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Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children

19 mai 2022 mis à jour par: Kareem Mohammed Assem Nawwar, Cairo University

Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.

Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery & early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use.

Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time & hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block.

Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks.

In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

60

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Kareem MA Nawwar, M.D.
  • Numéro de téléphone: +201003878369
  • E-mail: drknawwar@cu.edu.eg

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 an à 6 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. American society of anesthesiologists (ASA) class I and II
  2. Children undergoing unilateral open renal surgeries

Exclusion Criteria:

  1. Parents refusal for the block
  2. Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
  3. Skin lesion, wounds or infection at the puncture site.
  4. Known allergy to local anesthetic drugs

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Erector spinae plane block (ESPB) group
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
Procédure: Ultrasound-guided Erector Spinae Plane Block
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane deep to erector spinae muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline and observing the fluid lifting the erector spinae muscle off the transverse process (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the spinous process on a parasagittal plane, to visualize the erector spinae muscle and transverse process, directing the needle craniocaudally using the in-plane technique. The spread of the injectate will be observed to distribute within this plane.
Dispositif: Ultrasound Machine
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
Dispositif: Echogenic needle
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Médicament: Fentanyl
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Médicament: Pethidine
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6. Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
Comparateur actif: Quadratus lumborum block (QLB) group
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
Dispositif: Ultrasound Machine
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
Dispositif: Echogenic needle
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Médicament: Fentanyl
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Médicament: Pethidine
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6. Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
Procédure: Ultrasound-guided Quadratus Lumborum Block
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane between the quadratus lumborum and psoas major muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the L2 spinous process on an axial plane, to visualize the transverse process with psoas major muscle anterior, quadratus lumborum muscle lateral and erector spinae muscle posterior to it. The needle is inserted from the medial side of the probe and advanced laterally using the in-plane technique. The spread of the injectate will be observed to distribute within the target plane.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time to first postoperative rescue analgesia
Délai: 12 hours
Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
12 hours

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Total opioid analgesic consumption in the first 12 hours postoperative period
Délai: from time of patient transfer to the PACU, till 12 hours postoperatively
when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
from time of patient transfer to the PACU, till 12 hours postoperatively
Intraoperative mean arterial blood pressure
Délai: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Intraoperative heart rate
Délai: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Postoperative pain score
Délai: from time of patient transfer to the PACU, till 12 hours postoperatively
measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
from time of patient transfer to the PACU, till 12 hours postoperatively
Block performance time
Délai: Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
Time to perform ultrasound guided nerve block
Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Indirect signs of local anesthetic toxicity
Délai: from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
intraoperative arrhythmias and delayed awakening
from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Les enquêteurs

  • Chaise d'étude: Nevine M Gouda, Cairo University
  • Chaise d'étude: Sherif M Soaida, Cairo University
  • Chaise d'étude: Ismail S Hammad, Cairo University
  • Chercheur principal: Ahmed T Bahnaswy, Cairo University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

20 mai 2022

Achèvement primaire (Anticipé)

1 septembre 2022

Achèvement de l'étude (Anticipé)

15 septembre 2022

Dates d'inscription aux études

Première soumission

8 mai 2022

Première soumission répondant aux critères de contrôle qualité

19 mai 2022

Première publication (Réel)

23 mai 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 mai 2022

Dernière vérification

1 mai 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • md-13-2022

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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