Inguinal HerniaRCTNCT05969613
Comparison of Regional Block, Wound Infiltration and Caudal Block for Pain Management in Children
A study testing Regional block, Wound infiltration and Caudal block in people with Inguinal Hernia, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Comparison of regional block, wound infiltration and caudal block for post operative pain management in participants undergoing inguinal herniotomy. Read more about this study
- Who is it for?
- Ages 2 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Regional block, Wound infiltration and Caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2019to 1 Jun 2020
- 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 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- •Patients under 13 years of age
- •Inguinal hernia
Who cannot join
- •History of allergy to any drugs used in study documented on history.
- •Infection at the site of regional, caudal or local infiltration, documented on clinical examination.
- •Irreducible, obstructed or strangulated hernia, documented on clinical examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Regional Block, Wound Infiltration and Caudal Block for Post Operative Pain Management in Children Undergoing Inguinal Herniotomy
Comparison of regional block, wound infiltration and caudal block for post operative pain management in participants undergoing inguinal herniotomy.
Read the detailed description
Investigators are comparing three modalities (regional block, wound infiltration and caudal block), for post operative pain management in participants after inguinal herniotomy.
- Conditions
- Inguinal Hernia
- Being tested
- Regional block, Wound infiltration, Caudal block
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional blockProcedure or surgery
regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline
Wound infiltrationProcedure or surgery
Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose
Caudal blockProcedure or surgery
Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose
| Study group | Role | What they receive |
|---|---|---|
| Regional Block | Experimental | Bupivacaine 0.25% Receives: Procedure: Regional block |
| Wound infilteration | Active comparator | Bupivacaine 0.25% Receives: Procedure: Wound infiltration |
| caudal block | Active comparator | Bupivacaine 0.25% Receives: Procedure: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain -FLACC Pain sacle
Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10.
Measured: Within 24 hours
post operative pain -Wong-Baker Faces pain scale
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Apr 2019
- Primary completion1 Oct 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Numeri, King Edward Medical University
- Investigators
- Mamoonullah Asmati, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969613
- Sponsor's protocol ID
- Fnaumeri
- Acronym
- RCT
- Status last verified
- Jul 2023
- First submitted
- 22 Sep 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Regional Block, Wound Infiltration and Caudal Block for Post Operative Pain Management in Children Undergoing Inguinal Herniotomy
- ClinicalTrials.gov ID
- NCT05969613
- Acronym / sponsor ID
- RCT / Fnaumeri
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 1 Aug 2023 (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.
Comparison of regional block, wound infiltration and caudal block for post operative pain management in participants undergoing inguinal herniotomy.
Detailed description
Investigators are comparing three modalities (regional block, wound infiltration and caudal block), for post operative pain management in participants after inguinal herniotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regional Block | Experimental | Procedure: Regional blockBupivacaine 0.25% |
| Wound infilteration | Active comparator | Procedure: Wound infiltrationBupivacaine 0.25% |
| caudal block | Active comparator | Procedure: Caudal blockBupivacaine 0.25% |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- •Patients under 13 years of age
- •Inguinal hernia
Key exclusion criteria (3 listed)
- •History of allergy to any drugs used in study documented on history.
- •Infection at the site of regional, caudal or local infiltration, documented on clinical examination.
- •Irreducible, obstructed or strangulated hernia, documented on clinical examination.
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 |
|---|---|---|
| Regional blockregional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline | Procedure or surgery | Regional Block |
| Wound infiltrationInfiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose | Procedure or surgery | Wound infilteration |
| Caudal blockInfiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose | Procedure or surgery | caudal block |
Primary outcome
post operative pain -FLACC Pain sacle
Time frame: Within 24 hours
Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10.
post operative pain -Wong-Baker Faces pain scale
Time frame: Within 24 hours
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
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 1 Aug 2023.
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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.
Mamoonullah Asmati principal investigator
King Edward Medical 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 Regional block, Wound infiltration and Caudal block in people with Inguinal Hernia, run by King Edward Medical University at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 1 Aug 2023. 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 Pakistan. 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?
post operative pain -FLACC Pain sacle (time frame: Within 24 hours). The study lists 2 primary outcomes in all. 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 1 Aug 2023.