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Comparison of Three Analgesic Strategies for Hip Fracture Surgery (HIP-3B)

27. juni 2026 oppdatert av: Başakşehir Çam & Sakura City Hospital

Comparison of the Postoperative Analgesic Efficacy of Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, and Standard Analgesia Protocol in Patients Undergoing Hip Fracture Surgery Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind, Controlled Trial

Hip fracture surgery is associated with significant postoperative pain and increased opioid requirements. Regional anesthesia techniques may improve analgesia and reduce opioid consumption. This prospective, randomized, double-blind, controlled trial aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. The primary outcome is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcome measures include postoperative pain intensity, rescue analgesic requirement, incidence of postoperative nausea and vomiting, Quality of Recovery-15 (QoR-15) score, and patient satisfaction score.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Hip fracture surgery is frequently associated with severe postoperative pain, delayed mobilization, and increased opioid consumption. Regional anesthesia techniques have been increasingly used to improve postoperative analgesia and reduce opioid-related adverse effects.

This prospective, randomized, double-blind, controlled, multicenter study aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. Patients will be randomly allocated in a 1:1:1 ratio to one of the three study groups.

All surgical procedures will be performed under spinal anesthesia. Patients assigned to the QIPB group will receive ultrasound-guided quadro-iliac plane block, whereas patients assigned to the SIFIB group will receive ultrasound-guided suprainguinal fascia iliaca block. Patients in the control group will receive standard multimodal analgesia without a regional block.

The primary outcome measure is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, quality of recovery assessed with the Quality of Recovery-15 (QoR-15) questionnaire, patient satisfaction, intraoperative opioid consumption, and block-related complications.

The study is planned to enroll 90 patients across three centers.

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

  • Tyrkia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkia (Türkiye)
        • Başakşehir Çam and Sakura City Hospital

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:

  • Adult patients aged 18 years or older
  • Patients scheduled for hip fracture surgery under spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Provision of written informed consent

Exclusion Criteria:

  • Refusal to participate
  • Contraindications to spinal anesthesia
  • Contraindications to regional anesthesia
  • Allergy to local anesthetics or study medications
  • Infection at the injection site
  • Coagulopathy or anticoagulant therapy precluding regional block
  • Cognitive impairment preventing pain assessment
  • Chronic opioid use
  • Revision surgery

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: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Quadro-Iliac Plane Block Group
Patients assigned to this group will receive ultrasound-guided quadro-iliac plane block in addition to standard multimodal analgesia following hip fracture surgery performed under spinal anesthesia.
Fremgangsmåte: Quadro-Iliac Plane Block
Ultrasound-guided quadro-iliac plane block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia.
Eksperimentell: Suprainguinal Fascia Iliaca Block Group
Patients assigned to this group will receive ultrasound-guided suprainguinal fascia iliaca block in addition to standard multimodal analgesia following hip fracture surgery performed under spinal anesthesia.
Fremgangsmåte: Suprainguinal Fascia Iliaca Block
Ultrasound-guided suprainguinal fascia iliaca block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia.
Aktiv komparator: Standard Analgesia Group
Patients assigned to this group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.
Annen: Standard Multimodal Analgesia
Patients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
Tidsramme: 24 hours after surgery
The total amount of tramadol administered during the first 24 postoperative hours will be recorded and compared among the study groups.
24 hours after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Pain Intensity at Rest
Tidsramme: At 0, 2, 6, 12, and 24 hours after surgery
Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
At 0, 2, 6, 12, and 24 hours after surgery
Time to First Rescue Analgesia
Tidsramme: Within the first 24 hours after surgery
Time from completion of surgery to the first administration of rescue analgesia, measured in hours.
Within the first 24 hours after surgery
Rescue Analgesic Requirement
Tidsramme: Within the first 24 hours after surgery
The proportion of patients requiring rescue analgesia during the first 24 hours after surgery.
Within the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Tidsramme: Within the first 24 hours after surgery
The incidence of postoperative nausea and/or vomiting during the first 24 hours after surgery will be recorded.
Within the first 24 hours after surgery
Quality of Recovery-15 (QoR-15) Score
Tidsramme: 24 hours after surgery
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
24 hours after surgery
Patient Satisfaction Score
Tidsramme: 24 hours after surgery
Patient satisfaction with postoperative pain management will be assessed using a numerical rating scale scored between 0 and 10 at postoperative 24 hours (0 = not satisfied at all, 10 = completely satisfied). Higher scores indicate greater patient satisfaction.
24 hours after surgery
Block-related Complications
Tidsramme: During the first 24 hours after surgery.
The incidence of block-related complications, including local anesthetic systemic toxicity, vascular puncture, hematoma, infection, and persistent sensory or motor deficits, will be recorded.
During the first 24 hours after surgery.

Samarbeidspartnere og etterforskere

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

Sponsor

Başakşehir Çam & Sakura City Hospital

Etterforskere

  • Hovedetterforsker: Kenan Kart, Karabuk 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 (Antatt)

15. juli 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

27. juni 2026

Først lagt ut (Faktiske)

30. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HIP-QIPB-SIFIB-2026
  • 105 (Annen identifikator: İstanbul Medipol University Clinical Research Ethics Committee)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

De-identified individual participant data will not be made publicly available.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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