Post Operative PainPhase 3NCT05157516
Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients
A Phase 3 study testing erector spinea block and Caudal epidural block in people with Post Operative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- erector spinea block and Caudal epidural block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Dec 2021to 28 Jun 2022
- Phase
- Phase 3
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II.
- Scheduled to undergo hip or proximal femur surgeries.
Who cannot join
- Refusal of participation by parents or caregivers
- Known local anesthetic (LA) drug sensitivity
- Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3.
- Skin lesions or wounds at the site of proposed needle insertion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study
The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients
- Conditions
- Post Operative Pain
- Being tested
- erector spinea block, Caudal epidural block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinea blockProcedure or surgery
the patients will receive a single injection erector spinea block after induction of general anesthesia
Caudal epidural blockProcedure or surgery
the patients will receive caudal epidural block after induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group ESPB | Active comparator | Erector Spinae Plane Block Receives: Procedure: erector spinea block |
| In group CEA | Active comparator | Caudal epidural block Receives: Procedure: Caudal epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
By using face, legs, activity, and cry consolability scale [FLACC ]
FLACC scale will be measured as following:
Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10.
Assessment of the final score:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Measured: 2 hours post-operatively
Secondary outcomes (6)
pain scores
By using face, legs, activity, and cry consolability scale [FLACC ]
FLACC scale will be measured as following:
Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10.
Assessment of the final score:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Measured: at 2 hour intervals during the first 24 hours postoperatively
Block failure rate
The block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively
Measured: First hour postoperatively
Block performance time
Measured: Preoperative
The incidence of adverse effects
Measured: Up to one week after the block
Duration of the block
Measured: UP to 48 hours postoperatively
Degree of contralateral motor blockage and lower limb weakness
By using modified bromage scale as following:
Grade I : Free movement of legs and feet Degree of block :Nil (0%)
Grade II :Just able to flex knees with free movement of feet Degree of block :Partial (33%)
Grade III :Unable to flex knees, but with free movement of feet Degree of block: Almost complete (66%)
Grade IV :Unable to move legs or feet Degree of block: Complete (100%)
Measured: UP to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start21 Dec 2021
- Primary completion2 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157516
- Sponsor's protocol ID
- MD-340-2020
- Status last verified
- Jul 2022
- First submitted
- 28 Sep 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05157516
- Acronym / sponsor ID
- MD-340-2020
- Conditions
- Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 15 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 will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group ESPB | Active comparator | Procedure: erector spinea blockErector Spinae Plane Block |
| In group CEA | Active comparator | Procedure: Caudal epidural blockCaudal epidural block |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I-II.
- Scheduled to undergo hip or proximal femur surgeries.
Key exclusion criteria (4 listed)
- Refusal of participation by parents or caregivers
- Known local anesthetic (LA) drug sensitivity
- Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3.
- Skin lesions or wounds at the site of proposed needle insertion.
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 spinea blockthe patients will receive a single injection erector spinea block after induction of general anesthesia | Procedure or surgery | group ESPB |
| Caudal epidural blockthe patients will receive caudal epidural block after induction of general anesthesia | Procedure or surgery | In group CEA |
Primary outcome
Pain score
Time frame: 2 hours post-operatively
By using face, legs, activity, and cry consolability scale [FLACC ] FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10. Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
6 secondary outcomes
pain scores
Time frame: at 2 hour intervals during the first 24 hours postoperatively
Block failure rate
Time frame: First hour postoperatively
Block performance time
Time frame: Preoperative
The incidence of adverse effects
Time frame: Up to one week after the block
Duration of the block
Time frame: UP to 48 hours postoperatively
Degree of contralateral motor blockage and lower limb weakness
Time frame: UP to 48 hours postoperatively
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 18 Jul 2022.
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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 Phase 3 study testing erector spinea block and Caudal epidural block in people with Post Operative Pain, 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 2 inclusion and 4 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 18 Jul 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain score (time frame: 2 hours post-operatively). 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 18 Jul 2022.