UltrasoundNCT06862518
Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Erector Spinae Plane Block for Post Operative Analgesia in Pediatrics Undergoing Thoracotomy
A study testing Serratus Anterior Plane Block (SAPB) group and Erector Spinae Plane Block (ESPB) group in people with Ultrasound and Serratus Anterior Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study is designed to compare the post operative analgesic effect of serratus anterior plane block versus thoracic erector spinae plane block in pediatrics undergoing thoracotomy Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Ultrasound, Serratus Anterior Plane Block, Thoracic Erector Spinae Plane Block
- What is being tested?
- Serratus Anterior Plane Block (SAPB) group and Erector Spinae Plane Block (ESPB) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient aged between 2 and 7 years.
- Patient posted for the right or left thoracotomy under general anesthesia.
Who cannot join
- Parents who refuse regional anesthesia.
- Children who had any coagulation abnormality.
- Deformity of the thoracolumbar spine.
- Infection at the site of injection.
- History of allergy to the local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Erector Spinae Plane Block for Post Operative Analgesia in Pediatrics Undergoing Thoracotomy: A Randomized Controlled Stud
This study is designed to compare the post operative analgesic effect of serratus anterior plane block versus thoracic erector spinae plane block in pediatrics undergoing thoracotomy
Read the detailed description
The incidence of diseases that requires thoracotomy is low in the pediatric age group. Thoracotomy is a severe burden on children and is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause retention of secretion, atelectasis, ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics.
The serratus anterior plane block (SAPB) has also recently become more popular options for post-thoracotomy analgesia. SAPB involves local anesthetic injection in a plane superficial or deep to the serratus anterior muscle; in both these locations, it blocks the lateral cutaneous branches of intercostal nerves.
The erector spinae plane block (ESPB) is an ultrasound-guided deep plane interfascial block defined by Forero in 2016. It has been shown to provide thoracic and abdominal analgesia. When injected at the T5 transverse process level, the local anesthetic spreads anteriorly through the thoracolumbar fascia and reaches the ventral and dorsal rami of the spinal nerves and posteriorly to the gray and white rami communicantes of the sympathetic chain, providing a C7 to T8 sensitive block. Although it was first described as a chronic pain block, there are increasingly reports about its use in postoperative acute pain.
- Conditions
- Ultrasound, Serratus Anterior Plane Block, Thoracic Erector Spinae Plane Block, Post Operative Analgesia, Pediatrics, Thoracotomy
- Being tested
- Control group, Serratus Anterior Plane Block (SAPB) group, Erector Spinae Plane Block (ESPB) group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDrug
Also called General anesthesia
Patients will receive general anesthesia alone
Serratus Anterior Plane Block (SAPB) groupDrug
Also called General anesthesia (GA) with bupivacaine
Patients will receive general anesthesia (GA) with ultrasound guided serratus anterior plane block 0.5 ml/kg 0.25% bupivacaine.
Erector Spinae Plane Block (ESPB) groupDrug
Also called General anesthesia (GA) with bupivacaine
Patients will receive general anesthesia (GA) with ultrasound guided erector spinae plane block 0.5 ml/kg 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will receive general anesthesia alone Receives: Drug: Control group |
| Serratus Anterior Plane Block (SAPB) group | Experimental | Patients will receive general anesthesia (GA) with ultrasound guided serratus anterior plane block 0.5 ml/kg 0.25% bupivacaine. Receives: Drug: Serratus Anterior Plane Block (SAPB) group |
| Erector Spinae Plane Block (ESPB) group | Experimental | Patients will receive general anesthesia (GA) with ultrasound guided erector spinae plane block 0.5 ml/kg 0.25% bupivacaine. Receives: Drug: Erector Spinae Plane Block (ESPB) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total rescue analgesia consumption
Rescue analgesia is planned based on the patients' face, leg, activity, cry, consolability score (FLACC) scores. Morphine 0.05 mg/kg IV was given as rescue analgesia in the case of FLACC scores above 3.The analgesic requirements in the first 24 h postoperatively were recorded.
Measured: 24 hours postoperatively
Secondary outcomes (2)
Time to 1st rescue analgesic requirement
Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated) was recorded.
Measured: 24 hours postoperatively
Degree of pain
Pain was assessed after surgery over 24 hours using face, leg, activity, cry, consolability score (FLACC) score at following times: 0 (baseline), 1, 3, 6, 8, 12, and 24 h postoperative. FLACC score is used for pain assessment. (Face, legs, activity, cry and Consolability) is a measurement used to assess pain in children between age of 2 to 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0 to 10 with 0 representing no pain, 10 representing the maximum and we start to give rescue analgesia at score 4.
