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Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery

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

A Prospective, Randomized Controlled Trial Comparing the Analgesic Efficacy of Lumbar Paravertebral Block and Lumbar Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery

This prospective, randomized controlled trial aims to compare the analgesic efficacy of lumbar paravertebral block (L-PVB) and lumbar erector spinae plane block (L-ESPB) in elderly patients undergoing lumbar spine surgery. Effective postoperative pain management in this population is essential due to increased susceptibility to opioid-related adverse effects.

Participants aged 65 years and older will be randomly assigned to receive either bilateral L-PVB or bilateral L-ESPB in addition to standardized general anesthesia. The primary objective is to evaluate differences in postoperative opioid consumption within the first 48 hours after surgery. Secondary outcomes include pain intensity, intraoperative opioid use, time to mobilization, length of hospital stay, and incidence of opioid-related adverse events.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Lumbar spine surgery is associated with significant postoperative pain, particularly in elderly patients, who are at increased risk of opioid-related adverse effects such as respiratory depression, sedation, delirium, and delayed mobilization. Regional anesthesia techniques may improve postoperative analgesia and reduce opioid requirements in this population.

The lumbar paravertebral block (L-PVB) is a well-established technique providing segmental analgesia by targeting spinal nerves in the paravertebral space. The erector spinae plane block (L-ESPB), a newer interfascial plane block, has gained popularity due to its technical simplicity and favorable safety profile. However, comparative data on their effectiveness in lumbar spine surgery, especially in elderly patients, remain limited.

This study is designed as a prospective, randomized, controlled trial comparing L-PVB and L-ESPB in patients aged 65 years and older undergoing elective lumbar spine surgery under general anesthesia. Participants will be randomly allocated in a 1:1 ratio to receive either bilateral L-PVB or bilateral L-ESPB with a standardized dose of local anesthetic.

All patients will receive a standardized general anesthesia protocol and multimodal analgesia regimen. Postoperative pain management will follow a uniform protocol across both groups.

The primary endpoint is total opioid consumption within 48 hours after surgery, expressed as intravenous morphine equivalents. Secondary endpoints include intraoperative opioid consumption, postoperative pain scores at predefined time points, time to first mobilization, length of hospital stay, use of rescue analgesia, and incidence of opioid-related adverse effects. Exploratory analyses will include assessment of inflammatory markers.

Studietype

Intervensjonell

Registrering (Antatt)

120

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

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • ge ≥65 years
  • Scheduled for elective lumbar spine surgery
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to assess pain using the Numeric Rating Scale (NRS)
  • Provision of written informed consent

Exclusion Criteria:

  • Refusal to participate
  • Chronic opioid therapy
  • Coagulation disorders
  • Use of anticoagulant therapy contraindicating regional anesthesia
  • Infection at the planned needle insertion site
  • Allergy to ropivacaine or other study-related medications
  • Severe hepatic failure
  • Severe renal failure
  • Cognitive impairment preventing reliable pain assessment
  • Inability to cooperate with study procedures
  • Extensive reoperation or surgery of unusually large extent that may interfere with outcome assessment
  • Contraindications to general anesthesia or regional anesthesia

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: General Anesthesia Alone (GA-only)
Participants will receive standardized general anesthesia and multimodal postoperative analgesia according to institutional protocol. No regional anesthesia technique will be performed.
Aktiv komparator: General Anesthesia + Lumbar Erector Spinae Plane Block (L-ESPB)
Participants will receive standardized general anesthesia combined with bilateral lumbar erector spinae plane block (L-ESPB) performed under ultrasound guidance. Ropivacaine 0.2% will be administered at a volume of 20 mL per side (total 40 mL). No adjuvants will be used. All patients will receive standardized multimodal postoperative analgesia.
Legemiddel: Ropivacaine 0.2% Injectable Solution
Ultrasound-guided bilateral interfascial plane block performed at the lumbar level for postoperative analgesia in patients undergoing lumbar spine surgery.
Andre navn:
  • Lumbar Erector Spinae Plane Block (L-ESPB)
Legemiddel: Ropivacaine 0.2% Injectable Solution
Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery.
Andre navn:
  • Lumbar Paravertebral Block (L-PVB)
Aktiv komparator: General Anesthesia + Lumbar Paravertebral Block (L-PVB)
Participants will receive standardized general anesthesia combined with bilateral lumbar paravertebral block (L-PVB) performed under ultrasound guidance. Ropivacaine 0.2% will be administered at a volume of 20 mL per side (total 40 mL). No adjuvants will be used. All patients will receive standardized multimodal postoperative analgesia.
Legemiddel: Ropivacaine 0.2% Injectable Solution
Ultrasound-guided bilateral interfascial plane block performed at the lumbar level for postoperative analgesia in patients undergoing lumbar spine surgery.
Andre navn:
  • Lumbar Erector Spinae Plane Block (L-ESPB)
Legemiddel: Ropivacaine 0.2% Injectable Solution
Ultrasound-guided bilateral paravertebral block at the lumbar level targeting spinal nerves for postoperative analgesia in patients undergoing lumbar spine surgery.
Andre navn:
  • Lumbar Paravertebral Block (L-PVB)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total opioid consumption within 48 hours after surgery
Tidsramme: 48 hours postoperatively
Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents.
48 hours postoperatively

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to first rescue analgesia
Tidsramme: 48 hours after surgery
Time from completion of the surgery to the administration of the first dose of rescue opioid analgesic (in minutes).
48 hours after surgery
Postoperative pain intensity at rest (NRS)
Tidsramme: 0 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
0 hours postoperatively
Postoperative pain intensity at rest (NRS)
Tidsramme: 2 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
2 hours postoperatively
Postoperative pain intensity at rest (NRS)
Tidsramme: 6 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
6 hours postoperatively
Postoperative pain intensity at rest (NRS)
Tidsramme: 12 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
12 hours postoperatively
Postoperative pain intensity at rest (NRS)
Tidsramme: 24 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
24 hours postoperatively
Postoperative pain intensity at rest (NRS)
Tidsramme: 48 hours postoperatively
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
48 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Tidsramme: 0 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
0 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Tidsramme: 2 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
2 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Tidsramme: 6 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
6 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Tidsramme: 12 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
12 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Tidsramme: 24 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
24 hours postoperatively
Postoperative pain intensity at during movement (NRS)
Tidsramme: 48 hours postoperatively
Pain intensity at during movementassessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
48 hours postoperatively
Interleukin-6 (IL-6) level
Tidsramme: 12 hours after surgery
serum interleukin-6 (IL-6) level
12 hours after surgery
Interleukin-6 (IL-6) level
Tidsramme: 24 hours after surgery
serum interleukin-6 (IL-6) level
24 hours after surgery
Interleukin-6 (IL-6) level
Tidsramme: 48 hours after surgery
serum interleukin-6 (IL-6) level
48 hours after surgery
NLR
Tidsramme: 12 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
12 hours after surgery
NLR
Tidsramme: 24 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
24 hours after surgery
NLR
Tidsramme: 48 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
48 hours after surgery
PLR
Tidsramme: 12 hours after surgery
platelet-to-lymphocyte ratio (PLR)
12 hours after surgery
PLR
Tidsramme: 24 hours after surgery
platelet-to-lymphocyte ratio (PLR)
24 hours after surgery
PLR
Tidsramme: 48 hours after surgery
platelet-to-lymphocyte ratio (PLR)
48 hours after surgery

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: Katarzyna Wieczorowska-Tobis, MD PhD, Poznan University of Medical Sciences
  • Studieleder: Małgorzata 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. juli 2027

Studiet fullført (Antatt)

31. august 2027

Datoer for studieregistrering

Først innsendt

6. mai 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 4/2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data (IPD) underlying the results reported in this study, after de-identification, will be made available to researchers upon reasonable request. The shared data will include demographic data, intervention allocation, and outcome measures.

IPD-delingstidsramme

Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.

Tilgangskriterier for IPD-deling

Access to the data will be provided to researchers who submit a methodologically sound proposal. Requests will be reviewed by the principal investigator. Data will be shared after approval of a data access agreement.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

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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