AnalgesiaNCT04354571
Erector Spinae Plane Block in Pediatric Hip Surgery
A study testing Erector spinae plane block and caudal block in people with Analgesia, run by Alexandria University at 1 site in Egypt.
Trial summary
Hip Surgery in pediatric patients is considered an extremely painful procedure. Managing pain in this surgery is challenging even with several available options, each with limitations. Erector spinae plane (ESP) block is a novel technique that has been used in different types of surgery, with promising results. Read more about this study
- Who is it for?
- Ages 2 to 7 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
- 11 Aug 2019to Sep 2020
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I II scheduled for hip surgery.
Who cannot join
- • Parent refusal
- Coagulopathy
- Patient with congenital heart disease
- Infection at the site of puncture
- Significant spinal anatomical anomaly
- Patient with neuromuscular disorder
- Any known allergy to the drug used
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria
yasser osman, 01006357996, yasseralx@hotmail.com
rbab saber, asst prof
About this study
Official title: Evaluation of Post Operative Analgesia of the Erector Spinae Plane Block in Pediatric Patients Undergoing Hip Surgery: a Randomized Control Trial
Hip Surgery in pediatric patients is considered an extremely painful procedure. Managing pain in this surgery is challenging even with several available options, each with limitations. Erector spinae plane (ESP) block is a novel technique that has been used in different types of surgery, with promising results. Many case reports for use of ESPB are available in the literature but to our knowledge, no cohort studies or randomized controlled trials have been performed on ESPB for hip surgery in pediatrics age group against a traditional method as caudal block.1,2 AIM OF WORK
. The Primary outcome of this study is to compare the efficacy of analgesia resulting from the Erector spinae plane block versus the caudal block in pediatric patients undergoing hip surgery using the FLACC score and the duration of the analgesia of both methods till the first rescue analgesic.
The Secondary outcome is to compare the analgesic rescue frequency and total dose given in both groups as well as comparing the complications that might occur from each analgesic technique.
- 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
An ultrasound-guided Erector spinae plane block was performed with the patient lying on the his side and the surgical side on the top. After skin disinfection, sterile draping was be placed and the ultrasound probe was sheathed. The level of the block was the transverse process of L2. The block was performed using a 9-12 MHz linear probe (LOGIQe, GE Healthcare, USA), which was placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) was identified, and a 22 G, 50 mm insulated needle (Sonoplex Stim, Pajunk, Germany) was inserted cranio-caudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 ml/kg of 0.25% bupivacaine was injected to confirm the correct position by visualizing the solution lifting the ESM off the transverse process.
caudal blockProcedure or surgery
caudal block was performed using anatomical landmarks and ultrasound guided and confirmed with a concentration of bupivacaine of 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| GROUP (Erector spinae block): | Experimental | were given general anesthesia plus Erector spinae plane block Receives: Procedure: Erector spinae plane block |
| GROUP (caudal block): | Active comparator | were given general anesthesia plus caudal block Receives: Procedure: caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Pain was assessed using face, legs, activity, and cry consolability scale [FLACC] 1-10 1 is no pain and 10 is the worst pain.
Measured: 1 day .
Secondary outcomes (1)
complications
not any complication related to the block
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start11 Aug 2019
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Mohamed Osman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354571
- Sponsor's protocol ID
- 1234
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Operative Analgesia of the Erector Spinae Plane Block in Pediatric Patients Undergoing Hip Surgery: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04354571
- Acronym / sponsor ID
- 1234
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 11 Aug 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 21 Apr 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.
Hip Surgery in pediatric patients is considered an extremely painful procedure. Managing pain in this surgery is challenging even with several available options, each with limitations. Erector spinae plane (ESP) block is a novel technique that has been used in different types of surgery, with promising results. Many case reports for use of ESPB are available in the literature but to our knowledge, no cohort studies or randomized controlled trials have been performed on ESPB for hip surgery in pediatrics age group against a traditional method as caudal block.1,2 AIM OF WORK
. The Primary outcome of this study is to compare the efficacy of analgesia resulting from the Erector spinae plane block versus the caudal block in pediatric patients undergoing hip surgery using the FLACC score and the duration of the analgesia of both methods till the first rescue analgesic.
The Secondary outcome is to compare the analgesic rescue frequency and total dose given in both groups as well as comparing the complications that might occur from each analgesic technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP (Erector spinae block): | Experimental | Procedure: Erector spinae plane blockwere given general anesthesia plus Erector spinae plane block |
| GROUP (caudal block): | Active comparator | Procedure: caudal blockwere given general anesthesia plus caudal block |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA I II scheduled for hip surgery.
Key exclusion criteria (7 listed)
- • Parent refusal
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 blockAn ultrasound-guided Erector spinae plane block was performed with the patient lying on the his side and the surgical side on the top. After skin disinfection, sterile draping was be placed and the ultrasound probe was sheathed. The level of the block was the transverse process of L2. The block was performed using a 9-12 MHz linear probe (LOGIQe, GE Healthcare, USA), which was placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) was identified, and a 22 G, 50 mm insulated needle (Sonoplex Stim, Pajunk, Germany) was inserted cranio-caudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 ml/kg of 0.25% bupivacaine was injected to confirm the correct position by visualizing the solution lifting the ESM off the transverse process. | Procedure or surgery | GROUP (Erector spinae block): |
| caudal blockcaudal block was performed using anatomical landmarks and ultrasound guided and confirmed with a concentration of bupivacaine of 0.25%. | Procedure or surgery | GROUP (caudal block): |
Primary outcome
Pain assessment
Time frame: 1 day .
Pain was assessed using face, legs, activity, and cry consolability scale [FLACC] 1-10 1 is no pain and 10 is the worst pain.
1 secondary outcome
complications
Time frame: through study completion, an average of 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 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.
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 Alexandria 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 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 1 day .). 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 Apr 2020.