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Predictors of Unilateral Spinal Block Success (UNISS)

6. mai 2026 oppdatert av: Derya Arslan Yurtlu, Izmir City Hospital

Determination of Factors Affecting Success in Unilateral Spinal Anesthesia: A Prospective Observational Study

This prospective observational study aims to determine the factors affecting the success of unilateral spinal anesthesia in patients undergoing orthopedic lower extremity surgery. Unilateral spinal anesthesia is preferred to minimize unwanted effects such as hypotension and to provide more stable hemodynamic conditions, especially in vulnerable patient populations.

Unilateral spinal anesthesia is defined as achieving sensory and motor block predominantly on the operated side without significant contralateral spread. However, the factors influencing the success of this technique have not been fully clarified.

This study will evaluate various patient-related and procedure-related factors, including age, sex, body mass index, patient positioning, needle type and orientation, injection technique and local anesthetic dose. The primary outcome is the success of unilateral spinal anesthesia, defined as the absence of contralateral block.

The results of this study are expected to contribute to improving clinical practice by identifying major and minor factors affecting block success and optimizing anesthesia techniques.

Studieoversikt

Detaljert beskrivelse

This prospective observational study is designed to investigate the factors influencing the success of unilateral spinal anesthesia in patients undergoing lower extremity orthopedic surgery.

Spinal anesthesia is widely used in lower extremity procedures; however, it may be associated with hemodynamic instability such as hypotension. Unilateral spinal anesthesia has been proposed as a technique to limit sympathetic blockade and maintain more stable hemodynamic conditions. Despite its advantages, the determinants of successful unilateral block remain unclear.

Patients aged between 18 and 65 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective lower extremity surgery will be included in the study after providing written informed consent. This study will be conducted in a single tertiary care center.

No intervention will be performed by the investigator. All anesthesia procedures will be carried out according to routine clinical practice. The investigator will record patient demographics, including age, sex, height, weight, and body mass index.

Procedure-related variables such as patient positioning, spinal needle type, needle orientation, injection speed, level of injection, local anesthetic type and dose will be recorded.

Block characteristics will be assessed intraoperatively, including sensory and motor block distribution. The primary outcome is defined as successful unilateral spinal anesthesia, characterized by the absence of contralateral sensory block. Secondary outcomes include factors associated with block success and variability in block characteristics.

Data will be collected using standardized case report forms and analyzed to identify factors influencing the success of unilateral spinal anesthesia. The results of this study are expected to contribute to optimizing anesthesia techniques and improving patient safety.

Studietype

Observasjonsmessig

Registrering (Faktiske)

318

Kontakter og plasseringer

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

Studiesteder

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

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients aged 18-65 years with ASA physical status I-III undergoing elective unilateral lower extremity surgery under spinal anesthesia in a single tertiary care center.

Beskrivelse

Inclusion Criteria:

  • Patients aged 18-65 years
  • ASA physical status I-III
  • Undergoing elective unilateral lower extremity surgery under spinal anesthesia
  • Provided written informed consent

Exclusion Criteria:

  • ASA IV patients
  • Known allergy to local anesthetics
  • Contraindications to spinal anesthesia
  • Decompensated congestive heart failure
  • Hemodynamic instability (including sepsis, septic shock, or need for inotropic support)
  • Pregnancy
  • Patients with vertebral anomalies (e.g., scoliosis, vertebral fractures) preventing proper positioning

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
patients undergoing unilateral spinal anesthesia
Patients aged 18-65 years with ASA physical status I-III undergoing elective unilateral lower extremity surgery under spinal anesthesia.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Unilateral Spinal Block Success Rate
Tidsramme: Intraoperative period (within first 30 minutes after spinal anesthesia
Successful unilateral spinal anesthesia defined as the absence of contralateral sensory block, assessed by pinprick test and bromage scale within the first 20 minutes after spinal anesthesia.
Intraoperative period (within first 30 minutes after spinal anesthesia

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of unilateral spinal anesthesia success by age
Tidsramme: Intraoperative period
Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Intraoperative period
Rate of unilateral spinal anesthesia success by BMI
Tidsramme: Intraoperative period
Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Intraoperative period
Rate of unilateral spinal anesthesia success by position
Tidsramme: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by patient positioning during injection (lateral vs sitting).
Intraoperative period
Rate of unilateral spinal anesthesia success by needle type
Tidsramme: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by spinal needle type (Quincke vs pencil-point).
Intraoperative period
Rate of unilateral spinal anesthesia success by needle gauge
Tidsramme: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by needle gauge.
Intraoperative period
Rate of unilateral spinal anesthesia success by local aneshtetic dose
Tidsramme: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by administered local anesthetic dose (mg).
Intraoperative period
Rate of unilateral spinal anesthesia success by injection speed
Tidsramme: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by injection speed category (faster vs ≤1 mL/5 s).
Intraoperative period
Sensory Block Level and Distribution
Tidsramme: Intraoperative period
Assessment of sensory block level (dermatomal level) and comparison between operated and non-operated sides.
Intraoperative period
Rate of unilateral spinal anesthesia success by intervertebral level of spinal injection
Tidsramme: Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by intervertebral level (L1-2,L2-3,L3-L4 ,L4-L5).
Intraoperative period

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Derya Arslan Yurtlu, MD, İzmir City Hospital

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)

10. august 2025

Primær fullføring (Faktiske)

1. februar 2026

Studiet fullført (Faktiske)

1. februar 2026

Datoer for studieregistrering

Først innsendt

9. april 2026

Først innsendt som oppfylte QC-kriteriene

6. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared due to patient confidentiality and institutional data protection policies

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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