Back to resultsBilateral 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.
Primary Purpose
Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.
Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.
Control
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Acute
Eligibility Criteria
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.
Sites / Locations
- Abu ElReesh hospital, Cairo university Hospital,Kasr Alini
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Trans Muscular Quadratus Lumborum fascial plane Block
Intra Muscular Quadratus Lumborum fascial plane Block
group c → control
Arm 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.
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 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Block failure
a failed block is where the patient requires more than two doses of rescue analgesia in the first hour postoperatively
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
Block performance time
Block performance time in minutes which is the time from probe contact with skin till needle withdrawal
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.
Full Information
NCT ID
NCT04029987
First Posted
December 2, 2018
Last Updated
January 19, 2020
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04029987
Brief Title
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.
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients, parents and data analysts will be blinded to group assignments.
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trans Muscular Quadratus Lumborum fascial plane Block
Arm Type
Active Comparator
Arm 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.
Arm Title
Intra Muscular Quadratus Lumborum fascial plane Block
Arm Type
Active Comparator
Arm 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.
Arm Title
group c → control
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.
Intervention Description
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
Intervention Name(s)
Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
Conventional analgesia
Primary Outcome Measure Information:
Title
Time of the first postoperative analgesic request
Description
(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.
Time Frame
starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours
Secondary Outcome Measure Information:
Title
total opioid consumption over the first 12 hours.
Description
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.
Time Frame
through out the first 12 hours post operative.
Title
Pain score up to 12 hours after surgery.
Description
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.
Time Frame
through out the first 12 hours post operative.
Title
Block failure
Description
a failed block is where the patient requires more than two doses of rescue analgesia in the first hour postoperatively
Time Frame
through out the first hour post operative.
Title
Ease of performance of each technique
Description
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
Time Frame
through out the block performance time
Title
Block performance time
Description
Block performance time in minutes which is the time from probe contact with skin till needle withdrawal
Time Frame
starting from probe contact with skin till 30 minutes.
Title
The incidence of post block adverse effects
Description
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.
Time Frame
starting after the block is given up to the first 12 hours post operative
Other Pre-specified Outcome Measures:
Title
patient's heart rate
Description
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.
Time Frame
starting from 5 minutes after intubation till 30 minutes after extubation
Title
patient's systolic blood pressure
Description
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.
Time Frame
starting from 5 minutes after intubation till 30 minutes after extubation
Title
patient's diastolic blood pressure
Description
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.
Time Frame
starting from 5 minutes after intubation till 30 minutes after extubation
Title
intraoperative administration of extra analgesic dose of fentanyl
Description
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.
Time Frame
starting from 10 minutes after the chosen block is given till extubation.
Title
Duration of surgery
Description
time in minutes from skin incision till skin closure
Time Frame
starting from skin incision up to skin closure.
Title
Duration of general anesthesia
Description
time in minutes from induction of GA till extubation
Time Frame
starting from induction of anesthesia till extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Abu ElReesh hospital, Cairo university Hospital,Kasr Alini
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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