Surgical PainPhase 2/3NCT06815094
Erector Spinae Plane Block Versus Caudal Epidural Analgesia
A Phase 2/3 study testing Regional analgesia either CEA or ESP in people with Surgical Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the analgesic effect and safety of erector spinae plane block vs caudal epidural block in paediatric population undergoing lower limb cancer surgery. The main questions it aims to answer are: Which of them has a superior analgesic effect. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Surgical Pain
- What is being tested?
- Regional analgesia either CEA or ESP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2022to 14 Feb 2024
- Phase
- Phase 2/3
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA ( American Society of Anaesthesiologists) II (Cancer patient receiving chemotherapy).
- 8 - 15 years of age.
- Planned to undergo unilateral lower limb cancer surgery.
Who cannot join
- Patients with coagulopathy with INR (International Normalization Ratio) > 1.6 (e.g.: haemophilia, fibrinogen abnormalities and deficiency with concentration < 60 %).
- History of allergy to local anaesthetics or any of the additives.
- Patients refused to be included in the study or their guardians.
- CNS (Central Nervous System) pathology.
- Unstable cardiovascular disease.
- Local or systemic infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Erector Spinae Plane Block Versus Caudal Epidural Block in Alleviating Intra- & Post-operative Pain in Pediatric Patients Undergoing Lower Limb Cancer Surgeries
The goal of this clinical trial is to compare the analgesic effect and safety of erector spinae plane block vs caudal epidural block in paediatric population undergoing lower limb cancer surgery. The main questions it aims to answer are:
- Which of them has a superior analgesic effect.
- which of them is more safe and has less complication rate. Participants or their guardians should agree to share in the study (after full explanation of risks and benefits) to receive one of the previously mentioned regional blocks in conjunction with the classic balanced general anaesthesia.
Read the detailed description
This randomized parallel group clinical trial was carried out on 32 paediatric patients aged from 8 to 15 years old, both sexes, belonging to American Society of Anaesthesiologists II physical status, cancer patient receiving chemotherapy undergoing unilateral lower limb cancer surgery. Patients were divided into two equal groups: Group A: patients received selective unilateral ESPB and group B: patients received CEB. Both in conjunction with general anaesthesia. The primary outcomes were determining the postoperative time of first rescue analgesia and assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery. The secondary outcomes were assessments of the pain severity intra- and post-operative parallel with recording any complication regarding drugs or procedures.
- Conditions
- Surgical Pain
- Being tested
- Regional analgesia either CEA or ESP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional analgesia either CEA or ESPProcedure or surgery
Ultrasound guided local anesthetic injection in the course of the conducting nerve to decrease pain transmission.
| Study group | Role | What they receive |
|---|---|---|
| Group of patients received Caudal Epidural Analgesia | Active comparator | Pediatric patients aged 8 to 15 years of age undergoing unilateral lower limb cancer surgery are recruited from National Cancer Institute \& randomly allocated to this group. Receives: Procedure: Regional analgesia either CEA or ESP |
| Group of patients received Erector Spinae Plane block | Active comparator | Pediatric patients aged 8 to 15 years of age undergoing unilateral lower limb cancer surgery are recruited from National Cancer Institute \& randomly allocated to this group. Receives: Procedure: Regional analgesia either CEA or ESP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the actual postoperative time of need for the first rescue analgesia
Compare the actual postoperative time of need for the first rescue analgesia by the Numerical Rating Score in all cases in both groups when it is equal to or more than 4.
Measured: Immediately and up to the first 12 hours post-operatively.
Assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery.
Calculation of total postoperative morphine consumption in both groups.
Measured: Immediately and up to the first 12 hours post-operatively.
Secondary outcomes (2)
Assessments of the pain severity intra- and post-operatively.
Using Numerical Rating Score for postoperative pain assessment and vital data with fentanyl consumption for intraoperative pain assessment.
Measured: Intraoperatively and up to 12 hours postoperatively.
Recording any complication regarding drugs or procedures.
for example hypotension or local anaesthetic toxicity.
