AnesthesiaNCT06871995
Efficacy, Safety and Limitations of Spinal Block for All Infants Under 3 Months
A study testing spinal block in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Spinal anesthesia (SA) has been shown to be a viable alternative to general anesthesia (GA) for infants and children for a variety of surgical procedures. SA serves to avoid some of the potential risks of GA including the need for airway manipulation, hemodynamic instability, postoperative apnea, and exposure to… Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Anesthesia
- What is being tested?
- spinal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to Mar 2026
- 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 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age under 3 months.
- Physical status: American Society of Anesthesiologists I - II.
- Elective lower abdominal surgeries such as: hernia, hydrocele, undescended testis
Who cannot join
- Patient's parents or legal guardian refusing to do this specific procedure.
- Coagulopathy, use of anti-coagulant or antiplatelet therapy.
- Infection at the site of injection.
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
Faculty of Medicine Ain Shams University
Cairo
About this study
Official title: Efficacy, Safety and Limitations of Spinal Block When Used for All Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery
Spinal anesthesia (SA) has been shown to be a viable alternative to general anesthesia (GA) for infants and children for a variety of surgical procedures. SA serves to avoid some of the potential risks of GA including the need for airway manipulation, hemodynamic instability, postoperative apnea, and exposure to medications that may cause neurotoxicity .SA allows the prevention and reduction of perioperative complications even if its duration is an important limiting factor. Because of this limitation, short surgery is the most indicated under SA . Premature infants and neurologically impaired children account for the majority of spinal anesthetics used today .
This study evaluates the effectiveness, safety and limitations of spinal anesthesia when used for all infants under 3 months undergoing lower abdominal surgery at Ain Shams University Hospitals.
Read the detailed description
Patients will be carefully examined 24 hours (h) to the procedure and every case will be assessed individually concerning its eligibility for spinal anesthesia under the supervision of a senior pediatric anesthesiologist. History taking and clinical examination along with the necessary laboratory tests . Standard blood test is cbc and we will use it a routine before surgery. About 1 ml blood is needed as a sample.
Counseling the parents or the legal guardian regarding every aspect of the procedure and obtaining their informed written consent.
All patients will be fasting from formula milk for 6 hours, breast milk for 4 hours and clear fluid for 1 h before anesthesia . No overnight premedication will be given.
After the establishment of intravenous access, all patients will be given crystalloid solution (Ringer's solution or Normal Saline) of 10 ml/kg over 30 minutes started with the application of monitors. Heart rate, blood pressure, oxygen saturation. Blood glucose level is measured.
The monitors will be connected and pulse oximetry (SPO2) baseline non-invasive blood pressure (NIBP), heart rate (HR), and electrocardiogram (ECG tracings) will be obtained. Fluid bolus of 5 ml/kg will be used for any intraoperative hypotension. Atropine 50µ/kg will be given intravenously if HR dropped > 20% of baseline reading . Intraoperative blood loss will be replaced by 3 times volume with the same crystalloid .blood glucose level is measured after injection then every 30 minutes till end of surgery .
All patients will receive spinal anesthesia via midline approach with patients in sitting position established by assistant under complete aseptic conditions. A subcutaneous bleb using Lidocaine 1% through the needle of an insulin syringe followed by minor skin scratch to will help avoiding possible intrathecal dermoid implantation . A lumbar puncture will be performed in L4-L5 or L5- S1 interspace using 25-G 25-mm pencil-point spinal needle . Depth of epidural space is anticipated at 0.1 mm/kg . After getting free flow of cerebrospinal fluid (CSF) hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg (0.1 ml/kg) will be slowly injected in the subarachnoid space . The end of the injection will be taken as time zero for further data recording.
Since the Bromage score is not assessable among this pediatric population, the success of the spinal anesthesia is estimated and based on the presence of profound motor block (unable to move feet, knees and legs) in the lower extremities and the absence of a skin prick response using toothed forceps at the appropriate dermatome level. If these signs will not confirmed after 5 min, general anesthesia will be performed . All of these cases will be registered as spinal block failure Then pacifier dipped with sugar water will be offered to the baby.
Throughout the operation, the effect of the spinal anesthesia will be monitored till return of spontaneous movement or response to surgical stimulus then sevoflurane mask will be applied and surgery continues either mask or even intubation then mean time of conversion to general anesthesia will be recorded and registered as spinal block failure.
Complications from SA:
Hypotension is defined as a more than 20%decrease in mean blood pressure from baseline. (Mean blood pressure =post conceptual age in weeks ).
Bradycardia is defined as a heart rate less than 120 b/min or HR dropped > 20% of baseline reading) Apnea is defined as a sustained respiratory pause of 15 s or longer or less than15s if accompanied by oxygen saturation (SpO2) less than 90% or bradycardia. Hypoxemia is defined as oxygen saturation below 90% .
High spinal block is defined as apnea after spinal injection without sedative drugs and/or motor block of the upper extremities and no response to hand finger pinprick All this complications will be monitored intra and postoperatively and managed accordingly.
