Analgesia , Open Renal SurgeriesNCT05289401
Analgesic Effect of Ultrasound Guided Errector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Open Renal Surgeries.
A study testing ultrasound guided blocks in people with Analgesia , Open Renal Surgeries, run by Cairo University at 1 site in Egypt.
Trial summary
comparison between the erector spinae block and caudal block with the aid of the of ultra sound in children as regard time of request of rescue analgesia , degree of intra and post operative pain relief , effect of hemodynamic stability and incidences of complication in open renal surgeries . Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Analgesia , Open Renal Surgeries
- What is being tested?
- ultrasound guided blocks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Mar 2022
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 2-6 years old.
- American society of anesthesiologists classification (ASA) I and II .
- Patients undergoing unilateral open renal surgeries.
Who cannot join
- Refusal of block.
- Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%).
- Skin lesion, wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs.
- Contraindications to neuraxial block as sepsis, severe aortic stenosis, increased intracranial pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Ultrasound Guided Errector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
comparison between the erector spinae block and caudal block with the aid of the of ultra sound in children as regard time of request of rescue analgesia , degree of intra and post operative pain relief , effect of hemodynamic stability and incidences of complication in open renal surgeries .
Read the detailed description
Open Renal surgeries (pyeloplasty and nephrectomy) is associated with significant postoperative pain. Adequate postoperative analgesia is important to allow for early mobilization and discharge of the patients .Systemic opioids are usually not sufficient for pain control after renal surgeries in children. The use of opioid in pediatrics has many side effects such as somnolence, vomiting, and up to respiratory depression.
Neuraxial analgesia is usually required in these operations in combination with general anesthesia. Neuraxial analgesia decreases morbidity, mortality, opiate exposure, shortens post anesthesia recovery room time and hospital stay. However, it is usually associated with many complications as urinary retention and excessive motor block.
Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. It can be used for analgesia in different renal surgeries providing adequate pain relief in the post- operative period .
Paediatric regional anaesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anaesthetic practice. It offers many advantages to both the patient and the hospital. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids without the complications of neuraxial anesthesia. Considerable progress has been made in the practice of PRA over the past few years including availability of information on safety and incorporation of ultrasound guidance. Novel regional anaesthesia (RA) techniques, especially the anterolateral and the posterolateral trunk blocks, show promise .
The erector spinae plane block (ESPB), one of the posterolateral trunk blocks, was first described by Forero et al. in 2016 and has been used by many anaesthesiologists for perioperative pain relief 4. Its mechanism of action is spreading of local anesthetic into multiple paravertebral spaces after injection into the interfascial space between the transverse process of the vertebrae and the erector spinae muscle. It can be used for postoperative analgesia for longer period and decrease the use of opioids with less complications in several pediatric surgeries including nephrectomy and pyeloplasty.
For this reason, ESPB efficacy will be compared to the caudal block efficacy seeking for a simple, safe and effective regional analgesic technique for renal surgeries in children.
Electrical Cardiometry is a method for the non-invasive determination of stroke volume (SV), cardiac output (CO), stroke volume variation (SVV) and other hemodynamic parameters in adults, children, and neonates and it has been validated against "gold standard" methods such as thermodilution. Several potential mechanisms have been suggested for the action of the ESPB such as paravertebral spread as well as epidural spread of local anesthetic. These mechanisms raise the concern of the possible negative hemodynamic consequences of the ESPB which were not properly investigated .
- Conditions
- Analgesia , Open Renal Surgeries
- Being tested
- ultrasound guided blocks
- Keywords
- erector spinae block , caudal block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided blocksOther
Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric
| Study group | Role | What they receive |
|---|---|---|
| ESPB | Active comparator | Unilateral erector spinae block will be performed in the lateral position . 0.5 mL/Kg of bupivacaine 0.125% will be injected taking care not to exceed the maximum recommended dose (2 mg/kg of bupivacaine) Receives: Other: ultrasound guided blocks |
| CB | Active comparator | caudal block performed in lateral position . bolus of 1.2 ml/Kg bupivacaine 0.125% . Receives: Other: ultrasound guided blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
The first time to require rescue analgesia in minutes (from the time of erector spinae block or caudal injection to the first registration of CHEOPS pain score more than 6)
Measured: at the time of transfer from PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours postoperatively
Secondary outcomes (1)
secondary outcome
Total analgesia consumption in each group in the first 12 hours post-operative period
Measured: at time of transfer to PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Jan 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia , Open Renal SurgeriesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chahenda Salem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289401
- Sponsor's protocol ID
- MD-323-2020
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 21 Mar 2022
- Results posted
- 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 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Ultrasound Guided Errector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT05289401
- Acronym / sponsor ID
- MD-323-2020
- Conditions
- Analgesia , Open Renal Surgeries
- Keywords
- erector spinae block , caudal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 Mar 2022 (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.
