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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

age:5-12, American Society of Anesthesia I-III, abdominal laparoscopies, randomly allocated into one of the study groups, randomization sequence will be concealed in sealed envelopes with alphabetic codes. The identifiers will be attached to the opened envelopes and secured by dedicated person independent of randomization proceedings. Patients, parents and data analysts will be blinded to group assignments.

The groups:

* group A → Trans muscular quadrous lamborum block (n=22)
* group B → Intra muscular quadrous lamborum block (n=22)
* group c → control (n=22) will receive conventional analgesia. Sample size Starting number of 22 patients for each group, Recalculation of the sample size will be carried out after studying 10 patients per group.

The alpha error is set at 0.05 and the study power is 0.95.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Patients, parents and data analysts will be blinded to group assignments.

Study Groups

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Trans Muscular Quadratus Lumborum fascial plane Block

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.

Group Type ACTIVE_COMPARATOR

Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.

Intervention Type PROCEDURE

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 Psoa 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 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.

Intra Muscular Quadratus Lumborum fascial plane Block

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.

Group Type ACTIVE_COMPARATOR

Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.

Intervention Type PROCEDURE

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 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.

group c → control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

Conventional analgesia

Interventions

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Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.

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 Psoa 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 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.

Intervention Type PROCEDURE

Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.

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 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.

Intervention Type PROCEDURE

Control

Conventional analgesia

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes