To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing postoperative pain, opioid consumption, and recovery time following elective inguinal herniorraphy.
The primary outcome:
• to compare between caudal block and ultrasound guided quadratus lamborum block.
The secondary outcome:
Condition or disease | Intervention/treatment | Phase |
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Pain, Postoperative | Procedure: Hernioraphy/Caudal block Procedure: Hernioraphy/Quadratus Lumborum block | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block for Inguinal Hernioraphy in Preschool Children. |
Actual Study Start Date : | October 1, 2019 |
Actual Primary Completion Date : | December 10, 2019 |
Actual Study Completion Date : | December 11, 2019 |
Arm | Intervention/treatment |
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Active Comparator: Hernioraphy/Caudal block
patients will receive a caudal block after induction of general anaesthesia.
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Procedure: Hernioraphy/Caudal block
30 patients will receive a caudal block after induction of general anaesthesia
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Active Comparator: Hernioraphy/Quadratus Lumborum block
patients will receive ultrasound guided quadrates lumborum block (QL )
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Procedure: Hernioraphy/Quadratus Lumborum block
30 patients will receive ultrasound guided quadrates lumborum block
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Ages Eligible for Study: | 2 Years to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Patients , aged 2 to 5 years and American Society of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a randomized double blinded study.
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Exclusion Criteria:
Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal
Egypt | |
Alexandria Faculty of Medicine | |
Alexandria, Egypt, 21111 |
Principal Investigator: | Mohammad Hazem I Ahmad Sabry, MB,ChB MD | Alexandria University |
Tracking Information | |||||
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First Submitted Date ICMJE | January 17, 2019 | ||||
First Posted Date ICMJE | January 22, 2019 | ||||
Last Update Posted Date | January 2, 2020 | ||||
Actual Study Start Date ICMJE | October 1, 2019 | ||||
Actual Primary Completion Date | December 10, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Postoperative pain. [ Time Frame: 24 hours ] FLACC Scale from 0 to 10
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block in Children | ||||
Official Title ICMJE | Ultrasound Guided Caudal Block Versus Quadratus Lumborum Block for Inguinal Hernioraphy in Preschool Children. | ||||
Brief Summary |
To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing postoperative pain, opioid consumption, and recovery time following elective inguinal herniorraphy. The primary outcome: • to compare between caudal block and ultrasound guided quadratus lamborum block. The secondary outcome:
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Detailed Description |
After approval of Ethics Committee of the Faculty of Medicine, and taking a written informed consent from the guardians of each patient, the present study will be carried out in Alexandria Main University Hospitals on 60 patients , aged 2 to 5 years and American Society of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a randomized double blinded study. The sample size was calculated by High Institute of Public Health. Exclusion Criteria: Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal The patients will be randomly divided by closed envelope technique into two groups: Group I: 30 patients will receive a caudal block after induction of general anaesthesia. Group II::Will receive ultrasound guided quadrates lumborum block (QL ) ( posterior transmuscular approach ) using 0.5 mL/kg 0.25% bupivacaine to be applied between the QL muscles and the thoracolumbar fascia. . METHOD Preoperative Assessment:
Pre anaesthetic preparation and premedication
A multi-channel monitor will be attached to the patient to display:
Induction of anesthesia General anesthesia will be induced with sevoflurane and 50% air in oxygen then IV access will be inserted . Fentanyl will be administered at 1 μg/kg, and a laryngeal mask airway will be used to secure the upper airway. Anaesthesia will be maintained with sevoflurane 2% and 50% air in oxygen.
According to the studied group, patients will receive after induction either Group I: caudal block. Group II: Quadratus lamborum block. Technique: -For the caudal block, the patients were first inducted by GA and then they were placed in the altered left lateral position. The block site, which was mainly at the sacral hiatus, was sterilized with betadine, and the sacral hiatus between the sacral conui was palpated. Then a 23-gage short needle injection was used with the bevel towards the abdomen to puncture the sacral surface at a 45-degree angle. When the sacrococcygeal ligament seemed to have punctured, the needle was tilted more towards the skin surface and the needle was inserted 2-3 mm deeper. The needle was aspired to check for blood and cerebral spinal fluid extravasations. The loss of resistance was confirmed with air-infusion. Then 0.25% bupivacaine 1 ml/kg was infused. (8,9). In the QL block group, the probe will be placed anterior and superior to the iliac crest, and the 3 abdominal wall muscles will be visualized. The external abdominal oblique muscle will be followed posterolaterally until the posterior border of the muscle will be identified. When the probe is tilted to the attachment site of both the internal abdominal oblique muscle and the external abdominal oblique muscle over the QL, the midline of the thoracolumbar fascia will be seen as a bright hyperechogenic line. A 22-gauge 80-mm Quincke-type SonoPlex needle (Pajunk, Geisingen,Germany) will be inserted using an in-plane technique. The needle will be directed from anterolateral to posteromedial after making a negative aspiration test with 0.5 mL normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 0.5 mL/kg 0.25% bupivacaine will be applied between the QL muscles and the thoracolumbar fascia(10). The operation will be planned to begin 7 to 10 minutes after the block is applied , and all patients will be operated on with a standardized technique. Pain levels will be assessed using a FLACC(11) (Face, Legs, Activity, Cry, Consolability ) behavioral pain assessment scale postoperatively . When the FLACC score is 4 or greater ibuprofen 7mg/kg will be administered orally . Any complications occurring during the procedure will be recorded and treated :
< 60 bpm in kids 3-7 years old . Treated by 0.01-0.02 mg/kg atropine . • Nausea and vomiting treated with ondansetron 0.1mg/kg intravenously(15) . MEASURMENTS: The following parameters will be measured for all patients:
A-Haemodynamics
B-Need for intraoperative rescue analgesia: Adequate intraoperative analgesia was defined by hemodynamic stability, as indicated by the absence of an increase in heart rate or systolic arterial pressure 15% compared with baseline values obtained just before surgical incision. An intraoperative increase in blood pressure (BP) or heart rate (HR) by 15% was defined as insufficient analgesia and was treated with a rescue opioid (fentanyl; 1mcg/kg). C-Assessment of Postoperative analgesia For postoperative pain evaluation, the pain scores were measured and the facial pain scores were taken 10 min, 30 min and 60 min upon arriving into the PACU. The patients were moved to their wards after 90 min passed in the PACU. At 120 min. post-surgery, the last pain scores were taken. The pain scores were taken when the patient was not crying. If the pain score was over 0.6, then paracetamol 15 mg/kg was infused. D-Analgesic requirements
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Pain, Postoperative | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | December 11, 2019 | ||||
Actual Primary Completion Date | December 10, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Patients , aged 2 to 5 years and American Society of Anaesthesiologists (ASA) physical status I or II who will be scheduled for elective inguinal herniorraphy in a randomized double blinded study. - Exclusion Criteria: Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal |
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Sex/Gender ICMJE |
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Ages ICMJE | 2 Years to 5 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Egypt | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03811392 | ||||
Other Study ID Numbers ICMJE | 050108018(18/12/2018) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mohammad Hazem I. Ahmad Sabry, University of Alexandria | ||||
Study Sponsor ICMJE | University of Alexandria | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of Alexandria | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |