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

20 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Tomasz Reysner, MD PhD
  • Numero di telefono: +48 (61) 831-01-22
  • Email: treysner@ump.edu.pl

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Comparatore attivo: 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.
Droga: 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.
Altri nomi:
  • Lumbar Erector Spinae Plane Block (L-ESPB)
Droga: 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.
Altri nomi:
  • Lumbar Paravertebral Block (L-PVB)
Comparatore attivo: 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.
Droga: 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.
Altri nomi:
  • Lumbar Erector Spinae Plane Block (L-ESPB)
Droga: 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.
Altri nomi:
  • Lumbar Paravertebral Block (L-PVB)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total opioid consumption within 48 hours after surgery
Lasso di tempo: 48 hours postoperatively
Total cumulative opioid consumption within the first 48 hours after surgery, converted to intravenous morphine equivalents.
48 hours postoperatively

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first rescue analgesia
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 12 hours after surgery
serum interleukin-6 (IL-6) level
12 hours after surgery
Interleukin-6 (IL-6) level
Lasso di tempo: 24 hours after surgery
serum interleukin-6 (IL-6) level
24 hours after surgery
Interleukin-6 (IL-6) level
Lasso di tempo: 48 hours after surgery
serum interleukin-6 (IL-6) level
48 hours after surgery
NLR
Lasso di tempo: 12 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
12 hours after surgery
NLR
Lasso di tempo: 24 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
24 hours after surgery
NLR
Lasso di tempo: 48 hours after surgery
neutrophil-to-lymphocyte ratio (NLR)
48 hours after surgery
PLR
Lasso di tempo: 12 hours after surgery
platelet-to-lymphocyte ratio (PLR)
12 hours after surgery
PLR
Lasso di tempo: 24 hours after surgery
platelet-to-lymphocyte ratio (PLR)
24 hours after surgery
PLR
Lasso di tempo: 48 hours after surgery
platelet-to-lymphocyte ratio (PLR)
48 hours after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Poznan University of Medical Sciences

Investigatori

  • Cattedra di studio: Katarzyna Wieczorowska-Tobis, MD PhD, Poznan University of Medical Sciences
  • Direttore dello studio: Małgorzata Reysner, Md PhD, Poznan University of Medical Sciences

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 luglio 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 4/2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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