- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07850596
Quadratus Lumborum Block, Transversus Abdominis Plane Block, and Erector Spinae Block in Pediatric Abdominal Surgery
Comparing Quadratus Lumborum Block, Transversus Abdominis Plane Block, and Erector Spinae Block in Pediatric Abdominal Surgery
The aim of this study is to compare the analgesic efficacy and safety of Quadratus Lumborum (QL), Transversus Abdominis Plane (TAP), and Erector Spinae Plane (ESP) blocks in pediatric abdominal surgery.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Advances in perioperative care of children continue to be made with increasing evidence-based practice for postoperative analgesia. However, moderate to severe pain is still experienced by up to 40% of hospitalized children and specific high-risk populations or types of surgery continue to present challenges.
Transversus abdominis plane (TAP) block involves the injection of local anesthesia (LA) in between the transversus abdominis (TA) and internal oblique (IO) muscles.
The Erector Spinae Plane (ESP) block is most often performed using an in-plane ultrasound-guided technique. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Menoufia
-
Shibīn al Kawm, Menoufia, Egypten, 32951
- Menoufia University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Children aged from 3 to12 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Scheduled for pediatric abdominal surgery.
Exclusion Criteria:
- Allergy or contraindication to bupivacaine or dexmedetomidine.
- Coagulopathy.
- Local infection at the site of the block.
- Neurological or psychiatric disorders affecting pain perception.
- Refusal of the regional technique by parents/guardians.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: QL Group
Patients received quadratus lumborum (QL) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg. |
Patients received quadratus lumborum (QL) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
Andra namn:
|
|
Experimentell: TAP group
Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg |
Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
Andra namn:
|
|
Experimentell: ES Group
Patients received erector spinae plane (ESP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg. |
Patients received erector spinae plane (ESP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Degree of pain
Tidsram: 24 hours postoperatively
|
Degree of pain will be assessed using Wong-Baker FACES for the first 24 hours postoperative at 4, 8,12,16 and 24 hours postoperatively. Wong-Baker FACES Pain Scale, which utilizes a series of 6 faces increasing in pain severity may be used to facilitate communication and assist in pain assessment . |
24 hours postoperatively
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total fentanyl consumption
Tidsram: Intraoperatively
|
If patient require analgesia during surgery (diagnosed by increasing heart rate and blood pressure) fentanyl 1mic/kg will be given, and total analgesic consumption will be calculated and recorded. |
Intraoperatively
|
|
Heart rate
Tidsram: Till the end of surgery (Up to 2 hours)
|
Heart rate will be recorded every 15 minutes till the end of surgery. |
Till the end of surgery (Up to 2 hours)
|
|
Mean arterial blood pressure
Tidsram: Till the end of surgery (Up to 2 hours)
|
Mean arterial blood pressure will be recorded every 15 minutes till the end of surgery. |
Till the end of surgery (Up to 2 hours)
|
|
Time of each block
Tidsram: Intraoperatively
|
Time of each block will be recorded from using ultrasound probe till injection of local anaesthetic |
Intraoperatively
|
|
Sedation score
Tidsram: 24 hours postoperatively
|
Sedation score will be recorded at 0, 15 min ,30 min postoperative 0=no sedation (wide awake). =slightly sedated (easy to arouse) 2=moderately sedated(easy to arouse but cannot stay awake) 3=heavy sedated (difficult to arouse) |
24 hours postoperatively
|
|
Time to first rescue analgesia
Tidsram: 24 hours postoperatively
|
Time to first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated. |
24 hours postoperatively
|
|
Total morphine consumption
Tidsram: 24 hours postoperatively
|
If the pain score more than or equal to 4), opioid (morphine) 0.5 to 1 mg/kg will be given and total dose will be calculated |
24 hours postoperatively
|
|
Incidence of postoperative complications
Tidsram: 24 hours postoperatively
|
Incidence of postoperative complications such as hypotension, nausea and vomiting will be recorded. |
24 hours postoperatively
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
Ytterligare relevanta MeSH-villkor
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Azoler
- Imidazoler
- Anilider
- Amider
- Anilinföreningar
- Aminer
- Beteendediscipliner och aktiviteter
- Matsmältningssystem och orala fysiologiska fenomen
- Beteendevetenskap
- Tandläkare
- Tandfysiologiska fenomen
- Bupivakain
- Dexmedetomidin
- Tandvård
- Parapsykologi
Andra studie-ID-nummer
- 12/2024 ANET 32
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Tidsram för IPD-delning
After the end of study for one year.
Kriterier för IPD Sharing Access
The data will be available upon a reasonable request from the corresponding author.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
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