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ESP Block Vs. QIPB for Lumbar Stabilization Surgery

24. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

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:

  • 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

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Fremgangsmåte: 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.
Aktiv komparator: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative pain scores
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of quadriceps motor block
Tidsramme: 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
Tidsramme: Postoperative 48 hours
Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.
Postoperative 48 hours
Postoperative nausea and vomiting (PONV)
Tidsramme: Postoperative 48 hours
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
Postoperative 48 hours
Falls
Tidsramme: Through postoperative day 2
Incidence of falls during the first 48 postoperative hours.
Through postoperative day 2
Length of hospital stay
Tidsramme: 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
Tidsramme: Postoperative day 1
Time from the end of surgery to the first successful ambulation.
Postoperative day 1
Block performance time
Tidsramme: Periprocedural
Time from ultrasound probe placement to completion of local anesthetic injection.
Periprocedural
Block-related complications
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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

Sponsor

Antalya 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 (Antatt)

15. november 2026

Primær fullføring (Antatt)

15. august 2027

Studiet fullført (Antatt)

15. september 2027

Datoer for studieregistrering

Først innsendt

1. juli 2026

Først innsendt som oppfylte QC-kriteriene

24. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • QİPBvsESP

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