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Bilateral Ultrasound-Guided Intra Muscular Quadratus Lumborum Block Versus Trans Muscular Quadratus Lumborum Block for Peri-Operative Analgesia in Abdominal Surgeries in Pediatric Patients. A Comparative Controlled Randomized Study.

K

Kasr El Aini Hospital

Status

Completed

Conditions

Pain, Acute

Treatments

Procedure: Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.
Procedure: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.
Procedure: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT04029987
N-31-2018

Details and patient eligibility

About

To compare between the intra muscular quadratous lamborum and the Trans muscular quadratous lamborum in pediatric population under going abdominal surgeries regards to first request of rescue analgesia, degree of pain relief, effect on hemo dynamic stability and incidence of complications.

Full description

The investigators hypothesized that an ultrasound guided quadratous lamborum block would prove successful peri-operative analgesia for abdominal surgeries in pediatric patients, and that Intra muscular quadratous lamborum is non inferior to Trans muscular blockade with the advantage of being safer (away from the peritoneum and retroperitoneal organs) and with the assumption that sarcolemmal layer in pediatrics should not resist the diffusion of the injectant from within the muscle out, to reach the inter fascial plane where the targeted nerves are found and cause an efficient blockade.

Enrollment

66 patients

Sex

All

Ages

5 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children age starting from 5 to 12 years.
  • Genders eligible for study: both sexes.
  • American Society Of Anesthesia (ASA) I-III.
  • Scheduled to undergo laparoscopy.

Exclusion criteria

  • Refusal of regional block or patients requiring emergency procedures.

    • Known Local Anesthetics drug sensitivity
    • Bleeding disorders with International Normalised Ratio (INR) > 1.5 and/or platelets < 100 000.
    • Skin lesions or wounds at site of proposed needle insertion.
    • Evidence of peritonitis or septicemia.
    • Hepatic disease or enlargement.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 3 patient groups, including a placebo group

Trans Muscular Quadratus Lumborum fascial plane Block
Active Comparator group
Description:
In group (Trans Muscular Quadratus Lumborum Block),will undergo ultrasound guided trans-muscular quadratus lamborum block as follows: A 22 G echogenic needle will be inserted in plane from the posterior (medial) end of the probe and directed for the fascial plane between the Quadratus Lumborum and the Psoas Major muscles through the Quadratus Lumborum muscle. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg per side of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side.
Treatment:
Procedure: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.
Intra Muscular Quadratus Lumborum fascial plane Block
Active Comparator group
Description:
In group Intra Muscular Quadratus Lumborum Block ,will undergo ultrasound guided intra-muscular quadratus lamborum (QL) block as follows: A 22 G echogenic needle will be inserted in plane from ventral (lateral) edge of the probe and advanced until penetration of QL muscle fascia is observed. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg per side of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side.
Treatment:
Procedure: Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.
group c → control
Placebo Comparator group
Description:
group c → control ,will receive conventional analgesia in the form of paracetamol with 15 mg\\ k.g every 6 hours, and naluphin 0.1 mg \\kg on demands
Treatment:
Procedure: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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