Measured: Intraoperatively and up to 12 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start28 Nov 2022
- Primary completion14 Nov 2023
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical PainStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel group clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atef Badran, MD, Study director, National cancer institute - Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815094
- Sponsor's protocol ID
- AP2211-301-044
- Status last verified
- Nov 2022
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Erector Spinae Plane Block Versus Caudal Epidural Block in Alleviating Intra- & Post-operative Pain in Pediatric Patients Undergoing Lower Limb Cancer Surgeries
- ClinicalTrials.gov ID
- NCT06815094
- Acronym / sponsor ID
- AP2211-301-044
- Conditions
- Surgical Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 7 Feb 2025 (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 goal of this clinical trial is to compare the analgesic effect and safety of erector spinae plane block vs caudal epidural block in paediatric population undergoing lower limb cancer surgery. The main questions it aims to answer are:
- Which of them has a superior analgesic effect.
- which of them is more safe and has less complication rate. Participants or their guardians should agree to share in the study (after full explanation of risks and benefits) to receive one of the previously mentioned regional blocks in conjunction with the classic balanced general anaesthesia.
Detailed description
This randomized parallel group clinical trial was carried out on 32 paediatric patients aged from 8 to 15 years old, both sexes, belonging to American Society of Anaesthesiologists II physical status, cancer patient receiving chemotherapy undergoing unilateral lower limb cancer surgery. Patients were divided into two equal groups: Group A: patients received selective unilateral ESPB and group B: patients received CEB. Both in conjunction with general anaesthesia. The primary outcomes were determining the postoperative time of first rescue analgesia and assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery. The secondary outcomes were assessments of the pain severity intra- and post-operative parallel with recording any complication regarding drugs or procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized parallel group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group of patients received Caudal Epidural Analgesia | Active comparator | Procedure: Regional analgesia either CEA or ESPPediatric patients aged 8 to 15 years of age undergoing unilateral lower limb cancer surgery are recruited from National Cancer Institute \& randomly allocated to this group. |
| Group of patients received Erector Spinae Plane block | Active comparator | Procedure: Regional analgesia either CEA or ESPPediatric patients aged 8 to 15 years of age undergoing unilateral lower limb cancer surgery are recruited from National Cancer Institute \& randomly allocated to this group. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA ( American Society of Anaesthesiologists) II (Cancer patient receiving chemotherapy).
- 8 - 15 years of age.
- Planned to undergo unilateral lower limb cancer surgery.
Key exclusion criteria (6 listed)
- Patients with coagulopathy with INR (International Normalization Ratio) > 1.6 (e.g.: haemophilia, fibrinogen abnormalities and deficiency with concentration < 60 %).
- History of allergy to local anaesthetics or any of the additives.
- Patients refused to be included in the study or their guardians.
- CNS (Central Nervous System) pathology.
- Unstable cardiovascular disease.
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 |
|---|---|---|
| Regional analgesia either CEA or ESPUltrasound guided local anesthetic injection in the course of the conducting nerve to decrease pain transmission. | Procedure or surgery | Group of patients received Caudal Epidural Analgesia, Group of patients received Erector Spinae Plane block |
Primary outcome
Determining the actual postoperative time of need for the first rescue analgesia
Time frame: Immediately and up to the first 12 hours post-operatively.
Compare the actual postoperative time of need for the first rescue analgesia by the Numerical Rating Score in all cases in both groups when it is equal to or more than 4.
Assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery.
Time frame: Immediately and up to the first 12 hours post-operatively.
Calculation of total postoperative morphine consumption in both groups.
2 secondary outcomes
Assessments of the pain severity intra- and post-operatively.
Time frame: Intraoperatively and up to 12 hours postoperatively.
Recording any complication regarding drugs or procedures.
Time frame: Intraoperatively and up to 12 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 7 Feb 2025.
- 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.
Atef Badran, MD study director
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 Phase 2/3 study testing Regional analgesia either CEA or ESP in people with Surgical Pain, 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 6 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 7 Feb 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Determining the actual postoperative time of need for the first rescue analgesia (time frame: Immediately and up to the first 12 hours post-operatively.). The study lists 2 primary outcomes in all. 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 7 Feb 2025.