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ESP Block Vs. QIPB for Lumbar Stabilization Surgery

24 agosto 2026 aggiornato da: Antalya City Hospital

Comparison Between Quadro-iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block for Lumbar Stabilization Surgery: a Randomized Controlled Trial

This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the erector spinae plane block (ESPB) in patients undergoing lumbar stabilization surgery. The primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, incidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block-related complications (hematoma, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Materials and Methods:

This prospective, randomized clinical trial will include patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective primary lumbar stabilization surgery under general anesthesia. Before enrollment, all patients will be informed about the study protocol and written informed consent will be obtained. Patients will be instructed on the use of the Numeric Rating Scale (NRS) for postoperative pain assessment, where 0 represents no pain and 10 represents the worst pain imaginable.

Patients with contraindications to regional anesthesia, allergy to local anesthetics, coagulopathy, infection at the injection site, chronic opioid use, pre-existing neurological deficits involving the lower extremities, cognitive impairment preventing reliable communication, revision lumbar surgery, and refusal to participate will be excluded from the study.

Patients will be randomly allocated to one of two study groups using a computer-generated randomization sequence (https://www.randomizer.org). Randomization will be performed by a team member not involved in patient management or outcome assessment. Allocation concealment will be achieved using sequentially numbered sealed opaque envelopes, which will be opened immediately before block performance.

Upon arrival in the operating room, standard monitoring including electrocardiography, non-invasive blood pressure measurement, and pulse oximetry will be applied. Following intravenous access, general anesthesia will be induced using a standardized protocol consisting of propofol, fentanyl, and rocuronium to facilitate endotracheal intubation. Anesthesia will be maintained with sevoflurane or desflurane in an oxygen/air mixture, titrated to maintain hemodynamic stability within 20% of baseline values.

Following the induction of general anesthesia and prior to surgical incision, patients will receive either ultrasound-guided quadro-iliac plane block (QIPB) or ultrasound-guided erector spinae plane block (ESPB) according to group allocation. All blocks will be performed by anesthesiologists experienced in regional anesthesia and familiar with both techniques.

All patients will receive the same multimodal postoperative analgesic regimen and standardized postoperative rehabilitation protocol. Postoperative pain scores at rest and during movement will be assessed using the NRS during the first 48 postoperative hours. Opioid consumption, incidence of quadriceps motor block, time to first ambulation, patient satisfaction, postoperative nausea and vomiting, falls, length of hospital stay, block performance time, and block-related complications will also be recorded.

Outcome assessments will be performed by investigators who are unaware of group allocation.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

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

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
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-III
  • Scheduled for elective primary lumbar stabilization surgery
  • Surgery planned under general anesthesia
  • Ability to understand and use the Numeric Rating Scale
  • Written informed consent provided

Exclusion Criteria:

  • Refusal to participate
  • Revision lumbar stabilization surgery
  • Contraindication to regional anesthesia
  • Contraindication to peripheral nerve/plane block
  • Known allergy to local anesthetics or study drugs
  • Coagulopathy or anticoagulant use incompatible with neuraxial/regional -anesthesia
  • Infection at the block injection site
  • Pre-existing neurological deficit involving the lower extremities (unrelated to t-he current spinal pathology)
  • Peripheral neuropathy
  • Chronic opioid use
  • Cognitive impairment or inability to communicate reliably
  • Severe hepatic or renal failure
  • Body mass index > 35 kg/m2
  • Pregnancy

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: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: quadro-iliac plane block (QIPB)
Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after the induction of general anesthesia. Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.
Procedura: Quadro iliac Plane Block
Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after the induction of general anesthesia. Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.
Comparatore attivo: Erector Spina Plane Block
Participants in the ESPB group will undergo an ultrasound-guided erector spinae plane block after the induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.
Procedura: Quadro iliac Plane Block
Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after the induction of general anesthesia. Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative pain scores
Lasso di tempo: 6,24,36,48 hours
Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores at rest will be recorded in the post-anesthesia care unit and at postoperative 6, 24, 36, and 48 hours. Pain scores during movement will be assessed during passive flexion of the operated hip at postoperative 6, 24, 36, and 48 hours.
6,24,36,48 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of quadriceps motor block
Lasso di tempo: Postoperative 3, 6, and 24 hours

Quadriceps motor block will be assessed using knee extension testing and graded as:

0 = normal strength

  1. = paresis
  2. = paralysis. Motor block incidence will be defined as the presence of paresis or paralysis.
Postoperative 3, 6, and 24 hours
Patient satisfaction
Lasso di tempo: Postoperative 48 hours
Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.
Postoperative 48 hours
Postoperative nausea and vomiting (PONV)
Lasso di tempo: Postoperative 48 hours
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
Postoperative 48 hours
Falls
Lasso di tempo: Through postoperative day 2
Incidence of falls during the first 48 postoperative hours.
Through postoperative day 2
Length of hospital stay
Lasso di tempo: Through hospital discharge, up to 30 days
Number of days from surgery to hospital discharge.
Through hospital discharge, up to 30 days
Time to first ambulation
Lasso di tempo: Postoperative day 1
Time from the end of surgery to the first successful ambulation.
Postoperative day 1
Block performance time
Lasso di tempo: Periprocedural
Time from ultrasound probe placement to completion of local anesthetic injection.
Periprocedural
Block-related complications
Lasso di tempo: Through hospital discharge, up to 30 days
Hematoma Vascular puncture Local anesthetic systemic toxicity (LAST) Infection at the injection site
Through hospital discharge, up to 30 days
Postoperative opioid consumption
Lasso di tempo: postoperative 24 and 48 hours
Total postoperative opioid consumption will be recorded and cumulative opioid consumption will be calculated at postoperative 24 and 48 hours.
postoperative 24 and 48 hours

Collaboratori e investigatori

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

Sponsor

Antalya City Hospital

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)

15 novembre 2026

Completamento primario (Stimato)

15 agosto 2027

Completamento dello studio (Stimato)

15 settembre 2027

Date di iscrizione allo studio

Primo inviato

1 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 agosto 2026

Primo Inserito (Effettivo)

27 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 agosto 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • QİPBvsESP

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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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