The Quadro-Iliac Plane (QIP) Block in Hip Surgery (QIP in hip)
The Effectiveness of the "Quadro-Iliac Plane Block" in Hip Surgery: A Prospective Observational Clinical Study
The goal of this observational study is to learn about the effectiveness of different locoregional anesthesia techniques, particularly the Quadro-Iliac Plane (QIP) block, in patients undergoing hip surgery, including arthroplasty. The main question it aims to answer is:
Does the QIP block improve postoperative recovery and pain control compared to other routinely used locoregional anesthesia techniques in patients undergoing hip surgery?
Participants undergoing hip surgery as part of their standard clinical care will receive one of the locoregional anesthesia techniques already in use at the hospital (including QIP block, fascia iliaca block, PENG block, or others, according to anesthesiologist choice). Postoperative outcomes will be collected prospectively, including quality of recovery (QoR-15 at 24 hours), pain scores at rest and during movement at predefined time points up to 48 hours, analgesic consumption, time to first analgesic request, time to mobilization, and occurrence of complications.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This prospective, observational, non-interventional clinical study will evaluate postoperative recovery and analgesic outcomes in adult patients undergoing hip surgery who receive locoregional anesthesia techniques already used in routine clinical practice.
The study focuses particularly on the Quadro-Iliac Plane (QIP) block, a recently introduced fascial plane block performed at the posterior-inferior aspect of the quadratus lumborum muscle near its insertion on the iliac crest. The QIP block will be assessed in comparison with other locoregional techniques routinely used for hip surgery, including fascia iliaca block, PENG block, sacral or lumbosacral erector spinae plane block, femoral nerve block, sciatic nerve block, lumbar plexus block, neuraxial anesthesia, or combinations of these techniques.
Patients will not be randomized, and the choice of anesthetic and analgesic technique will be made by the attending anesthesiologist according to standard clinical practice. All blocks will be ultrasound-guided and performed under aseptic conditions using approved local anesthetics. Standard perioperative monitoring, spinal anesthesia when appropriate, postoperative multimodal analgesia, and rescue analgesia will be provided according to institutional protocols.
The primary endpoint will be postoperative quality of recovery, assessed using the Quality of Recovery-15 score 24 hours after surgery. Secondary outcomes will include postoperative pain scores at rest and during movement at predefined time points up to 48 hours, patient satisfaction, total analgesic consumption, time to first rescue analgesic request, time to first mobilization, nausea and vomiting, antiemetic use, and block-related or postoperative adverse events. Safety monitoring will include immediate complications during block performance, early post-block complications, and delayed neurological symptoms assessed up to 7 days after surgery.
The study plans to include at least 40 patients, with a possible sample size of 40-80 cases, and an expected maximum study duration of 18 months.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Tommaso Sorrentino, MD
- Telefonní číslo: +393277038017
- E-mail: dr.sorrentinotommaso@gmail.com
Studijní místa
-
-
-
Crotone, Itálie
- Nábor
- Crotone Hospital
-
Kontakt:
- Tommaso Sorrentino
- Telefonní číslo: +393277038017
- E-mail: dr.sorrentinotommaso@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Age ≥ 18 years
- Patients undergoing hip surgery, either elective or for a proximal femoral fracture
- Expected postoperative hospital stay ≥ 24 hours
- ASA physical status I-III
- Neuraxial and/or locoregional anesthesia according to standard clinical practice
- Provision of informed consent to participate in the study
Exclusion Criteria:
- Absence of informed consent
- Contraindications to locoregional and/or spinal anesthesia
- Allergy to local anesthetic agents
- Cognitive impairment preventing reliable assessment of outcomes
- Coagulation disorders and/or platelet abnormalities
- Antiplatelet or anticoagulant therapy that contraindicates spinal anesthesia
- Presence of localized infection or sepsis at the sites to be treated
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
QIP
Quadro-Iliac Plane Block
|
Fascia Iliaca Block
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quality of Recovery (QoR)-15 score
Časové okno: 24 hours postoperatively
|
The Quality of Recovery-15 (QoR-15) is a validated patient-reported outcome measure designed to assess the quality of postoperative recovery across multiple dimensions of physical and psychological well-being. The questionnaire consists of 15 items, each scored on an 11-point numerical scale, resulting in a total score ranging from: Minimum score: 0 → extremely poor quality of recovery Maximum score: 150 → excellent quality of recovery Higher QoR-15 scores indicate a better postoperative recovery experience. The questionnaire evaluates five key domains: Pain Physical comfort Physical independence Psychological support Emotional state |
24 hours postoperatively
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Complications
Časové okno: up to 48 hours
|
Toxicity, PONV, others
|
up to 48 hours
|
|
Postoperative Pain
Časové okno: 0-2-4-6-8-12-24-48 hours after surgery
|
The Numerical Rating Scale (NRS) is a validated and widely used tool for the assessment of pain intensity in clinical practice and perioperative research. Patients are asked to rate their pain on a numerical scale ranging from: 0 → no pain 10 → worst pain imaginable |
0-2-4-6-8-12-24-48 hours after surgery
|
|
First analgesia request
Časové okno: up to 48 hours
|
Duration of analgesia
|
up to 48 hours
|
|
First mobilization
Časové okno: 24 hours postoperatively
|
First mobilization of the patient after surgery
|
24 hours postoperatively
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
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
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- QIP_study
- No other (Jiný identifikátor: Crotone Hospital)
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