Pain, AcuteNCT04029987

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.

A study testing Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block. and Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block. in people with Pain, Acute, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 5 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Acute
What is being tested?: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block. and Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteEgypt
Study dates: 25 Oct 2018to 1 Oct 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Egypt1 site

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

Other trials in Egypt

About this study

Read the 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.

Conditions: Pain, Acute
Being tested: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block., Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block., Control
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.Procedure or surgery
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.
Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.Procedure or surgery
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.
ControlProcedure or surgery
Conventional analgesia

Study groups in NCT04029987
Study group	Role	What they receive
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. Receives: 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. Receives: 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 Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: starting after the block is given up to the first 12 hours post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 20181 Oct 2019

First posted23 Jul 2019
Study start25 Oct 2018
Primary completion1 Oct 2019
Study completion1 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, AcuteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04029987
Sponsor's protocol ID: N-31-2018
Status last verified: Jan 2020
First submitted: 2 Dec 2018
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04029987
Acronym / sponsor ID: N-31-2018
Conditions: Pain, Acute
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Kasr El Aini HospitalUniversity, hospital or other
Study start: 25 Oct 2018 (actual)
Primary completion: 1 Oct 2019 (actual)
Study completion: 1 Oct 2019 (actual)
First posted: 23 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
Trans Muscular Quadratus Lumborum fascial plane Block	Active comparator	Procedure: Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum 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.
Intra Muscular Quadratus Lumborum fascial plane Block	Active comparator	Procedure: Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum 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 c → control	Placebo comparator	Procedure: Controlgroup 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

Who may qualify

Ages: 5 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

Refusal of regional block or patients requiring emergency procedures.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Procedure or surgery	Trans Muscular Quadratus Lumborum fascial plane Block
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.	Procedure or surgery	Intra Muscular Quadratus Lumborum fascial plane Block
ControlConventional analgesia	Procedure or surgery	group c → control

Primary outcome

Time of the first postoperative analgesic request
Time frame: starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours
(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.

6 secondary outcomes

total opioid consumption over the first 12 hours.
Time frame: through out the first 12 hours post operative.
Pain score up to 12 hours after surgery.
Time frame: through out the first 12 hours post operative.
Block failure
Time frame: through out the first hour post operative.
Ease of performance of each technique
Time frame: through out the block performance time
Block performance time
Time frame: starting from probe contact with skin till 30 minutes.
The incidence of post block adverse effects
Time frame: starting after the block is given up to the first 12 hours post operative

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of the first postoperative analgesic request (time frame: starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04029987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.