- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07720817
Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block in Laparoscopic Upper Abdominal Surgeries
Safety and Efficacy of Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block on Quality of Recovery in Laparoscopic Upper Abdominal Surgeries: A Randomized Comparative Clinical Trial
Přehled studie
Postavení
Detailní popis
Laparoscopic surgery is now a widely accepted practice, offering several advantages, including better cosmetic outcomes, increased patient satisfaction, and shorter hospital stays . The complexity and range of procedures performed laparoscopically have grown significantly, now including complex operations like cholecystectomy, nephrectomy, hernia repair, and an increasing number of emergency surgeries .
Despite these benefits, postoperative pain following laparoscopic procedures, such as cholecystectomy, can be substantial and hinder recovery . This pain may negatively affect respiratory function, delay ambulation, and ultimately prolong their hospital stay. Historically, pain management has often relied on high doses of narcotics, which may lead to complications like dizziness, respiratory depression, and postoperative nausea and vomiting (PONV) . These drawbacks have spurred the search for alternative and improved pain relief strategies .
Ultrasound-guided nerve blocks have become an essential component of multimodal postoperative analgesia due to their effectiveness, precision, and safety profile . One of such techniques is the Transversus Abdominis Plane (TAP) block, which is used as part of a comprehensive strategy to optimize postoperative pain control. Local anesthetic is injected into the neurovascular plane of the abdominal wall . The TAP block works by providing sensory blockade to the spinal nerves that run between the internal oblique and transverse abdominis muscles. The anesthetic infiltration affects the thoracic intercostal nerves, the ilioinguinal and iliohypogastric nerves, and the lateral cutaneous branches of the lumbar nerves.
Another important technique is the Retrolaminar Block (RLB), introduced in 2006 as a simpler alternative to the thoracic paravertebral block (TPVB) . The RLB is less invasive because it targets the bony vertebral lamina, unlike the TPVB, which requires puncturing the superior costotransverse ligament . The procedure involves injecting a local anesthetic (LA) into the fascial plane located between the posterior thoracic lamina and the overlying transversus spinae muscles allowing spread of the local anesthetic to the thoracic paravertebral and epidural spaces, thus the blockade of the dorsal branch of the spinal nerves that cross the retrolaminar plane .Studies, including cadaveric models, have confirmed that the anesthetic injected during an RLB spreads through the intertransverse ligaments into the paravertebral and epidural spaces, effectively numbing 2-4 spinal segments . For instance, a 2022 clinical trial showed that ultrasound-guided RLBs significantly reduced opioid consumption in patients recovering from laparoscopic cholecystectomy compared to conventional pain management , highlighting its potential as a safe and effective option.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: mohamed elnagar Mohamed A. Elnagar MB BCh, MB BCh
- Telefonní číslo: +20 1009344804
- E-mail: melnaggar789@gmail.com
Studijní místa
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypt
- Mansoura University
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Kontakt:
- mohamed a Mohamed A. Elnagar MB BCh, MB BCh
- Telefonní číslo: +20 1009344804
- E-mail: melnaggar789@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age between 21 and 65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Body mass index (BMI) less than 30 kg/m².
- Scheduled for elective laparoscopic upper abdominal surgery under general anesthesia.
Exclusion Criteria:
- Refusal to participate in the study.
- Known allergy or hypersensitivity to any of the study drugs.
- Infection at the planned block insertion site.
- Severe uncontrolled cardiac, renal, hepatic, neurological, or respiratory disease.
- Pre-existing chronic pain.
- Immunodeficiency.
- Coagulation abnormalities, anticoagulant therapy, or platelet count less than 80,000/µL.
- Emergency surgery.
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 |
|---|---|
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Experimentální: Retrolaminar Block Group
Patients will receive an ultrasound-guided retrolaminar block using 20 ml of 0.25% of bupivacaine administered at the T7 level at both sides
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Ultrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.
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Aktivní komparátor: Transverses Abdominis Plane (TAP) Block Group
Patients will receive an ultrasound-guided TAP block using 20 ml of 0.25% bupivacaine at both sids
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Ultrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The postoperative Quality of Recovery-15 score
Časové okno: 24 hour postoperative
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The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 items.
The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
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24 hour postoperative
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Numeric Rating Scale (NRS) at rest and during coughing
Časové okno: Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
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Postoperative pain intensity at rest and during coughing will be assessed using the Numeric Rating Scale (NRS).
The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain .
Higher scores indicate greater pain intensity (worse outcome).
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Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
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Total dose of rescue analgesics administered (mg) within the first 24 hours after surgery
Časové okno: From the end of surgery to 24 hours after surgery.
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The cumulative dose of rescue postoperative analgesics administered to each participant during the first 24 hours after surgery will be recorded.
Higher values indicate greater postoperative analgesic requirements.
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From the end of surgery to 24 hours after surgery.
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Time to first postoperative opioid analgesic request (hours)
Časové okno: From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
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Time from the end of surgery until the first postoperative request for opioid analgesia
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From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
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Duration of hospital stay
Časové okno: From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
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Duration of hospital stay, measured as the number of days from the date of surgery until hospital discharge.
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From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
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Mean intraoperative mean arterial pressure (mmHg)
Časové okno: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
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Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be recorded during surgery
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At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
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Mean intraoperative heart rate (beats/min)
Časové okno: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
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Heart rate (HR), measured in beats per minute (beats/min), will be recorded during surgery
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At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
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Mean intraoperative peripheral oxygen saturation (%)
Časové okno: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
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Peripheral oxygen saturation (SpO₂), measured as percentage (%), will be recorded during surgery
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At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
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Number of participants with postoperative nausea
Časové okno: From the end of surgery to 24 hours after surgery
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Number of participants who experienced postoperative nausea
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From the end of surgery to 24 hours after surgery
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Number of participants with postoperative vomiting
Časové okno: From the end of surgery to 24 hours after surgery
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Number of participants who experienced postoperative vomiting
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From the end of surgery to 24 hours after surgery
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Number of participants with postoperative shivering
Časové okno: From the end of surgery to 24 hours after surgery
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Number of participants who experienced postoperative shivering
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From the end of surgery to 24 hours after surgery
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Number of participants with postoperative hypotension
Časové okno: From the end of surgery to 24 hours after surgery
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Number of participants who experienced postoperative hypotension
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From the end of surgery to 24 hours after surgery
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Number of participants with postoperative bradycardia
Časové okno: From the end of surgery to 24 hours after surgery
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Number of participants who experienced postoperative bradycardia
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From the end of surgery to 24 hours after surgery
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Number of participants with postoperative headache
Časové okno: From the end of surgery to 24 hours after surgery
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Number of participants who experienced postoperative headache
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From the end of surgery to 24 hours after surgery
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Total intraoperative ephedrine dose administered (mg)
Časové okno: From induction of anesthesia until the end of surgery
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The cumulative dose of ephedrine administered intraoperatively for the treatment of hypotension, measured in milligrams (mg).
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From induction of anesthesia until the end of surgery
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Number of participants requiring intraoperative ephedrine administration
Časové okno: From induction of anesthesia until the end of surgery
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Number of participants who required ephedrine administration for the treatment of intraoperative hypotension.
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From induction of anesthesia until the end of surgery
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: hatem saber mohamed ali, Professor, Faculty of Medicine, Mansoura University
- Studijní židle: Naglaa A Elnegeery, Associate Professor, Faculty of Medicine, Mansoura University
- Ředitel studie: Ola Shawky Naguib El Nagar, Lecturer, Faculty of Medicine, Mansoura University
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 identifikační čísla studie
- Retrolamianr and TAP blocks
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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