All patients will be admitted postoperative for 12 hours in the hospital. Post operative cbc also a routine blood test will be done .The conductors of this study will record the degree of motor block and pain. The pain control will be measured using the Face, Legs, Activity, Crying, and Controllability (FLACC) pain score (0-10 score range) . The FLACC score will be evaluated and recorded during the first 12h immediately postoperative and at 2, 4, 6, 12 hours postoperatively. The time of giving analgesia (intravenous paracetamol 15 mg/kg) will be recorded when the FLACC score exceeds 4, with a maximum of four doses per day, and total paracetamol consumption will be recorded . It is given that pain medications will be given when the FLACC score exceeds 4 at assessment or in between of the allotted time interval.
- Conditions
- Anesthesia
- Being tested
- spinal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal blockProcedure or surgery
All patients will receive spinal anesthesia via midline approach with patients in sitting position established by assistant under complete aseptic conditions. A subcutaneous bleb using Lidocaine 1% through the needle of an insulin syringe followed by minor skin scratch to will help avoiding possible intrathecal dermoid implantation . A lumbar puncture will be performed in L4-L5 or L5- S1 interspace using 25-G 25-mm pencil-point spinal needle . Depth of epidural space is anticipated at 0.1 mm/kg . After getting free flow of cerebrospinal fluid (CSF) hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg (0.1 ml/kg) will be slowly injected in the subarachnoid space . The end of the injection will be taken as time zero for further data recording.
| Study group | Role | What they receive |
|---|---|---|
| one arm All Infants Under 3 Months of Age receiving Spinal Block | Experimental | All Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery Receives: Procedure: spinal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of spinal block in abdominal surgeries in infants under 3 months of age.
Success rate = (no of total patients - no of all converted general anesthesia patients) divided by no of total cases%.
Measured: during the surgery
Secondary outcomes (5)
Duration of spinal block in minutes
Duration of spinal block
Measured: during the surgery
Number of attempts
Number of attempts till success
Measured: during the surgery
Depth of insertion of the spinal needle
from skin to subarachnoid space
Measured: during the surgery
Blood glucose level
sample to measure blood glucose
Measured: every 30 minutes till end of surgery
Determine the incidence of complications
- Apnea that will be considered as high spinal block
- Hypotension (a more than 20% decrease in systolic blood pressure from baseline.)
- Bradycardia (a heart rate less than120 /min or HR dropped > 20% of baseline reading)
- Hypoxemia (oxygen saturation below 90%) .
Measured: after spinal block to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Not applicable
- Intervention model
- Single group
- Model description
- spinal block in infants less than 3 months of age undergoing lower abdominal surgery
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hany mo Elzahaby, prof, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871995
- Sponsor's protocol ID
- FMASU MD234/2024
- Status last verified
- Jan 2025
- First submitted
- 21 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Limitations of Spinal Block When Used for All Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06871995
- Acronym / sponsor ID
- FMASU MD234/2024
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 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.
Spinal anesthesia (SA) has been shown to be a viable alternative to general anesthesia (GA) for infants and children for a variety of surgical procedures. SA serves to avoid some of the potential risks of GA including the need for airway manipulation, hemodynamic instability, postoperative apnea, and exposure to medications that may cause neurotoxicity .SA allows the prevention and reduction of perioperative complications even if its duration is an important limiting factor. Because of this limitation, short surgery is the most indicated under SA . Premature infants and neurologically impaired children account for the majority of spinal anesthetics used today .
This study evaluates the effectiveness, safety and limitations of spinal anesthesia when used for all infants under 3 months undergoing lower abdominal surgery at Ain Shams University Hospitals.
Detailed description
Patients will be carefully examined 24 hours (h) to the procedure and every case will be assessed individually concerning its eligibility for spinal anesthesia under the supervision of a senior pediatric anesthesiologist. History taking and clinical examination along with the necessary laboratory tests . Standard blood test is cbc and we will use it a routine before surgery. About 1 ml blood is needed as a sample.
Counseling the parents or the legal guardian regarding every aspect of the procedure and obtaining their informed written consent.
All patients will be fasting from formula milk for 6 hours, breast milk for 4 hours and clear fluid for 1 h before anesthesia . No overnight premedication will be given.
After the establishment of intravenous access, all patients will be given crystalloid solution (Ringer's solution or Normal Saline) of 10 ml/kg over 30 minutes started with the application of monitors. Heart rate, blood pressure, oxygen saturation. Blood glucose level is measured.
The monitors will be connected and pulse oximetry (SPO2) baseline non-invasive blood pressure (NIBP), heart rate (HR), and electrocardiogram (ECG tracings) will be obtained. Fluid bolus of 5 ml/kg will be used for any intraoperative hypotension. Atropine 50µ/kg will be given intravenously if HR dropped > 20% of baseline reading . Intraoperative blood loss will be replaced by 3 times volume with the same crystalloid .blood glucose level is measured after injection then every 30 minutes till end of surgery .
