- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Tanta, Egypten
- Tanta University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
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.
|
|
Experimentell: 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.
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Proportion of patients needing rescue analgesia
Tidsram: within the first 24 postoperative hours.
|
within the first 24 postoperative hours.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analogue Scale
Tidsram: 24 postoperative hours
|
Visual Analogue Scale pain intensity measurements.
|
24 postoperative hours
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 36264MS975/6/25
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
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