- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04998071
Posterior Quadratus Lumborum Block Using 0.125% Versus 0.25% Bupivacaine for Analgesia in Children Undergoing LPEC
Comparison of Analgesic Efficiency in Laparoscopic Percutaneous Extraperitoneal Closure for Pediatric Inguinal Hernia and Hydrocele Provided by Ultrasound Guided Posterior Quadratus Lumborum Block Using Between 0.125% and 0.25% Bupivacaine
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Fifty participants both male and female aged from 1 to 6 years old, AGED FROM 1 TO 6 YEARS OLD, ASA class I to II undergoing elective Laparoscopic percutaneous extraperitoneal closure for pediatric inguinal hernia and hydrocele will be randomly divided into two equal groups of twenty five by using computer generated random table.
All received premedication in the form of midazolam 0.1 mcg/kg IV. Perioperative monitoring included continuous ECG, NIBP and pulse oximetry. Baseline reading of these were recorded. General anesthesia will be inducted using thiopental 5 mg/kg then atracurium 0.5 mg/kg to facilitate endotracheal tube intubation and fentanyl 1 mcg/kg. Anesthesia will be maintained using 2% isoflurane with oxygen to air 40:60.
Posterior quadratus lumborum block (The technique which local anesthetic agent is injected at middle thoracolumbar fascia between erector spina muscle and quadratus lumborum muscle) provided by GE, LOGIQe VERSION (12L-RS, LINEAR ARRAY) ultrasound guided and using stimuplex needle 22G-2 inches on both sides under sterile technique in lateral position will be performed in all patients immediately after induction and before starting surgery. patients will be allocated randomly into two equal groups, twenty five in each as the following GROUP 1 will receive 0.25% bupivacaine 0.4 ml/kg. per each side. GROUP 2 will receive 0.125% bupivacaine 0.4 ml/kg. per each side. The patients and parents along with independent anesthesiologist and attending nurses were not aware of group allocation.
The surgical intervention was started not less than 10 minutes after block. Pneumoperitonium pressure was limited not exceed 10 mmHg. After completion of surgery, anesthesia was discontinued and muscle relaxant was reversed as usual. After extubation, the patients will be transfer to PACU.
Postoperative pain will be assessed by attending nurses, using CHEOPs SCORE. Acetaminophen 10 mg/kg. orally will be given as rescue analgesia for patient with CHEOPs SCORE more than 6. Parameters will be assessed
Intraoperative measurements:
- Hemodynamic parameters: HR and MAP were recorded before, immediately and every 5 minutes after induction of anesthesia until the end of the operation.
- Analgesic requirement: All through the procedure (By measure analgesic need intraoperative in the form of fentanyl 0.5 mcg/kg) In case of increase in intraoperative MAP or HR of more than 20% from baseline.
- Incidence of complications: In the form of hypotension, hematoma, intraabdominal organ injury LAST.
Postoperative measurements:
- Quality of analgesia: Assessed immediately postoperatively every 30 minutes in the PACU and then at 4, 8, 12 hours at ward using CHEOPs SCORE and 24 hours postoperatively using PARENT'S POSTOPERATIVE PAIN MEASUREMENT(PPPM).
- Incidence of complications: In the form assessment of intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability.
- Others: In the form of parent's satisfaction of analgesia and length of hospital stay.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: SUWITCHA TAMRONGCHOTE, MD
- Numero di telefono: +66989425629
- Email: S.NI.KTAMP@GMAIL.COM
Backup dei contatti dello studio
- Nome: NUTTAPHONG LEPANANON, MD
- Numero di telefono: +66850602800
- Email: N_PEDIAN@HOTMAIL.COM
Luoghi di studio
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Bangkok
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Ratchathewi, Bangkok, Tailandia, 10400
- Reclutamento
- Queen Sirikit National Institute of Child Health
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Contatto:
- Kullasate Sakpichaisakul, MD
- Email: kullasate.s@rsu.ac.th
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Contatto:
- Kantapon Trongkamolchai, MD
- Email: kantapon260619870@gmail.com
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Investigatore principale:
- Kullasate Sakpichaisakul, MD
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Sub-investigatore:
- Kantapon Trongkamolchai, MD
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Sub-investigatore:
- Somjit Sri-udomkajorn, MD
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Sub-investigatore:
- Sirorat Suwannachote, MD
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Sub-investigatore:
- Ravivan Wittawassamrankul, R Ph
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Sub-investigatore:
- Ravindra Arya, MD, DM
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Sub-investigatore:
- Suwitcha Tamrongchote, MD
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Children scheduled for laparoscopic percutaneous extraperitoneal closure(LPEC) for pediatric inguinal hernia and hydrocele
- ASA I-II physical status patients
- Complete inform consent for intervention
Exclusion Criteria:
- Contraindication for regional anesthesia
- Sensitive to local anesthetic agent, opioid or acetaminophen
- Previous history of abdominal surgery
- History of neuromuscular disease
- G6PD deficiency
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: ROUTINE DRUG - CONCENTRATION QLB
The patients will receive bilateral posterior quadratus lumborum block using 0.25% bupivacaine 0.4 ml/kg. in each side.
|
Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC
|
Comparatore attivo: ALTERNATIVE DRUG - CONCENTRATION QLB
The patients will receive bilateral posterior quadratus lumborum block using 0.125% bupivacaine 0.4 ml/kg. in each side.
|
Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Quality of postoperative analgesia
Lasso di tempo: 24 hours after surgery
|
Postoperative pain score as CHEOPs SCORE
|
24 hours after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Incidence of complications
Lasso di tempo: 12 hours after surgery
|
Intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability
|
12 hours after surgery
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: SUWITCHA TAMRONGCHOTE, MD, Queen Sirikit National Institute of Child Health (QSNICH)
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REC.015/2564
Informazioni su farmaci e dispositivi, documenti di studio
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