Pain ManagementNCT04269460
Ultrasound Guided Subcostal Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pediatrics Undergoing Pyeloplasty.
A study testing Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] in people with Pain Management and Pediatrics, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The aim of this work to compare the analgesic efficacy of preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block in pediatric patients undergoing pyeloplasty surgeries. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Pain Management, Pediatrics, Anesthesia
- What is being tested?
- Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 1 Mar 2021
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesia (ASA) physical status I-II.
- Age: 3 months to 5 years.
- Undergoing pyeloplasty surgeries.
Who cannot join
- Refusal of parents.
- Patients with coagulation disorders (INR > 1.5 and/or platelets < 100 000).
- History of allergic reactions to local anesthetics.
- Rash or signs of infection at the injection site.
- Emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound Guided Subcostal Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pediatrics Undergoing Pyeloplasty.
The aim of this work to compare the analgesic efficacy of preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block in pediatric patients undergoing pyeloplasty surgeries.
Read the detailed description
This randomized, controlled study is designed to:
- Assess the quality of perioperative analgesia (intraoperative hemodynamics, postoperative pain score and analgesic consumption) provided by ultrasound guided subcostal TAP and quadratus lumborum blocks in pediatrics undergoing pyeloplasty surgeries.
- Compare the efficacy and safety of both blocks in pediatrics undergoing pyeloplasty surgery.
Hypothesis
Following approval from research and ethics committee of anesthesia department, Faculty of Medicine, Cairo University, children will be pre-medicated by intramuscular injection of atropine 0.02 mg/Kg, midazolam 0.2 mg/Kg and ketamine 2 mg/ Kg before admission to operation theater (OR).
Upon arrival to OR; continuous electrocardiography (ECG), pulse oximetry, non-invasive arterial blood pressure will be applied and baseline readings will be recorded, then general anesthesia will be induced by 8% sevoflurane and 50% air in oxygen. Peripheral venous cannula will be inserted after loss of consciousness. If a patient had an intravenous (IV) cannula, induction will be performed using 1.5-2.5 mg/kg propofol, in both situations atracurium at a dose of 0.5 mg/kg will be given intravenously to facilitate endotracheal intubation and fentanyl at a dose 2 µg/kg will be given to abolish stress response of intubation. Anesthesia will be maintained by using 1-1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes.
Patient positioning and preparation for the block:
For the (sTAP) group (n=39): patients will be in the supine position; after preparing the skin with with povidone iodine, a high frequency (5-10 MHz) ultrasound probe will be placed obliquely on the upper abdominal wall, along the surgical site subcostal margin near the midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally along the subcostal margin until we identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in-plane technique will be inserted medially near the xiphoid process aiming towards the iliac crest, then 1 mL/Kg of bupivacaine 0.25% will be injected in the plane between rectus abdominis and transversus abdominis muscles. The patient will then be positioned for the procedure if other than supine position is chosen.
For the (QLB) group (n=39): patients will be positioned in the lateral decubitus position so that the blocked side will be the uppermost one. After skin sterilization with povidone iodine the ultrasound probe will be positioned between the iliac crest and the costal margin at the level of the anterior axillary line to identify the three thin parallel muscles of the anterolateral abdominal wall. The probe will be moved posteriorly following the narrowing of the muscles until the muscle fibers of transversus abdominis muscles taper off into its aponeurosis at the level of the posterior axillary line where the quadratus lumborum muscle is identified. The posterior aspect of the QL muscle is confirmed and a 22 G echogenic needle will be inserted using an in-plane technique from anterolateral to posteromedial towards this posterior aspect of the QL muscle. 1 mL/Kg of bupivacaine 0.25% will be injected behind the QL muscle on the lateral border of the erector spinae muscle. The patient will then be positioned for the procedure if other than lateral decubitus position is chosen.
Vital signs (heart rate (HR) and non-invasive blood pressure) will be recorded at the onset of the block then every 15 minutes intraoperatively, and every 4 hours postoperatively for a period of 24 hours. Fentanyl 0.5 µg /kg as rescue analgesia will be given intraoperatively if HR and or systolic BP increased >20% of baseline up to maximum 5 µg/ kg.
After skin closure, inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered IV after return of patient's spontaneous breathing. Patients will then be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and monitoring.
