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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT04963816

Collaborator

(none)

Enrollment

Location

Arms

6.8

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Quadratus Lumborum Block Pediatric Abdominal Surgery	Procedure: ultrasound guided quadratus lumborum block Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously Drug: Bupivacaine Injection Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial

Actual Study Start Date :

Jun 16, 2021

Actual Primary Completion Date :

Oct 30, 2021

Actual Study Completion Date :

Jan 10, 2022

Arms and Interventions

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	Procedure: ultrasound guided quadratus lumborum block 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 Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A Other Names: Dexamethasone as an adjuvant intravenously Drug: Bupivacaine Injection Bupivacaine will be given to all groups locally with QLB Other Names: Light marcaine
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	Procedure: ultrasound guided quadratus lumborum block 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 Drug: Bupivacaine Injection Bupivacaine will be given to all groups locally with QLB Other Names: Light marcaine Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B Other Names: Dexamethasone as an adjuvant locally
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.	Procedure: ultrasound guided quadratus lumborum block 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 Drug: Bupivacaine Injection Bupivacaine will be given to all groups locally with QLB Other Names: Light marcaine

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

Procedure: ultrasound guided quadratus lumborum block

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

Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously

Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A

Other Names:

Dexamethasone as an adjuvant intravenously

Drug: Bupivacaine Injection

Bupivacaine will be given to all groups locally with QLB

Other Names:

Light marcaine

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

Procedure: ultrasound guided quadratus lumborum block

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

Drug: Bupivacaine Injection

Bupivacaine will be given to all groups locally with QLB

Other Names:

Light marcaine

Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally

Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B

Other Names:

Dexamethasone as an adjuvant locally

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.

Procedure: ultrasound guided quadratus lumborum block

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

Drug: Bupivacaine Injection

Bupivacaine will be given to all groups locally with QLB

Other Names:

Light marcaine

Outcome Measures

Primary Outcome Measures

Postoperative analgesia [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.
The duration of analgesia [24 hours]
the time starting from extubation until analgesia will be required as evidenced by a pain score > 4.

Secondary Outcome Measures

The total amount of paracetamol doses [24 hours]
paracetamol doses (15 mg/kg per dose) as a rescue analgesic will be needed after the onset of pain
Postoperative vomiting [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University	Tanta	Algharbia	Egypt	0000

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: AHMED A SHAMA, MD, Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine
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