ESP Block Vs. QIPB for Lumbar Stabilization Surgery
Comparison Between Quadro-iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block for Lumbar Stabilization Surgery: a Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Damla Kaytancı Özçelik, MD
- Telefonní číslo: +905075124445
- E-mail: damla.kaytanci@saglik.gov.tr
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
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.
|
|
Aktivní komparátor: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative pain scores
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of quadriceps motor block
Časové okno: Postoperative 3, 6, and 24 hours
|
Quadriceps motor block will be assessed using knee extension testing and graded as: 0 = normal strength
|
Postoperative 3, 6, and 24 hours
|
|
Patient satisfaction
Časové okno: Postoperative 48 hours
|
Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.
|
Postoperative 48 hours
|
|
Postoperative nausea and vomiting (PONV)
Časové okno: Postoperative 48 hours
|
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
|
Postoperative 48 hours
|
|
Falls
Časové okno: Through postoperative day 2
|
Incidence of falls during the first 48 postoperative hours.
|
Through postoperative day 2
|
|
Length of hospital stay
Časové okno: 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
Časové okno: Postoperative day 1
|
Time from the end of surgery to the first successful ambulation.
|
Postoperative day 1
|
|
Block performance time
Časové okno: Periprocedural
|
Time from ultrasound probe placement to completion of local anesthetic injection.
|
Periprocedural
|
|
Block-related complications
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- QİPBvsESP
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