Erector Spinae Plane BlockNCT06600061
Bilateral Erector Spinae Plane Block as an Opioid Sparing Technique for Selective Dorsal Rhizotomy in Pediatric Patients With Spastic Cerebral Palsy
A study testing Erector Spinae Plane Block in people with Erector Spinae Plane Block and Opioid, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy of bilateral erector spinae plane block as an opioid-sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Erector Spinae Plane Block, Opioid, Sparing
- What is being tested?
- Erector Spinae Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2024to 15 Oct 2025
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age from 6 to 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II, III.
- Patients with spastic cerebral palsy undergoing selective dorsal rhizotomy.
Who cannot join
- Allergy to local anesthetics.
- Severe fixed joint deformity.
- Previous orthopedic surgery.
- Patient with abnormal liver/kidney function.
- Patient with skin damage or infection at the proposed puncture site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Erector Spinae Plane Block as an Opioid Sparing Technique for Selective Dorsal Rhizotomy in Pediatric Patients With Spastic Cerebral Palsy: A Randomized Controlled Trial
This study aims to evaluate the efficacy of bilateral erector spinae plane block as an opioid-sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy.
Read the detailed description
Cerebral palsy (CP) is the most common physical disability affecting children. Selective dorsal rhizotomy (SDR) is a neurosurgical procedure that permanently reduces lower limb spasticity in children with CP by selectively targeting and removing sensory rootlets with aberrant activity.
Postoperative pain is often distressing for patients and their families and can result in complications, delayed participation in therapy, and poor functional recovery. Erector spinae plane block (ESPB) is a newly described interfascial plane block. ESPB is effective on both visceral and somatic pain.
- Conditions
- Erector Spinae Plane Block, Opioid, Sparing, Selective Dorsal Rhizotomy, Pediatric, Spastic Cerebral Palsy
- Being tested
- Erector Spinae Plane Block
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
Patients will receive erector spinae plane block after induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block group | Experimental | Patients will receive erector spinae plane block after induction of anesthesia. Receives: Other: Erector Spinae Plane Block |
| Control group | No intervention | Patients will not receive erector spinae plane block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of 0.05 mg/kg morphine will be given if the Wong-Baker score is 4 more to be repeated after 30 min if pain persists until the Wong-Baker score < 4.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to the first dose of morphine administrated) will be assessed.
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the Wong-Baker pain rating scale (The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"). Wong-Baker score will be assessed at post anesthesia care unit, 4, 6, 8, 12, 18 and 24 h postoperatively.
Measured: 24 hours postoperatively
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as Local anesthetic systemic toxicity (LAST), bradycardia, hypotension, postoperative nausea and vomiting (PONV), respiratory depression, or any other complication will be recorded.
Measured: 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 posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600061
- Sponsor's protocol ID
- 36264PR838/9/24
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Erector Spinae Plane Block as an Opioid Sparing Technique for Selective Dorsal Rhizotomy in Pediatric Patients With Spastic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06600061
- Acronym / sponsor ID
- 36264PR838/9/24
- Conditions
- Erector Spinae Plane Block, Opioid, Sparing, Selective Dorsal Rhizotomy, Pediatric, Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 19 Sep 2024 (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.
This study aims to evaluate the efficacy of bilateral erector spinae plane block as an opioid-sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy.
Detailed description
Cerebral palsy (CP) is the most common physical disability affecting children. Selective dorsal rhizotomy (SDR) is a neurosurgical procedure that permanently reduces lower limb spasticity in children with CP by selectively targeting and removing sensory rootlets with aberrant activity.
Postoperative pain is often distressing for patients and their families and can result in complications, delayed participation in therapy, and poor functional recovery. Erector spinae plane block (ESPB) is a newly described interfascial plane block. ESPB is effective on both visceral and somatic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block group | Experimental | Other: Erector Spinae Plane BlockPatients will receive erector spinae plane block after induction of anesthesia. |
| Control group | No intervention | –Patients will not receive erector spinae plane block. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age from 6 to 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II, III.
- Patients with spastic cerebral palsy undergoing selective dorsal rhizotomy.
Key exclusion criteria (5 listed)
- Allergy to local anesthetics.
- Severe fixed joint deformity.
- Previous orthopedic surgery.
- Patient with abnormal liver/kidney function.
- Patient with skin damage or infection at the proposed puncture site.
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 BlockPatients will receive erector spinae plane block after induction of anesthesia. | Other | Erector Spinae Plane Block group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia of 0.05 mg/kg morphine will be given if the Wong-Baker score is 4 more to be repeated after 30 min if pain persists until the Wong-Baker score < 4.
4 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Patient satisfaction
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 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 21 Nov 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Erector Spinae Plane Block in people with Erector Spinae Plane Block and Opioid, run by Tanta 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 4 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 Nov 2025. 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?
Total morphine consumption (time frame: 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 21 Nov 2025.