Erector Spinae Plane BlockNCT06984874
Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy
A study testing Erector spinae plane block and General anesthesia in people with Erector Spinae Plane Block and Children, run by Menoufia University at 1 site in Egypt.
Trial summary
This study aims to evaluate the influence of ultrasound-guided erector spinae plane block on postoperative pain and diaphragmatic dysfunction in pediatric patients undergoing thoracoscopic sympathectomy. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Erector Spinae Plane Block, Children, Thoracoscopic Sympathectomy
- What is being tested?
- Erector spinae plane block and General anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 6 to 16 years.
- Either sexes (male or female).
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for bilateral thoracoscopic sympathectomy under general anesthesia.
Who cannot join
- History of allergy to local anesthetics.
- Abnormal liver/kidney function.
- Severe spinal deformities.
- Bleeding or coagulation disorders.
- Skin damage or infection at the proposed puncture site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University
Shibīn al Kawm, Menoufia, 32511
Safaa M Sallam, Master, 00201001876902, safaa.sallam@med.menofia.edu.eg
Amany S Ammar, MD
About this study
Official title: Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy: A Prospective Controlled Trial
This study aims to evaluate the influence of ultrasound-guided erector spinae plane block on postoperative pain and diaphragmatic dysfunction in pediatric patients undergoing thoracoscopic sympathectomy.
Read the detailed description
Pain may occur after pediatric thoracic surgery in cases such as skin incision creation, rib traction, and drain placement, and in other cases, such as rib nerve injury. Such pain is highly unfavorable to pediatric patients' recovery as it may lead to reduced cough strength for clearing secretions, decreased functional residual capacity, and pulmonary complications such as atelectasis and pneumonia.
Erector spinae plane block (ESPB) is a novel trunk block to relieve chronic neuropathic pain. Since then, it has gained prominence as a regional anesthesia technique with the potential to revolutionize postoperative pain management, and it has been effectively administered not only for the management of perioperative pain for a wide variety of surgeries but also for the management of acute post-traumatic pain and chronic pain.
- Being tested
- Erector spinae plane block, General anesthesia
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 bilateral erector spinae plane block after the induction of general anesthesia as a study group.
General anesthesiaOther
Patients will not receive the block after the induction of general anesthesia as a control group.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group | Experimental | Patients will receive bilateral erector spinae plane block after the induction of general anesthesia as a study group. Receives: Other: Erector spinae plane block |
| Control group | Active comparator | Patients will not receive the block after the induction of general anesthesia as a control group. Receives: Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed on arrival at the post-anesthesia care unit (PACU), 1, 2, 4, 8, 12, and 24 h postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Total analgesic consumption
Total analgesic consumption will be recorded.
Measured: 24 hours postoperatively
Anesthetic consumption: minimum alveolar concentration
Anesthetic consumption: minimum alveolar concentration (MAC) of sevoflurane every 10 min using Anesthetic Consumption = Flow Rate × Concentration of Anesthetic in Vapor.
Measured: Intraoperatively
Diaphragmatic excursion
Diaphragmatic excursion will be recorded using ultrasound preoperatively and postoperatively.
Measured: 24 hours postoperatively
Time to the first request for the rescue analgesia
Time to the first request for the rescue analgesia will be recorded from the end of surgery till first dose of meperidine administrated.
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, and respiratory depression will be recorded.
Measured: 24 hours postoperatively
Recovery profile
Recovery profile will be recorded using Richmond Agitation and Sedation Scale (RASS) was required to be between - 3 and + 4 for a delirium classification (ISMV 4 only; RASS not collected in ISMV 3.
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 posted22 May 2025
- Study start15 Jan 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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 Menoufia 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAFAA MOHAMED SALLAM, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984874
- Sponsor's protocol ID
- 1/2025
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Children Undergoing Thoracoscopic Sympathectomy: A Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT06984874
- Acronym / sponsor ID
- 1/2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 May 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 aims to evaluate the influence of ultrasound-guided erector spinae plane block on postoperative pain and diaphragmatic dysfunction in pediatric patients undergoing thoracoscopic sympathectomy.
Detailed description
Pain may occur after pediatric thoracic surgery in cases such as skin incision creation, rib traction, and drain placement, and in other cases, such as rib nerve injury. Such pain is highly unfavorable to pediatric patients' recovery as it may lead to reduced cough strength for clearing secretions, decreased functional residual capacity, and pulmonary complications such as atelectasis and pneumonia.
Erector spinae plane block (ESPB) is a novel trunk block to relieve chronic neuropathic pain. Since then, it has gained prominence as a regional anesthesia technique with the potential to revolutionize postoperative pain management, and it has been effectively administered not only for the management of perioperative pain for a wide variety of surgeries but also for the management of acute post-traumatic pain and chronic 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 bilateral erector spinae plane block after the induction of general anesthesia as a study group. |
| Control group | Active comparator | Other: General anesthesiaPatients will not receive the block after the induction of general anesthesia as a control group. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 6 to 16 years.
- Either sexes (male or female).
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for bilateral thoracoscopic sympathectomy under general anesthesia.
Key exclusion criteria (5 listed)
- History of allergy to local anesthetics.
- Abnormal liver/kidney function.
- Severe spinal deformities.
- Bleeding or coagulation disorders.
- 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 bilateral erector spinae plane block after the induction of general anesthesia as a study group. | Other | Erector spinae plane block group |
| General anesthesiaPatients will not receive the block after the induction of general anesthesia as a control group. | Other | Control group |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
Postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed on arrival at the post-anesthesia care unit (PACU), 1, 2, 4, 8, 12, and 24 h postoperatively.
6 secondary outcomes
Total analgesic consumption
Time frame: 24 hours postoperatively
Anesthetic consumption: minimum alveolar concentration
Time frame: Intraoperatively
Diaphragmatic excursion
Time frame: 24 hours postoperatively
Time to the first request for the rescue analgesia
Time frame: 24 hours postoperatively
Incidence of complications
Time frame: 24 hours postoperatively
Recovery profile
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
Related trials for Erector Spinae Plane Block
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
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.
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 General anesthesia in people with Erector Spinae Plane Block and Children, run by Menoufia 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: looking for participants now, as of the sponsor's last update on 22 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safaa M Sallam, Master (00201001876902, safaa.sallam@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (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 22 May 2025.