AnalgesiaNCT05153720
Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients
A study testing Erector spinae plane block and Caudal block in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The study aim to compare ultrasound guided erector spinae plane block versus ultrasound guided caudal block in perioperative analgesia for pediatric cancer patients Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Erector spinae plane block and Caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2021to 29 Jul 2024
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I and II
- Age >1 and <12
- patients undergoing nephrectomy surgeries
Who cannot join
- patients parental refusal
- local infection at the puncture site
- coagulopathy with INR> 1.6
- unstable cardiovascular disease
- patients allergic to medication used
- development or mental delay
- impaired liver and renal functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound Guided Erector Spinae Block and Ultrasound Guided Caudal for Perioperative Analgesia in Pediatric Cancer Patients Undergoing Nephrectomy Surgeries: a Randomized Controlled Study
The study aim to compare ultrasound guided erector spinae plane block versus ultrasound guided caudal block in perioperative analgesia for pediatric cancer patients
- Conditions
- Analgesia
- Being tested
- Erector spinae plane 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.
Erector spinae plane blockProcedure or surgery
Ultrasound guided erector spinae plane block
Caudal blockProcedure or surgery
Ultrasound guided caudal block
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided erector spinae plane block | Experimental | Unilateral erector spinae plane block will be performed under ultrasound guidance Receives: Procedure: Erector spinae plane block |
| Ultrasound guided caudal block | Active comparator | Caudal block will be formed under ultrasound guidance Receives: Procedure: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
postoperative morphine consumption
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start20 Dec 2021
- Primary completion26 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo UniversityYasmen F Abdelghani, M.Sc, Principal investigator, Assistant Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153720
- Sponsor's protocol ID
- AP2109-30109
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2021
- Last updated
- 24 Sep 2024
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Erector Spinae Block and Ultrasound Guided Caudal for Perioperative Analgesia in Pediatric Cancer Patients Undergoing Nephrectomy Surgeries: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05153720
- Acronym / sponsor ID
- AP2109-30109
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 10 Dec 2021 (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 study aim to compare ultrasound guided erector spinae plane block versus ultrasound guided caudal block in perioperative analgesia for pediatric cancer patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided erector spinae plane block | Experimental | Procedure: Erector spinae plane blockUnilateral erector spinae plane block will be performed under ultrasound guidance |
| Ultrasound guided caudal block | Active comparator | Procedure: Caudal blockCaudal block will be formed under ultrasound guidance |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I and II
- Age >1 and <12
- patients undergoing nephrectomy surgeries
Key exclusion criteria (7 listed)
- patients parental refusal
- local infection at the puncture site
- coagulopathy with INR> 1.6
- unstable cardiovascular disease
- patients allergic to medication used
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 |
|---|---|---|
| Erector spinae plane blockUltrasound guided erector spinae plane block | Procedure or surgery | Ultrasound guided erector spinae plane block |
| Caudal blockUltrasound guided caudal block | Procedure or surgery | Ultrasound guided caudal block |
Primary outcome
opioid consumption
Time frame: First 24 hours postoperatively
postoperative morphine consumption
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 24 Sep 2024.
- 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.
Walaa Y Elsabeeny, MD principal investigator
Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
Yasmen F Abdelghani, M.Sc principal investigator
Assistant Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and Caudal block in people with Analgesia, run by National Cancer Institute, Egypt 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 7 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 24 Sep 2024. 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?
opioid consumption (time frame: First 24 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 24 Sep 2024.