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 posted6 Mar 2025
- Study start1 Jul 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies 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
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Elsayed Mohamed Mohamed Hassan, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862518
- Sponsor's protocol ID
- 36264MS209/6/23
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 6 Mar 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Erector Spinae Plane Block for Post Operative Analgesia in Pediatrics Undergoing Thoracotomy: A Randomized Controlled Stud
- ClinicalTrials.gov ID
- NCT06862518
- Acronym / sponsor ID
- 36264MS209/6/23
- Conditions
- Ultrasound, Serratus Anterior Plane Block, Thoracic Erector Spinae Plane Block, Post Operative Analgesia, Pediatrics, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 6 Mar 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.
This study is designed to compare the post operative analgesic effect of serratus anterior plane block versus thoracic erector spinae plane block in pediatrics undergoing thoracotomy
Detailed description
The incidence of diseases that requires thoracotomy is low in the pediatric age group. Thoracotomy is a severe burden on children and is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause retention of secretion, atelectasis, ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics.
The serratus anterior plane block (SAPB) has also recently become more popular options for post-thoracotomy analgesia. SAPB involves local anesthetic injection in a plane superficial or deep to the serratus anterior muscle; in both these locations, it blocks the lateral cutaneous branches of intercostal nerves.
The erector spinae plane block (ESPB) is an ultrasound-guided deep plane interfascial block defined by Forero in 2016. It has been shown to provide thoracic and abdominal analgesia. When injected at the T5 transverse process level, the local anesthetic spreads anteriorly through the thoracolumbar fascia and reaches the ventral and dorsal rami of the spinal nerves and posteriorly to the gray and white rami communicantes of the sympathetic chain, providing a C7 to T8 sensitive block. Although it was first described as a chronic pain block, there are increasingly reports about its use in postoperative acute pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Control groupPatients will receive general anesthesia alone |
| Serratus Anterior Plane Block (SAPB) group | Experimental | Drug: Serratus Anterior Plane Block (SAPB) groupPatients will receive general anesthesia (GA) with ultrasound guided serratus anterior plane block 0.5 ml/kg 0.25% bupivacaine. |
| Erector Spinae Plane Block (ESPB) group | Experimental | Drug: Erector Spinae Plane Block (ESPB) groupPatients will receive general anesthesia (GA) with ultrasound guided erector spinae plane block 0.5 ml/kg 0.25% bupivacaine. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient aged between 2 and 7 years.
- Patient posted for the right or left thoracotomy under general anesthesia.
Key exclusion criteria (5 listed)
- Parents who refuse regional anesthesia.
- Children who had any coagulation abnormality.
- Deformity of the thoracolumbar spine.
- Infection at the site of injection.
- History of allergy to the local anesthetics.
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 |
|---|---|---|
| Control groupAlso: General anesthesiaPatients will receive general anesthesia alone | Drug | Control group |
| Serratus Anterior Plane Block (SAPB) groupAlso: General anesthesia (GA) with bupivacainePatients will receive general anesthesia (GA) with ultrasound guided serratus anterior plane block 0.5 ml/kg 0.25% bupivacaine. | Drug | Serratus Anterior Plane Block (SAPB) group |
| Erector Spinae Plane Block (ESPB) groupAlso: General anesthesia (GA) with bupivacainePatients will receive general anesthesia (GA) with ultrasound guided erector spinae plane block 0.5 ml/kg 0.25% bupivacaine | Drug | Erector Spinae Plane Block (ESPB) group |
Primary outcome
Total rescue analgesia consumption
Time frame: 24 hours postoperatively
Rescue analgesia is planned based on the patients' face, leg, activity, cry, consolability score (FLACC) scores. Morphine 0.05 mg/kg IV was given as rescue analgesia in the case of FLACC scores above 3.The analgesic requirements in the first 24 h postoperatively were recorded.
2 secondary outcomes
Time to 1st rescue analgesic requirement
Time frame: 24 hours postoperatively
Degree of pain
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 6 Mar 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 Serratus Anterior Plane Block (SAPB) group and Erector Spinae Plane Block (ESPB) group in people with Ultrasound and Serratus Anterior Plane Block, 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 2 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 6 Mar 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 rescue analgesia 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 6 Mar 2025.