comparison between the erector spinae block and caudal block with the aid of the of ultra sound in children as regard time of request of rescue analgesia , degree of intra and post operative pain relief , effect of hemodynamic stability and incidences of complication in open renal surgeries .
Detailed description
Open Renal surgeries (pyeloplasty and nephrectomy) is associated with significant postoperative pain. Adequate postoperative analgesia is important to allow for early mobilization and discharge of the patients .Systemic opioids are usually not sufficient for pain control after renal surgeries in children. The use of opioid in pediatrics has many side effects such as somnolence, vomiting, and up to respiratory depression.
Neuraxial analgesia is usually required in these operations in combination with general anesthesia. Neuraxial analgesia decreases morbidity, mortality, opiate exposure, shortens post anesthesia recovery room time and hospital stay. However, it is usually associated with many complications as urinary retention and excessive motor block.
Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. It can be used for analgesia in different renal surgeries providing adequate pain relief in the post- operative period .
Paediatric regional anaesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anaesthetic practice. It offers many advantages to both the patient and the hospital. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids without the complications of neuraxial anesthesia. Considerable progress has been made in the practice of PRA over the past few years including availability of information on safety and incorporation of ultrasound guidance. Novel regional anaesthesia (RA) techniques, especially the anterolateral and the posterolateral trunk blocks, show promise .
The erector spinae plane block (ESPB), one of the posterolateral trunk blocks, was first described by Forero et al. in 2016 and has been used by many anaesthesiologists for perioperative pain relief 4. Its mechanism of action is spreading of local anesthetic into multiple paravertebral spaces after injection into the interfascial space between the transverse process of the vertebrae and the erector spinae muscle. It can be used for postoperative analgesia for longer period and decrease the use of opioids with less complications in several pediatric surgeries including nephrectomy and pyeloplasty.
For this reason, ESPB efficacy will be compared to the caudal block efficacy seeking for a simple, safe and effective regional analgesic technique for renal surgeries in children.
Electrical Cardiometry is a method for the non-invasive determination of stroke volume (SV), cardiac output (CO), stroke volume variation (SVV) and other hemodynamic parameters in adults, children, and neonates and it has been validated against "gold standard" methods such as thermodilution. Several potential mechanisms have been suggested for the action of the ESPB such as paravertebral spread as well as epidural spread of local anesthetic. These mechanisms raise the concern of the possible negative hemodynamic consequences of the ESPB which were not properly investigated .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB | Active comparator | Other: ultrasound guided blocksUnilateral erector spinae block will be performed in the lateral position . 0.5 mL/Kg of bupivacaine 0.125% will be injected taking care not to exceed the maximum recommended dose (2 mg/kg of bupivacaine) |
| CB | Active comparator | Other: ultrasound guided blockscaudal block performed in lateral position . bolus of 1.2 ml/Kg bupivacaine 0.125% . |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients 2-6 years old.
- American society of anesthesiologists classification (ASA) I and II .
- Patients undergoing unilateral open renal surgeries.
Key exclusion criteria (5 listed)
- Refusal of block.
- Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%).
- Skin lesion, wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs.
- Contraindications to neuraxial block as sepsis, severe aortic stenosis, increased intracranial pressure.
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 |
|---|---|---|
| ultrasound guided blocksUltrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric | Other | CB, ESPB |
Primary outcome
primary outcome
Time frame: at the time of transfer from PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours postoperatively
The first time to require rescue analgesia in minutes (from the time of erector spinae block or caudal injection to the first registration of CHEOPS pain score more than 6)
1 secondary outcome
secondary outcome
Time frame: at time of transfer to PACU and then at 1, 2, 3, 4, 6, 8 and 12 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 21 Mar 2022.
- 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 ultrasound guided blocks in people with Analgesia , Open Renal Surgeries, run by Cairo University 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 21 Mar 2022. 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?
primary outcome (time frame: at the time of transfer from PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours postoperatively). 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 21 Mar 2022.