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Posterior Quadratus Lumborum Block Using 0.125% Versus 0.25% Bupivacaine for Analgesia in Children Undergoing LPEC

1. august 2021 opdateret af: Kullasate Sakpichaisakul, Queen Sirikit National Institute of Child Health

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

The aim of the present study is to evaluate and compare the analgesic efficiency of the difference concentration between 0.125% and 0.25% bupivacaine provided by ultrasound guided posterior quadratus lumborum block undergoing LPEC in children

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  1. Hemodynamic parameters: HR and MAP were recorded before, immediately and every 5 minutes after induction of anesthesia until the end of the operation.
  2. 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.
  3. Incidence of complications: In the form of hypotension, hematoma, intraabdominal organ injury LAST.

Postoperative measurements:

  1. 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).
  2. Incidence of complications: In the form assessment of intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability.
  3. Others: In the form of parent's satisfaction of analgesia and length of hospital stay.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Rekruttering
        • Queen Sirikit National Institute of Child Health
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Kullasate Sakpichaisakul, MD
        • Underforsker:
          • Kantapon Trongkamolchai, MD
        • Underforsker:
          • Somjit Sri-udomkajorn, MD
        • Underforsker:
          • Sirorat Suwannachote, MD
        • Underforsker:
          • Ravivan Wittawassamrankul, R Ph
        • Underforsker:
          • Ravindra Arya, MD, DM
        • Underforsker:
          • Suwitcha Tamrongchote, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 6 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Aktiv komparator: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of postoperative analgesia
Tidsramme: 24 hours after surgery
Postoperative pain score as CHEOPs SCORE
24 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of complications
Tidsramme: 12 hours after surgery
Intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability
12 hours after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: SUWITCHA TAMRONGCHOTE, MD, Queen Sirikit National Institute of Child Health (QSNICH)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

15. august 2021

Primær færdiggørelse (Forventet)

31. maj 2022

Studieafslutning (Forventet)

30. juni 2022

Datoer for studieregistrering

Først indsendt

9. juli 2021

Først indsendt, der opfyldte QC-kriterier

1. august 2021

Først opslået (Faktiske)

10. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2021

Sidst verificeret

1. august 2021

Mere information

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Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Bupivacaine hydrochloride

3
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