- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07617545
External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries
Ultrasound Guided External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Paediatric nerve blocks are increasingly recognized as new standard for managing pain in children. The advantages of regional anesthesia in this population include enhanced operating conditions, expedited recovery of bowel function, and reduced postoperative pain.
The caudal epidural block remains the most used method; however, the external oblique intercostal block, a novel technique involves administering local anesthesia deep to the external oblique muscle at the sixth intercostal space, thereby blocking thoracoabdominal nerves from T6 to T10. This technique offers several advantages, including straightforward anatomy, a single muscle strip that is easily identifiable even in obese patients, a bony backstop, and an easily expandable fascial plane that can accommodate a catheter.
The erector spinae plane block involves injecting local anesthetic into the fascial plane beneath the erector spinae muscle at the tip of the vertebral transverse process. This allows the local anesthetic to spread in the craniocaudal fascial plane.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Belal M Hassan, MBBCH
- Telefonnummer: 00201091397908
- E-post: Belal.bakr1420@alexmed.edu.eg
Studieorter
-
-
-
Alexandria, Egypten, 21526
- Rekrytering
- Alexandria University
-
Kontakt:
- Belal M Hassan, MBBCH
- Telefonnummer: 00201091397908
- E-post: Belal.bakr1420@alexmed.edu.eg
-
Underutredare:
- Wafaa M Shafshak, MD
-
Underutredare:
- Ola M Zanaty, MD
-
Underutredare:
- Mohamed W Nassar, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Children aged between 6 and 12 years of both sex.
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
- Patients undergoing upper abdominal surgeries involving upper abdominal incisions.
Exclusion Criteria:
- Guardian refusal.
- Allergy to local anesthetics.
- Surgical procedures exceeding 3 hours.
- Infection at the area planned for the block injection.
- Prolonged opioid medication.
- Patients preoperatively medicated by Beta blockers
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group I
Patients will receive ultrasound-guided external oblique intercostal plane block.
|
Patients will receive ultrasound-guided external oblique intercostal plane block.
|
|
Experimentell: Group II
Patients will receive ultrasound-guided erector spinae plane block.
|
Patients will receive ultrasound-guided erector spinae plane block.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Degree of pain
Tidsram: 12 hours after surgery
|
Postoperative pain will be assessed using Faces pain score revised. The Faces Pain Scale revised (FPS-R) is a validated self-report instrument designed to measure pain intensity in pediatric populations. The scale comprises a series of facial expressions, ranging from a smiling face at 0, indicating "no pain," to a crying face at 10, indicating "very much pain". Children are instructed to select the face that most accurately reflects their current pain level. The faces are scored (0, 2, 4, 6, 8, 10), providing a quantifiable measure of pain intensity. |
12 hours after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Heart rate
Tidsram: Every 15 minutes intraoperative
|
Heart rate will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Mean arterial blood pressure
Tidsram: Every 15 minutes intraoperative
|
Mean arterial blood pressure will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Peripheral oxygen saturation
Tidsram: Every 15 minutes intraoperative
|
Peripheral oxygen saturation will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Duration of analgesia
Tidsram: 12 hours after surgery
|
Duration of analgesia will be recorded from block completion till first postoperative rescue analgesia requirement.
|
12 hours after surgery
|
|
Total rescue analgesia requirement
Tidsram: 12 hours after surgery
|
In Faces Pain Scale score-revised, cut of points for analgesic requirement is ≧ 4, rescue analgesia will be administered in the form of nalbuphine 0.1 mg/kg, with a maximum dose of 0.2 mg/kg.
|
12 hours after surgery
|
|
Incidence of complications
Tidsram: 12 hours after surgery
|
Incidence of complications including hematomas block failure, intravascular injection, pneumothorax or injection into the peritoneal cavity, with associated risks of damage to bowel and other abdominal viscera at the block site will be recorded.
|
12 hours after surgery
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
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
- 00012098 (0109306)
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
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