- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963816
Pediatric Postoperative Analgesia With Quadratus Lumborum Block(QLB) And Dexamethasone As An Adjuvant To Bupivacaine. (QLB)
Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial
Study Overview
Status
Detailed Description
After obtaining written informed consent from parents or guardians of all patients, 90 patients (6-12 years old) scheduled for abdominal surgeries operations will be included. Patients will be randomly allocated into three groups, 30 patients in each group. Randomization will be based on computer-generated codes maintained in sequentially numbered opaque envelopes.
Anesthetic Technique:
Anesthesia will be induced with Sevoflurane plus fentanyl (0.5µg/kg) and tracheal intubation will be facilitated with Rocuronium (0.4 mg/kg). Anesthesia will be maintained with Sevoflurane (will be adjusted according to A line autoregressive index (AAI)) and Rocuronium (0.1 mg/kg/dose will be given on the basis of train-of-four neuromuscular monitoring). ECG, noninvasive blood pressure, heart rate, temperature, oxygen saturation, and exhaled CO2 (end tidal CO2) will be continuously monitored during the procedure.
• After induction of anesthesia and before skin incision, a QLB will be performed in all patients in the three groups.
The procedure will be done under ultrasound guidance using curved array transducer 5-2MHz (Sonosite ultrasound system). Echogenic needle, Sono Plex Stim cannula (PAJUNK) 22 gauge and 60 mm length will be used. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The QLB block will be performed by anterior approach. The linear probe will be attached in the area of the triangle of Petit in transverse orientation in lateral abdomen in between the iliac crest and the costal margin, near the posterior axillary line. The muscle planes will be identified until visualizing the quadratus lumborum muscle, at the same plane as the psoas major muscle and the erector spinae. The needle tip is placed at the anterolateral border of the QL at its junction of QL with transversalis fascia outside the anterior layer of the thoracolumbar fascia (TLF) and fascia transversalis, and the local anesthetic will be injected.
Anesthesia will be discontinued when the wound dressing applied, and muscle relaxant will be reversed using (50ug/kg) of neostigmine and atropine (0.02mg/kg) and extubating of the patient will be done. The patient will be transferred to the postoperative care unit (POCU).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Algharbia
-
Tanta, Algharbia, Egypt, 0000
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pediatric patients(6-12 years)
- ASA physical status I,II
- Abdominal surgery
Exclusion Criteria:
- Parents refusal or legal guardian's refusal
- Allergy to bupivacaine or dexamethasone
- Contraindications to regional techniques
- Failed QLB
- Infection on site of procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group A Quadratus Lumborum Block with dexamethasone IV
QLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline
|
Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach
Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A
Other Names:
Bupivacaine will be given to all groups locally with QLB
Other Names:
|
ACTIVE_COMPARATOR: Group B Quadratus Lumborum Block with dexamethasone locally
QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline
|
Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach
Bupivacaine will be given to all groups locally with QLB
Other Names:
Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B
Other Names:
|
PLACEBO_COMPARATOR: Group C Quadratus Lumborum Block with bupivacaine alone
Patients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline.
|
Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach
Bupivacaine will be given to all groups locally with QLB
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative analgesia
Time Frame: 24 hours
|
using the Pediatric Objective Pain Scale (15), where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia.
|
24 hours
|
The duration of analgesia
Time Frame: 24 hours
|
the time starting from extubation until analgesia will be required as evidenced by a pain score > 4.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total amount of paracetamol doses
Time Frame: 24 hours
|
paracetamol doses (15 mg/kg per dose) as a rescue analgesic will be needed after the onset of pain
|
24 hours
|
Postoperative vomiting
Time Frame: 12 hours
|
vomiting and/or retching without expulsion of gastric content will be recorded by a nurse who will be blinded to study conditions.
It will treated if vomiting occurred more than twice in 2 minutes with by granisetron
|
12 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: SHERIF K ARAFA, MD, ASSISTANT PROFESSOR of anesthesia and surgical ICU
- Study Chair: AMIR A EL SAYED, MD, ASSISTANT PROFESSOR of anesthesia and surgical ICU
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Anesthetics, Local
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Pharmaceutical Solutions
- Bupivacaine
- Dexamethasone 21-phosphate
Other Study ID Numbers
- 34737/6/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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