Clinical Trials Logo

Clinical Trial Summary

The aim of this work to compare the analgesic efficacy of preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block in pediatric patients undergoing pyeloplasty surgeries.


Clinical Trial Description

This randomized, controlled study is designed to: - Assess the quality of perioperative analgesia (intraoperative hemodynamics, postoperative pain score and analgesic consumption) provided by ultrasound guided subcostal TAP and quadratus lumborum blocks in pediatrics undergoing pyeloplasty surgeries. - Compare the efficacy and safety of both blocks in pediatrics undergoing pyeloplasty surgery. Hypothesis Following approval from research and ethics committee of anesthesia department, Faculty of Medicine, Cairo University, children will be pre-medicated by intramuscular injection of atropine 0.02 mg/Kg, midazolam 0.2 mg/Kg and ketamine 2 mg/ Kg before admission to operation theater (OR). Upon arrival to OR; continuous electrocardiography (ECG), pulse oximetry, non-invasive arterial blood pressure will be applied and baseline readings will be recorded, then general anesthesia will be induced by 8% sevoflurane and 50% air in oxygen. Peripheral venous cannula will be inserted after loss of consciousness. If a patient had an intravenous (IV) cannula, induction will be performed using 1.5-2.5 mg/kg propofol, in both situations atracurium at a dose of 0.5 mg/kg will be given intravenously to facilitate endotracheal intubation and fentanyl at a dose 2 µg/kg will be given to abolish stress response of intubation. Anesthesia will be maintained by using 1-1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes. Patient positioning and preparation for the block: For the (sTAP) group (n=39): patients will be in the supine position; after preparing the skin with with povidone iodine, a high frequency (5-10 MHz) ultrasound probe will be placed obliquely on the upper abdominal wall, along the surgical site subcostal margin near the midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally along the subcostal margin until we identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in-plane technique will be inserted medially near the xiphoid process aiming towards the iliac crest, then 1 mL/Kg of bupivacaine 0.25% will be injected in the plane between rectus abdominis and transversus abdominis muscles. The patient will then be positioned for the procedure if other than supine position is chosen. For the (QLB) group (n=39): patients will be positioned in the lateral decubitus position so that the blocked side will be the uppermost one. After skin sterilization with povidone iodine the ultrasound probe will be positioned between the iliac crest and the costal margin at the level of the anterior axillary line to identify the three thin parallel muscles of the anterolateral abdominal wall. The probe will be moved posteriorly following the narrowing of the muscles until the muscle fibers of transversus abdominis muscles taper off into its aponeurosis at the level of the posterior axillary line where the quadratus lumborum muscle is identified. The posterior aspect of the QL muscle is confirmed and a 22 G echogenic needle will be inserted using an in-plane technique from anterolateral to posteromedial towards this posterior aspect of the QL muscle. 1 mL/Kg of bupivacaine 0.25% will be injected behind the QL muscle on the lateral border of the erector spinae muscle. The patient will then be positioned for the procedure if other than lateral decubitus position is chosen. Vital signs (heart rate (HR) and non-invasive blood pressure) will be recorded at the onset of the block then every 15 minutes intraoperatively, and every 4 hours postoperatively for a period of 24 hours. Fentanyl 0.5 µg /kg as rescue analgesia will be given intraoperatively if HR and or systolic BP increased >20% of baseline up to maximum 5 µg/ kg. After skin closure, inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered IV after return of patient's spontaneous breathing. Patients will then be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and monitoring. Postoperative assessment and analgesic regimen: The Face, Legs, Activity, Cry, Consolability scale (FLACC) (table 1) will be assessed immediately postoperative in the PACU and every 4 hours in the ward for 24 hours. The time to the first request of rescue postoperative analgesic will be: "the time interval between the local anesthesia injection and the first request to postoperative analgesia (patients first complain of pain and or FLACC score ≥4)". an intravenous paracetamol 15mg/kg will be given immediately postoperative and will be repeated every 6 hours. Persistent or breakthrough pain will be managed with incremental intravenous morphine at a dose of 0.05-0.1mg/kg to maintain resting FLACC scale ˂ 4 (maximum dose 0.3mg/kg). Cumulative 24 hours analgesic consumption will be recorded. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04269460
Study type Interventional
Source Kasr El Aini Hospital
Contact
Status Completed
Phase N/A
Start date February 1, 2020
Completion date March 1, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas