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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: SUWITCHA TAMRONGCHOTE, MD
- Telefoonnummer: +66989425629
- E-mail: S.NI.KTAMP@GMAIL.COM
Studie Contact Back-up
- Naam: NUTTAPHONG LEPANANON, MD
- Telefoonnummer: +66850602800
- E-mail: N_PEDIAN@HOTMAIL.COM
Studie Locaties
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Bangkok
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Ratchathewi, Bangkok, Thailand, 10400
- Werving
- Queen Sirikit National Institute of Child Health
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Contact:
- Kullasate Sakpichaisakul, MD
- E-mail: kullasate.s@rsu.ac.th
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Contact:
- Kantapon Trongkamolchai, MD
- E-mail: kantapon260619870@gmail.com
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Hoofdonderzoeker:
- Kullasate Sakpichaisakul, MD
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Onderonderzoeker:
- Kantapon Trongkamolchai, MD
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Onderonderzoeker:
- Somjit Sri-udomkajorn, MD
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Onderonderzoeker:
- Sirorat Suwannachote, MD
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Onderonderzoeker:
- Ravivan Wittawassamrankul, R Ph
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Onderonderzoeker:
- Ravindra Arya, MD, DM
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Onderonderzoeker:
- Suwitcha Tamrongchote, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: 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
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Quality of postoperative analgesia
Tijdsspanne: 24 hours after surgery
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Postoperative pain score as CHEOPs SCORE
|
24 hours after surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Incidence of complications
Tijdsspanne: 12 hours after surgery
|
Intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability
|
12 hours after surgery
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: SUWITCHA TAMRONGCHOTE, MD, Queen Sirikit National Institute of Child Health (QSNICH)
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REC.015/2564
Informatie over medicijnen en apparaten, studiedocumenten
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