 2026

Primær fullføring (Antatt)

31. mars 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

13. mars 2026

Først innsendt som oppfylte QC-kriteriene

6. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1/2026 (Powiślańska Akademia Nauk Stosowanych w Kwidzynie)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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