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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Damla Kaytancı Özçelik, MD
- Numer telefonu: +905075124445
- E-mail: damla.kaytanci@saglik.gov.tr
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny 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.
|
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.
|
|
Aktywny 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.
|
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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative pain scores
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of quadriceps motor block
Ramy czasowe: 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
Ramy czasowe: Postoperative 48 hours
|
Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.
|
Postoperative 48 hours
|
|
Postoperative nausea and vomiting (PONV)
Ramy czasowe: Postoperative 48 hours
|
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
|
Postoperative 48 hours
|
|
Falls
Ramy czasowe: Through postoperative day 2
|
Incidence of falls during the first 48 postoperative hours.
|
Through postoperative day 2
|
|
Length of hospital stay
Ramy czasowe: 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
Ramy czasowe: Postoperative day 1
|
Time from the end of surgery to the first successful ambulation.
|
Postoperative day 1
|
|
Block performance time
Ramy czasowe: Periprocedural
|
Time from ultrasound probe placement to completion of local anesthetic injection.
|
Periprocedural
|
|
Block-related complications
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- QİPBvsESP
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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