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Completed

NCT Number: NCT04963816

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

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

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Algharbia, 0000, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound guided quadratus lumborum block

Procedure

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

Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously

Drug

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

Bupivacaine Injection

Drug

Bupivacaine will be given to all groups locally with QLB

Other names: Light marcaine

Dexamethasone Phosphate 4 MG/ML Injectable Solution locally

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: QLB

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 15, 2021
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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