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

NCT ID: NCT04963816

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2022-01-10

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

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ultrasound guided quadratus lumborum block

Intervention Type: 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

Intervention Type: DRUG

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

Bupivacaine Injection

Intervention Type: DRUG

Bupivacaine will be given to all groups locally with QLB

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

Group Type: ACTIVE_COMPARATOR

ultrasound guided quadratus lumborum block

Intervention Type: 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

Bupivacaine Injection

Intervention Type: DRUG

Bupivacaine will be given to all groups locally with QLB

Dexamethasone Phosphate 4 MG/ML Injectable Solution locally

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

ultrasound guided quadratus lumborum block

Intervention Type: 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

Bupivacaine Injection

Intervention Type: DRUG

Bupivacaine will be given to all groups locally with QLB

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Bupivacaine Injection

Bupivacaine will be given to all groups locally with QLB

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Dexamethasone as an adjuvant intravenously; Light marcaine; Dexamethasone as an adjuvant locally

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

AHMED ABDELAZIZ SHAMA

Lecturer and consultant of anesthesia and surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED A SHAMA, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine

SHERIF K ARAFA, MD

Role: STUDY_CHAIR

ASSISTANT PROFESSOR of anesthesia and surgical ICU

AMIR A EL SAYED, MD

Role: STUDY_CHAIR

ASSISTANT PROFESSOR of anesthesia and surgical ICU

Locations

Tanta University

Tanta, Algharbia, Egypt

Countries

Egypt

References

Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.

Reference Type: DERIVED

PMID: 36288584 (View on PubMed)

Other Identifiers

34737/6/21

Identifier Type: -

Identifier Source: org_study_id