Postoperative assessment and analgesic regimen:
The Face, Legs, Activity, Cry, Consolability scale (FLACC) (table 1) will be assessed immediately postoperative in the PACU and every 4 hours in the ward for 24 hours. The time to the first request of rescue postoperative analgesic will be: "the time interval between the local anesthesia injection and the first request to postoperative analgesia (patients first complain of pain and or FLACC score ≥4)". an intravenous paracetamol 15mg/kg will be given immediately postoperative and will be repeated every 6 hours. Persistent or breakthrough pain will be managed with incremental intravenous morphine at a dose of 0.05-0.1mg/kg to maintain resting FLACC scale ˂ 4 (maximum dose 0.3mg/kg). Cumulative 24 hours analgesic consumption will be recorded.
- Conditions
- Pain Management, Pediatrics, Anesthesia
- Being tested
- Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]
- Keywords
- ultrasound, quadratus lumborum, subcostal TAP, pediatrics, pyeloplasty
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]Drug
preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block using 1 ml/kg of Bupivacaine Hydrochloride 0.25%in pediatric patients undergoing pyeloplasty surgeries.
| Study group | Role | What they receive |
|---|---|---|
| subcostal transversus abdominis plane block (sTAP) | Active comparator | patients will be in the supine position; after preparing the skin with with povidone iodine, a high frequency (5-10 MHz) ultrasound probe will be used tp identify the rectus abdominis muscle, then 1 mL/Kg of bupivacaine 0.25% will be injected in the plane between rectus abdominis and transversus abdominis muscles.The patient will then be positioned for the procedure if other than supine position is chosen. Receives: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] |
| quadratus lumborum block (QLB) | Active comparator | patients will be positioned in the lateral decubitus position so that the blocked side will be the uppermost one. After skin sterilization with povidone iodine the ultrasound probe will be positioned to identify the quadratus lumborum muscle. then 1 mL/Kg of bupivacaine 0.25% will be injected behind the QL muscle on the lateral border of the erector spinae muscle.The patient will then be positioned for the procedure if other than lateral decubitus position is chosen. Receives: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale at 12 hours
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 24 hours
Secondary outcomes (3)
• Time to first request of postoperative rescue analgesics
the time interval between the local anesthesia injection and the first request to postoperative analgesia (patients first complain of pain and or FLACC score ≥4.
Measured: 24 hours
• Total consumption of opioids
Measured: 24 hours
• Block performance time
time from probe contact with skin till needle withdrawal.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Feb 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269460
- Sponsor's protocol ID
- D-41-2019
- Status last verified
- Mar 2021
- First submitted
- 11 Feb 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Subcostal Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pediatrics Undergoing Pyeloplasty.
- ClinicalTrials.gov ID
- NCT04269460
- Acronym / sponsor ID
- D-41-2019
- Conditions
- Pain Management, Pediatrics, Anesthesia
- Keywords
- ultrasound, quadratus lumborum, subcostal TAP, pediatrics, pyeloplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Feb 2020 (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.
The aim of this work to compare the analgesic efficacy of preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block in pediatric patients undergoing pyeloplasty surgeries.
Detailed description
This randomized, controlled study is designed to:
- Assess the quality of perioperative analgesia (intraoperative hemodynamics, postoperative pain score and analgesic consumption) provided by ultrasound guided subcostal TAP and quadratus lumborum blocks in pediatrics undergoing pyeloplasty surgeries.
- Compare the efficacy and safety of both blocks in pediatrics undergoing pyeloplasty surgery.
Hypothesis
Following approval from research and ethics committee of anesthesia department, Faculty of Medicine, Cairo University, children will be pre-medicated by intramuscular injection of atropine 0.02 mg/Kg, midazolam 0.2 mg/Kg and ketamine 2 mg/ Kg before admission to operation theater (OR).
Upon arrival to OR; continuous electrocardiography (ECG), pulse oximetry, non-invasive arterial blood pressure will be applied and baseline readings will be recorded, then general anesthesia will be induced by 8% sevoflurane and 50% air in oxygen. Peripheral venous cannula will be inserted after loss of consciousness. If a patient had an intravenous (IV) cannula, induction will be performed using 1.5-2.5 mg/kg propofol, in both situations atracurium at a dose of 0.5 mg/kg will be given intravenously to facilitate endotracheal intubation and fentanyl at a dose 2 µg/kg will be given to abolish stress response of intubation. Anesthesia will be maintained by using 1-1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes.