All patients will receive spinal anesthesia via midline approach with patients in sitting position established by assistant under complete aseptic conditions. A subcutaneous bleb using Lidocaine 1% through the needle of an insulin syringe followed by minor skin scratch to will help avoiding possible intrathecal dermoid implantation . A lumbar puncture will be performed in L4-L5 or L5- S1 interspace using 25-G 25-mm pencil-point spinal needle . Depth of epidural space is anticipated at 0.1 mm/kg . After getting free flow of cerebrospinal fluid (CSF) hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg (0.1 ml/kg) will be slowly injected in the subarachnoid space . The end of the injection will be taken as time zero for further data recording.
Since the Bromage score is not assessable among this pediatric population, the success of the spinal anesthesia is estimated and based on the presence of profound motor block (unable to move feet, knees and legs) in the lower extremities and the absence of a skin prick response using toothed forceps at the appropriate dermatome level. If these signs will not confirmed after 5 min, general anesthesia will be performed . All of these cases will be registered as spinal block failure Then pacifier dipped with sugar water will be offered to the baby.
Throughout the operation, the effect of the spinal anesthesia will be monitored till return of spontaneous movement or response to surgical stimulus then sevoflurane mask will be applied and surgery continues either mask or even intubation then mean time of conversion to general anesthesia will be recorded and registered as spinal block failure.
Complications from SA:
Hypotension is defined as a more than 20%decrease in mean blood pressure from baseline. (Mean blood pressure =post conceptual age in weeks ).
Bradycardia is defined as a heart rate less than 120 b/min or HR dropped > 20% of baseline reading) Apnea is defined as a sustained respiratory pause of 15 s or longer or less than15s if accompanied by oxygen saturation (SpO2) less than 90% or bradycardia. Hypoxemia is defined as oxygen saturation below 90% .
High spinal block is defined as apnea after spinal injection without sedative drugs and/or motor block of the upper extremities and no response to hand finger pinprick All this complications will be monitored intra and postoperatively and managed accordingly.
All patients will be admitted postoperative for 12 hours in the hospital. Post operative cbc also a routine blood test will be done .The conductors of this study will record the degree of motor block and pain. The pain control will be measured using the Face, Legs, Activity, Crying, and Controllability (FLACC) pain score (0-10 score range) . The FLACC score will be evaluated and recorded during the first 12h immediately postoperative and at 2, 4, 6, 12 hours postoperatively. The time of giving analgesia (intravenous paracetamol 15 mg/kg) will be recorded when the FLACC score exceeds 4, with a maximum of four doses per day, and total paracetamol consumption will be recorded . It is given that pain medications will be given when the FLACC score exceeds 4 at assessment or in between of the allotted time interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- spinal block in infants less than 3 months of age undergoing lower abdominal surgery
| Arm | Type | Receives |
|---|---|---|
| one arm All Infants Under 3 Months of Age receiving Spinal Block | Experimental | Procedure: spinal blockAll Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age under 3 months.
- Physical status: American Society of Anesthesiologists I - II.
- Elective lower abdominal surgeries such as: hernia, hydrocele, undescended testis
Key exclusion criteria (3 listed)
- Patient's parents or legal guardian refusing to do this specific procedure.
- Coagulopathy, use of anti-coagulant or antiplatelet therapy.
- Infection at the site of injection.
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 |
|---|---|---|
| spinal blockAll patients will receive spinal anesthesia via midline approach with patients in sitting position established by assistant under complete aseptic conditions. A subcutaneous bleb using Lidocaine 1% through the needle of an insulin syringe followed by minor skin scratch to will help avoiding possible intrathecal dermoid implantation . A lumbar puncture will be performed in L4-L5 or L5- S1 interspace using 25-G 25-mm pencil-point spinal needle . Depth of epidural space is anticipated at 0.1 mm/kg . After getting free flow of cerebrospinal fluid (CSF) hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg (0.1 ml/kg) will be slowly injected in the subarachnoid space . The end of the injection will be taken as time zero for further data recording. | Procedure or surgery | one arm All Infants Under 3 Months of Age receiving Spinal Block |
Primary outcome
the success rate of spinal block in abdominal surgeries in infants under 3 months of age.
Time frame: during the surgery
Success rate = (no of total patients - no of all converted general anesthesia patients) divided by no of total cases%.
5 secondary outcomes
Duration of spinal block in minutes
Time frame: during the surgery
Number of attempts
Time frame: during the surgery
Depth of insertion of the spinal needle
Time frame: during the surgery
Blood glucose level
Time frame: every 30 minutes till end of surgery
Determine the incidence of complications
Time frame: after spinal block to end of surgery
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 12 Mar 2025.
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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.
hany mo Elzahaby, prof study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal block in people with Anesthesia, run by Ain Shams 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 3 inclusion and 3 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 12 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?
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 ahmed ma Elewa mohamed, M.S.C (+201028143995, AhmedElfax@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the success rate of spinal block in abdominal surgeries in infants under 3 months of age. (time frame: during the surgery). 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 12 Mar 2025.