- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07787221
QL Block Versus EO Plane Block for Analgesia After Open Nephrectomy
Quadratus Lumborum Block Versus External Oblique Plane Block for Analgesia After Open Nephrectomy: A Prospective Randomized Clinical Trial
This prospective randomized clinical trial aims to compare two ultrasound-guided regional anesthesia techniques, the transmuscular quadratus lumborum (QL) block and the external oblique (EO) plane block, for pain relief after open nephrectomy. Open nephrectomy is a major surgical procedure that can cause significant postoperative pain and may require opioid medications for adequate pain control.
Adult patients undergoing open nephrectomy at the National Cancer Institute, Cairo University, who meet the study eligibility criteria will be randomly assigned to receive either a QL block or an EO plane block before surgery. Both techniques will be performed under ultrasound guidance using bupivacaine in addition to standardized general anesthesia and multimodal postoperative analgesia.
The main purpose of the study is to determine whether the QL block provides better postoperative analgesia than the EO plane block. The primary outcome will be the total amount of intravenous morphine consumed during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, time to first request for rescue analgesia, hemodynamic changes, recovery time, patient satisfaction, and adverse effects related to analgesia or the regional anesthesia techniques.
A total of 54 patients will be enrolled and randomly allocated equally between the two treatment groups.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The study is a prospective, randomized clinical trial designed to compare the analgesic efficacy of the transmuscular quadratus lumborum block with the external oblique plane block in adult patients undergoing open nephrectomy.
Open nephrectomy is associated with substantial postoperative pain because of the extent of the surgical incision, muscular dissection, and manipulation of retroperitoneal structures. Effective postoperative analgesia is important to facilitate recovery, mobilization, respiratory function, and patient comfort while minimizing opioid requirements.
The quadratus lumborum block is a posterior abdominal wall fascial plane block in which local anesthetic is deposited in relation to the quadratus lumborum muscle. The technique may provide analgesia over several thoracoabdominal dermatomes and may have both somatic and visceral analgesic effects. The external oblique plane block is a more superficial fascial plane technique that targets the lateral abdominal wall and may provide effective somatic analgesia.
Eligible patients will be randomly allocated in a 1:1 ratio to receive either a transmuscular QL block or an EO plane block before induction of general anesthesia. All patients will receive standardized general anesthesia and multimodal postoperative analgesia. The regional blocks will be performed under ultrasound guidance by an experienced anesthesiologist.
The primary outcome is total intravenous morphine consumption during the first 24 postoperative hours. Secondary outcomes include pain intensity at predefined postoperative time points, both at rest and with movement; time to first request for rescue analgesia; intraoperative and postoperative hemodynamic changes; recovery time; patient satisfaction; and adverse effects, including nausea, vomiting, respiratory depression, and complications related to the regional anesthesia technique.
The study will evaluate whether the QL block provides superior postoperative analgesia and opioid-sparing effects compared with the EO plane block following open nephrectomy.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: sayed M Abed, MD
- Telefonní číslo: 002-01226806532
- E-mail: sayed.abed@nci.cu.edu.eg
Studijní záloha kontaktů
- Jméno: Nourhan R Ali Hassan, Master's
- Telefonní číslo: 002-01200858194
- E-mail: nourhanrabeaali@gmail.com
Studijní místa
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-
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Cairo, Egypt
- Nábor
- Cairo University
-
Kontakt:
- sayed M Abed, MD
- Telefonní číslo: 002-01226806532
- E-mail: sayed.abed@nci.cu.edu.eg
-
Kontakt:
- Nourhan R Ali Hassan, Master's
- Telefonní číslo: 002-01200858194
- E-mail: nourhanrabeaali@gmail.com
-
Cairo, Egypt, 11796
- Nábor
- Cairo University
-
Kontakt:
- sayed M Abed, MD
- Telefonní číslo: 002-01226806532
- E-mail: sayed.abed@nci.cu.edu.eg
-
Kontakt:
- Nourhan R Ali Hassan, Master's
- Telefonní číslo: 002-01200858194
- E-mail: nourhanrabeaali@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
**Inclusion Criteria:**
- Adult patients aged 18 to 65 years.
- Patients undergoing open nephrectomy at the National Cancer Institute, Cairo University.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Body mass index (BMI) greater than 20 kg/m² and less than 35 kg/m².
**Exclusion Criteria:**
- Patient refusal to participate.
- ASA physical status IV.
- Age less than 18 years or greater than 65 years.
- BMI less than 20 kg/m² or greater than 35 kg/m².
- Known allergy or contraindication to any study medication, including local anesthetics or opioids.
- History of psychiatric disorders or chronic pain.
- Contraindications to regional anesthesia, including local infection at the injection site, pre-existing neuropathy, or coagulopathy.
- Severe organ dysfunction, including cardiac dysfunction (ejection fraction <40%), respiratory dysfunction (FEV1 <50% of predicted or requirement for home oxygen therapy), hepatic dysfunction (Child-Pugh class C), or renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Quadratus Lumborum Block (QL)
Participants will receive an ultrasound-guided transmuscular quadratus lumborum block before induction of general anesthesia.
A total of 30 mL of 0.25% bupivacaine will be administered in the fascial plane between the quadratus lumborum and psoas major muscles.
Participants will also receive the standardized general anesthesia and postoperative multimodal analgesia described in the study protoco
|
Ultrasound-guided transmuscular quadratus lumborum block using 30 mL of 0.25% bupivacaine administered before induction of general anesthesia.
|
|
Experimentální: External Oblique Plane Block (EO)
Participants will receive an ultrasound-guided external oblique plane block before induction of general anesthesia.
A total of 30 mL of 0.25% bupivacaine will be administered in the fascial plane between the external oblique and intercostal muscles.
Participants will also receive the standardized general anesthesia and postoperative multimodal analgesia described in the study protocol.
|
Ultrasound-guided external oblique plane block using 30 mL of 0.25% bupivacaine administered before induction of general anesthesia.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
24-hour postoperative morphine consumption
Časové okno: First 24 hours after surgery
|
Total amount of intravenous morphine administered as rescue analgesia during the first 24 hours after surgery.
Morphine consumption will be recorded for each participant and compared between the quadratus lumborum block and external oblique plane block groups.
|
First 24 hours after surgery
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Mona H Abdelhamid, MD, Professor of anesthesia
Publikace a užitečné odkazy
Obecné publikace
- Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
- Blanco R. TAP block under ultrasound guidance: the description of a "non-pops technique." Reg Anesth Pain Med. 2007;32(2):130.
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
- QL block vs EOB in nephrectomy
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Popis plánu IPD
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