Patient positioning and preparation for the block:
For the (sTAP) group (n=39): patients will be in the supine position; after preparing the skin with with povidone iodine, a high frequency (5-10 MHz) ultrasound probe will be placed obliquely on the upper abdominal wall, along the surgical site subcostal margin near the midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally along the subcostal margin until we identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in-plane technique will be inserted medially near the xiphoid process aiming towards the iliac crest, then 1 mL/Kg of bupivacaine 0.25% will be injected in the plane between rectus abdominis and transversus abdominis muscles. The patient will then be positioned for the procedure if other than supine position is chosen.
For the (QLB) group (n=39): patients will be positioned in the lateral decubitus position so that the blocked side will be the uppermost one. After skin sterilization with povidone iodine the ultrasound probe will be positioned between the iliac crest and the costal margin at the level of the anterior axillary line to identify the three thin parallel muscles of the anterolateral abdominal wall. The probe will be moved posteriorly following the narrowing of the muscles until the muscle fibers of transversus abdominis muscles taper off into its aponeurosis at the level of the posterior axillary line where the quadratus lumborum muscle is identified. The posterior aspect of the QL muscle is confirmed and a 22 G echogenic needle will be inserted using an in-plane technique from anterolateral to posteromedial towards this posterior aspect of the QL muscle. 1 mL/Kg of bupivacaine 0.25% will be injected behind the QL muscle on the lateral border of the erector spinae muscle. The patient will then be positioned for the procedure if other than lateral decubitus position is chosen.
Vital signs (heart rate (HR) and non-invasive blood pressure) will be recorded at the onset of the block then every 15 minutes intraoperatively, and every 4 hours postoperatively for a period of 24 hours. Fentanyl 0.5 µg /kg as rescue analgesia will be given intraoperatively if HR and or systolic BP increased >20% of baseline up to maximum 5 µg/ kg.
After skin closure, inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered IV after return of patient's spontaneous breathing. Patients will then be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and monitoring.
Postoperative assessment and analgesic regimen:
The Face, Legs, Activity, Cry, Consolability scale (FLACC) (table 1) will be assessed immediately postoperative in the PACU and every 4 hours in the ward for 24 hours. The time to the first request of rescue postoperative analgesic will be: "the time interval between the local anesthesia injection and the first request to postoperative analgesia (patients first complain of pain and or FLACC score ≥4)". an intravenous paracetamol 15mg/kg will be given immediately postoperative and will be repeated every 6 hours. Persistent or breakthrough pain will be managed with incremental intravenous morphine at a dose of 0.05-0.1mg/kg to maintain resting FLACC scale ˂ 4 (maximum dose 0.3mg/kg). Cumulative 24 hours analgesic consumption will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subcostal transversus abdominis plane block (sTAP) | Active comparator | Drug: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]patients will be in the supine position; after preparing the skin with with povidone iodine, a high frequency (5-10 MHz) ultrasound probe will be used tp identify the rectus abdominis muscle, then 1 mL/Kg of bupivacaine 0.25% will be injected in the plane between rectus abdominis and transversus abdominis muscles.The patient will then be positioned for the procedure if other than supine position is chosen. |
| quadratus lumborum block (QLB) | Active comparator | Drug: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]patients will be positioned in the lateral decubitus position so that the blocked side will be the uppermost one. After skin sterilization with povidone iodine the ultrasound probe will be positioned to identify the quadratus lumborum muscle. then 1 mL/Kg of bupivacaine 0.25% will be injected behind the QL muscle on the lateral border of the erector spinae muscle.The patient will then be positioned for the procedure if other than lateral decubitus position is chosen. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesia (ASA) physical status I-II.
- Age: 3 months to 5 years.
- Undergoing pyeloplasty surgeries.
Key exclusion criteria (5 listed)
- Refusal of parents.
- Patients with coagulation disorders (INR > 1.5 and/or platelets < 100 000).
- History of allergic reactions to local anesthetics.
- Rash or signs of infection at the injection site.
- Emergency surgery.
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 |
|---|---|---|
| Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block using 1 ml/kg of Bupivacaine Hydrochloride 0.25%in pediatric patients undergoing pyeloplasty surgeries. | Drug | quadratus lumborum block (QLB), subcostal transversus abdominis plane block (sTAP) |
Primary outcome
Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale at 12 hours
Time frame: 24 hours
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
3 secondary outcomes
• Time to first request of postoperative rescue analgesics
Time frame: 24 hours
• Total consumption of opioids
Time frame: 24 hours
• Block performance time
Time frame: 24 hours
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 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] in people with Pain Management and Pediatrics, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 inclusion and 5 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 16 Mar 2021. 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. 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?
Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale at 12 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2021.