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.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute
• Intervention / Treatment: Procedure: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.; Procedure: Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.; Procedure: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Abu ElReesh hospital, Cairo university Hospital,Kasr Alini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: 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.
ACTIVE_COMPARATOR: 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.	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.
PLACEBO_COMPARATOR: 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	Procedure: Control; Conventional analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
total opioid consumption over the first 12 hours.	rescue analgesia in the form of intravenous nalbuphine 0.1 milligram/Kilogram will be given for a Wong-Baker Faces Scale more than 4 up to 12 hours post operative.	through out the first 12 hours post operative.
Pain score up to 12 hours after surgery.	Postoperative pain score for each patient will be assessed by Wong-Baker Faces Scale at the following intervals: 15, 30, and 60 min, 6, and 12 hours after surgery.	through out the first 12 hours post operative.
Block failure	a failed block is where the patient requires more than two doses of rescue analgesia in the first hour postoperatively	through out the first hour post operative.
Ease of performance of each technique	Easiness of performance of the technique, rated on a simple verbal scale easy/moderately difficult/difficult) and defined as follows: Easy block: successful block after the 1st skin puncture.; Moderately difficult block: successful block after more than one puncture or with the need for needle redirection or image optimization (as adjustment of depth, gain, or focus to visualize the needle path); Difficult block: successful block after more than one puncture and with the with the need for needle redirection and image optimization	through out the block performance time
Block performance time	Block performance time in minutes which is the time from probe contact with skin till needle withdrawal	starting from probe contact with skin till 30 minutes.
The incidence of post block adverse effects	incidence of complications, such as: postoperative nausea and vomiting, urinary retention, lower limb weakness; injury to the underlying structures (injury to the liver or a viscus), or hematoma formation as recorded under ultrasound guidance; need of postoperative mechanical ventilation or ICU admission; LA toxicity.	starting after the block is given up to the first 12 hours post operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient's heart rate	heart rate will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area.	starting from 5 minutes after intubation till 30 minutes after extubation
patient's systolic blood pressure	systolic blood pressure will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area.	starting from 5 minutes after intubation till 30 minutes after extubation
patient's diastolic blood pressure	diastolic blood pressure will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area.	starting from 5 minutes after intubation till 30 minutes after extubation
intraoperative administration of extra analgesic dose of fentanyl	Number of patients in each group who needed intraoperative administration of extra analgesic dose of fentanyl 0.5 microgram/kilogram),in patients showing increase in heart rate and/or arterial blood pressure 10 minutes after returning to supine position after the block is given, by more than 20% of baseline values (5 minutes after intubation) in response to surgical stimulus or thereafter throughout the whole operation.	starting from 10 minutes after the chosen block is given till extubation.
Duration of surgery	time in minutes from skin incision till skin closure	starting from skin incision up to skin closure.
Duration of general anesthesia	time in minutes from induction of GA till extubation	starting from induction of anesthesia till extubation

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2018
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: December 2, 2018
• First Submitted That Met QC Criteria: July 20, 2019
• First Posted (ACTUAL): July 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: N-31-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No