Pediatric Postoperative Analgesia With Quadratus Lumborum Block(QLB) And Dexamethasone As An Adjuvant To Bupivacaine.

Tanta University

Status: Completed

Conditions: Quadratus Lumborum Block; Abdominal Surgery; Pediatric; Post Operative Pain

Treatments: Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously; Drug: Bupivacaine Injection; Procedure: ultrasound guided quadratus lumborum block; Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally

Study type: Interventional

Funder types: Other

Identifiers

NCT04963816

34737/6/21

Details and patient eligibility

About

Studying the post-operative analgesic effect of dexamethasone as an adjuvant to bupivacaine giving intravenously and locally with ultrasound guided quadratus lumborum block(QLB) in pediatrics undergoing abdominal surgeries

Full 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).

Enrollment: 3 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 3 patient groups, including a placebo group

Group A Quadratus Lumborum Block with dexamethasone IV

Active Comparator group

Description:

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

Treatment:

Procedure: ultrasound guided quadratus lumborum block

Drug: Bupivacaine Injection

Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously

Group B Quadratus Lumborum Block with dexamethasone locally

Active Comparator group

Description:

QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline

Treatment:

Procedure: ultrasound guided quadratus lumborum block

Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally

Drug: Bupivacaine Injection

Group C Quadratus Lumborum Block with bupivacaine alone

Placebo Comparator group

Description:

Patients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline.

Treatment:

Procedure: ultrasound guided quadratus lumborum block

Drug: Bupivacaine Injection