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.

NCT04029987 | Completed DMC

• 1 other identifier: N-31-2018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Time of the first postoperative analgesic request

  (duration of the block, time spent post-operative before rescue opioid is needed at pain score of 6 or higher, up to 12 hours post operative.

  starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours

Secondary Outcomes (6)

• total opioid consumption over the first 12 hours.

  through out the first 12 hours post operative.

• Pain score up to 12 hours after surgery.

  through out the first 12 hours post operative.

• Block failure

  through out the first hour post operative.

• Ease of performance of each technique

  through out the block performance time

• Block performance time

  starting from probe contact with skin till 30 minutes.

Other Outcomes (6)

• patient's heart rate

  starting from 5 minutes after intubation till 30 minutes after extubation

• patient's systolic blood pressure

  starting from 5 minutes after intubation till 30 minutes after extubation

• patient's diastolic blood pressure

  starting from 5 minutes after intubation till 30 minutes after extubation

Study Arms (3)

Trans Muscular Quadratus Lumborum fascial plane Block

ACTIVE COMPARATOR

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.

Procedure: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.

Intra Muscular Quadratus Lumborum fascial plane Block

ACTIVE COMPARATOR

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.

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

group c → control

PLACEBO COMPARATOR

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

Procedure: Control

Interventions

Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block. 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.

Trans Muscular Quadratus Lumborum fascial plane Block

Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block. 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.

Intra Muscular Quadratus Lumborum fascial plane Block

Control PROCEDURE

Conventional analgesia

group c → control

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Abu ElReesh hospital, Cairo university Hospital,Kasr Alini

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients, parents and data analysts will be blinded to group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: July 23, 2019
• Study Start: October 25, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)