Pain, PostoperativeNCT05117281
Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children
A study testing Levobupivacaine in people with Pain, Postoperative and Analgesia, run by Assiut University at 1 site in Egypt.
Trial summary
Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal anesthesia in infants and children requiring surgeries of the sub-umbilical regions is gaining considerable popularity worldwide. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Pain, Postoperative, Analgesia
- What is being tested?
- Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2021to 15 Oct 2021
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2-10 years.
- Weight: 15-40 kg.
- Sex: both males and females.
- ASA physical status: 1-II.
- Operation: surgery below the umbilicus.
Who cannot join
- Allergic reaction to local anesthetics (LAs).
- Local or systemic infection (risk of meningitis).
- Intracranial hypertension.
- Hydrocephalus.
- Intracranial hemorrhage.
- Coagulopathy.
Show all 10Show fewer
- Hypovolemia.
- Parental refusal.
- 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: Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children: A Randomized Clinical Trial
Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal anesthesia in infants and children requiring surgeries of the sub-umbilical regions is gaining considerable popularity worldwide. 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. Bupivacaine has been thoroughly studied, and a large global experience exists.
Read the detailed description
Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (post-operative apnea). In this population, spinal anesthesia has been proposed as a means to reduce post-operative complications, especially apnea and post-operative respiratory dysfunction, although this utility has been questioned.
Spinal anesthesia modifies the neuroendocrine stress response, ensures a more rapid recovery, and may shorten hospital stay with fewer opioid-induced side effects.
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 an-algesia for approximately 4-6 hours.
- Conditions
- Pain, Postoperative, Analgesia
- Being tested
- Levobupivacaine
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Levobupivacaine hydrate
Plain, isobaric levobupivacaine (0.25%) 1 ml/kg
LevobupivacaineDrug
Also called levobupivacaine hydrate
Plain, isobaric levobupivacaine (0.25%) 0.25 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| spinal group | Active comparator | Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg Receives: Drug: Levobupivacaine |
| caudal group | Active comparator | Plain, isobaric levobupivacaine (0.25%) 1 ml/kg Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded
Face, Legs, Activity, Cry, Consolability scale will be recorded. Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
Measured: 24 hours postoperative
Secondary outcomes (1)
Total consumption of rescue analgesics
mg/24
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start10 Sep 2021
- Primary completion1 Oct 2021
- Study completion15 Oct 2021
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117281
- Sponsor's protocol ID
- 17300727
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 2 Dec 2021
- 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 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05117281
- Acronym / sponsor ID
- 17300727
- Conditions
- Pain, Postoperative, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 11 Nov 2021 (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.
Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal anesthesia in infants and children requiring surgeries of the sub-umbilical regions is gaining considerable popularity worldwide. 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. Bupivacaine has been thoroughly studied, and a large global experience exists.
Detailed description
Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (post-operative apnea). In this population, spinal anesthesia has been proposed as a means to reduce post-operative complications, especially apnea and post-operative respiratory dysfunction, although this utility has been questioned.
Spinal anesthesia modifies the neuroendocrine stress response, ensures a more rapid recovery, and may shorten hospital stay with fewer opioid-induced side effects.
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 an-algesia for approximately 4-6 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal group | Active comparator | Drug: LevobupivacainePlain, isobaric levobupivacaine(0.25%) 0.25 mg/kg |
| caudal group | Active comparator | Drug: LevobupivacainePlain, isobaric levobupivacaine (0.25%) 1 ml/kg |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 2-10 years.
- Weight: 15-40 kg.
- Sex: both males and females.
- ASA physical status: 1-II.
- Operation: surgery below the umbilicus.
Key exclusion criteria (10 listed)
- Allergic reaction to local anesthetics (LAs).
- Local or systemic infection (risk of meningitis).
- Intracranial hypertension.
- Hydrocephalus.
- Intracranial hemorrhage.
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 |
|---|---|---|
| LevobupivacaineAlso: Levobupivacaine hydratePlain, isobaric levobupivacaine (0.25%) 1 ml/kg | Drug | caudal group |
| LevobupivacaineAlso: levobupivacaine hydratePlain, isobaric levobupivacaine (0.25%) 0.25 mg/kg | Drug | spinal group |
Primary outcome
FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded
Time frame: 24 hours postoperative
Face, Legs, Activity, Cry, Consolability scale will be recorded. Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
1 secondary outcome
Total consumption of rescue analgesics
Time frame: 24 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 2 Dec 2021.
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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 Levobupivacaine in people with Pain, Postoperative and Analgesia, 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 2 Dec 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.
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 scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded (time frame: 24 hours postoperative). 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 2 Dec 2021.