- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07618650
Ultrasound-Guided Transversalis Fascia Plane Block Versus Quadratus Lumborum Plane Block for Analgesia After Appendectomy in Pediatrics
Ultrasound-Guided Transversalis Fascia Plane Block Versus Quadratus Lumborum Plane Block for Analgesia After Appendectomy in Pediatrics: A Prospective Randomized Study
This study aims to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy.
Primary outcomes:
• Proportion of patients needing rescue analgesia within the first 24 postoperative hours.
Secondary outcomes:
- Visual Analogue Scale pain intensity measurements.
- Intraoperative Heart rate and mean arterial blood pressure will be recorded.
- Time to first analgesic request for patients needing rescue analgesia (Fentanyl).
- Block-related complications (e.g., hematoma, local anesthetic toxicity, lower limb weakness).
- Parents' satisfaction score.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Appendicectomy is amongst the most commonly performed surgery, with acute appendicitis being the most frequent reason for abdominal surgical emergencies in the world . The lifetime risk of appendicitis is 7-8%, with rising incidence in the newly industrialized countries . The prevailing treatment of choice for appendicitis is appendicectomy, which can be performed either 'open' or laparoscopically .
A major contributor to the pain experienced by a patient after abdominal surgery is the incision made in the abdominal wall . Almost 80% of patients undergoing surgery experience postoperative pain, and 80% of them reported moderate-to-severe pain intensity .
Traditional methods of postoperative pain management in children, such as systemic opioids and nonsteroidal anti-inflammatory drugs , may not always provide adequate relief, especially for more invasive procedures . These approaches can also be associated with side effects like sedation, nausea, and respiratory depression, which may complicate postoperative care and recovery . In recent years, regional anesthesia techniques have emerged as promising alternatives for postoperative pain management in various surgical populations Two specific regional blocks that have gained attention for their potential benefits in reducing postoperative pain after abdominal surgeries is the Quadratus Lumborum Block and the Transversus Facial Abdominal Plane block The Quadratus Lumborum Block targets the nerves supplying the lumbar plexus, providing analgesia to the anterior abdominal wall . It has been shown to be effective in adult patients undergoing lower abdominal surgery, offering improved postoperative pain scores and reduced opioid consumption compared to traditional pain management strategies .
Although, both Quadratus Lumborum Block and Transversus Facial Abdominal Plane block are frequently employed in pediatric anesthesia, evidence to guide clinical decisions on which block offers superior outcomes needs to be comprehensively reviewed. We aimed to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy.
This study aims to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy.
Primary outcomes:
• Proportion of patients needing rescue analgesia within the first 24 postoperative hours.
Secondary outcomes:
- Visual Analogue Scale pain intensity measurements.
- Intraoperative Heart rate and mean arterial blood pressure will be recorded.
- Time to first analgesic request for patients needing rescue analgesia (Fentanyl).
- Block-related complications (e.g., hematoma, local anesthetic toxicity, lower limb weakness).
- Parents' satisfaction score.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Tanta, Egypten
- Tanta University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 70 patients aged between 7 and 12 years of both sexes undergoing appendectomy, American Society of Anesthesiologists (ASA) physical status of I or II
Exclusion Criteria:
- Refusal of parents to participate
- Patients with peritonitis
- History of allergy to bupivacaine and other amide local anesthetics
- Infection at the site of block needle entry
- Bleeding diathesis
- Neurological disorders
- American Society of Anesthesiologists ≥ III
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group I: Transversalis Fascia Plane Block versus
Patients will receive general anesthesia and ultrasound-guided transversalis fascia plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision
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35 Patients will receive general anesthesia and ultrasound-guided transversalis fascia plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision.
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Eksperimentel: Group II :Quadratus Lumborum Plane Block
patients will receive general anesthesia and a quadratus lumborum plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision.
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35 patients will receive general anesthesia and a quadratus lumborum plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Proportion of patients needing rescue analgesia
Tidsramme: within the first 24 postoperative hours.
|
within the first 24 postoperative hours.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Analogue Scale
Tidsramme: 24 postoperative hours
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Visual Analogue Scale pain intensity measurements.
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24 postoperative hours
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 36264MS975/6/25
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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Kliniske forsøg med Quadratus Lumborum blok
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The General Authority for Teaching Hospitals and...AfsluttetKejsersnit | Quadratus Lumborum blok | Transversus Abdominis Plane BlockEgypten
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Port Said University hospitalAfsluttetErector Spinae Plane Block | Quadratus Lumborum blok | Sleeve GastrectomyEgypten
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Zagazig UniversityAfsluttetLaparoskopisk kolecystektomi | Erector Spinae Plane Block | Quadratus Lumborum blokEgypten
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Tanta UniversityIkke rekrutterer endnuLaparoskopisk kolecystektomi | Erector Spinae Plane Block | Quadratus Lumborum blok | Postoperativ analgesi
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Kafrelsheikh UniversityAfsluttetAnalgesi | Erector Spinae Plane Block | Quadratus Lumborum blok | Paravertebral blokEgypten
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Ankara City Hospital BilkentAfsluttetQuadratus Lumborum blok | Opioidforbrug | Postprocedurel analgesi | Erector Spina Plan BlockKalkun
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Fayoum University HospitalAfsluttetQuadratus Lumborum Block og Rectus Sheath BlockEgypten
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Tanta UniversityRekrutteringQuadratus Lumborum blokEgypten
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Assiut UniversityRekrutteringQuadratus Lumborum blokEgypten
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Ostfold Hospital TrustAfsluttetQuadratus Lumborum blok | KolecystektomiNorge
Kliniske forsøg med Transversalis Fascia Plane Block group
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Samsun UniversityAfsluttetKejsersnit | Akut smertebehandlingKalkun
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Zonguldak Bulent Ecevit UniversityAktiv, ikke rekrutterendeSmerter, postoperativ | Regional anæstesi | ForældretilfredshedKalkun
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Kocaeli UniversityAfsluttetPostoperativ analgesiKalkun
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Muğla Sıtkı Koçman UniversityIkke rekrutterer endnuMavesmerter | Kejsersnit | Postoperativ restitutionKalkun
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Tanta UniversityAfsluttetBørn | Caudal blok | Ultralyd | Postoperativ analgesi | Lyskebrok | Transversalis Fascia Plane BlockEgypten
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Ataturk UniversityAfsluttetAnalgesi | Transversalis Fascia Plane Block | Sår infiltration | VaricoselektomiKalkun
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Maltepe UniversityAfsluttet
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Second Affiliated Hospital of Wenzhou Medical UniversityBeijing Jishuitan HospitalAfsluttetUdviklingsdysplasi i hoften (DDH)Kina
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Istanbul Training and Research HospitalRekrutteringBrok, lyskebrokKalkun
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Tanta UniversityRekrutteringTransversalis fascia -planblok mod intratekal dexmedetomidin hos patienter, der gennemgår kejsersnitKejsersnit | Transversalis Fascia Plane Block | Intratekal dexmedetomidinEgypten