Pain, PostoperativePhase 2/3ITVSEpiduralNCT02988700
Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery
A Phase 2/3 study testing Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5% and caudal plain bupivacaine 2.5mg/kg 0.25% in people with Pain, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5% and caudal plain bupivacaine 2.5mg/kg 0.25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Nov 2018
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2-12 years.
- Weight: 15-40 kg.
- Sex: both males and females.
- ASA physical status: 1-II.
- Operation: surgery below umbilicus.
Who cannot join
- Allergic reaction to local anesthetics (LAs).
- Local or systemic infection (risk of meningitis).
- Coagulopathy.
- Intracranial hypertension.
- Hydrocephalus.
- Intracranial hemorrhage.
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- Parental refusal.
- Hypovolemia.
- Spinal deformities, such as spina bifida or myelomeningocele.
- Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery
Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.
Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.
- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.
Read the detailed description
The historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia.
-Pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (paracetamol).
Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.
Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.
- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.
- Conditions
- Pain, Postoperative
- Being tested
- Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%, caudal plain bupivacaine 2.5mg/kg 0.25%
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%Drug
Also called Marcain
The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.
caudal plain bupivacaine 2.5mg/kg 0.25%Drug
Also called Bucain
The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.
| Study group | Role | What they receive |
|---|---|---|
| Spinal group | Active comparator | Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.
be given by . Receives: Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5% |
| Caudal group | Active comparator | caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper. Receives: Drug: caudal plain bupivacaine 2.5mg/kg 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC Score
FLACC scores will be recorded.
Measured: 24 hours
Secondary outcomes (4)
Total consumption of rescue analgesics
The total consumption of postoperative rescue analgesics will be recorded.
Measured: 24 hours
Postoperative Agitation
Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.
Measured: 60 min.
Adverse effects
Any adverse effect will be treated and recorded.
Measured: 24 hours
Residual motor paralysis
By the Modified Bromage scale
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988700
- Sponsor's protocol ID
- IRB00008718/36800
- Acronym
- ITVSEpidural
- Status last verified
- Jan 2021
- First submitted
- 25 Nov 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery
- ClinicalTrials.gov ID
- NCT02988700
- Acronym / sponsor ID
- ITVSEpidural / IRB00008718/36800
- Conditions
- Pain, Postoperative
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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.
Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.
Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.
- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.
Detailed description
The historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia.
-Pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (paracetamol).
Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.
Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.
- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal group | Active comparator | Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad. be given by . |
| Caudal group | Active comparator | Drug: caudal plain bupivacaine 2.5mg/kg 0.25%caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 2-12 years.
- Weight: 15-40 kg.
- Sex: both males and females.
- ASA physical status: 1-II.
- Operation: surgery below umbilicus.
Key exclusion criteria (10 listed)
- Allergic reaction to local anesthetics (LAs).
- Local or systemic infection (risk of meningitis).
- Coagulopathy.
- Intracranial hypertension.
- Hydrocephalus.
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 |
|---|---|---|
| Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%Also: MarcainThe lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad. | Drug | Spinal group |
| caudal plain bupivacaine 2.5mg/kg 0.25%Also: BucainThe sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper. | Drug | Caudal group |
Primary outcome
FLACC Score
Time frame: 24 hours
FLACC scores will be recorded.
4 secondary outcomes
Total consumption of rescue analgesics
Time frame: 24 hours
Postoperative Agitation
Time frame: 60 min.
Adverse effects
Time frame: 24 hours
Residual motor paralysis
Time frame: 6 hours
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 13 Jan 2021.
- 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.
Hala S Abdel-Ghaffar, MD principal investigator
Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
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 Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5% and caudal plain bupivacaine 2.5mg/kg 0.25% in people with Pain, Postoperative, run by Assiut 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 5 inclusion and 10 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 13 Jan 2021. 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?
FLACC Score (time frame: 24 hours). 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 13 Jan 2021.