Postoperative PainPainseverityNCT06386250
Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy
A study testing regional block, Caudal block and Epidural in people with Postoperative Pain, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- regional block, Caudal block and Epidural
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2019to 6 Jan 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both Male and female inguinal hernia patients
- Patients from 3-12 years age Exclusion Criteria
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Regional Block, Caudal Block and Wound Infiltration for Post-operative Pain Management in Children Undergoing Inguinal Herniotomy
Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.
Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy
Read the detailed description
Three hundred patients rom the department of pediatric surgery, KEMU/Mayo Hospital, were randomized in three study groups by a computer generated table. Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C). . Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age. Patients were discharged after 24 hours. If pain score ≥ 4 was given intravenously, Ketoralac. Urinary retention was observed after 24 hours, wound infection was observed after 7 days.
- Conditions
- Postoperative Pain
- Being tested
- regional block, Caudal block, Epidural
- Keywords
- Postoperative pain, inguinal herniotomy, children, regional block, caudal block, wound infilteration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional blockProcedure or surgery
Also called wound infilteration
In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.
Caudal blockProcedure or surgery
Also called infilteration with 0.25% bupivacaine
In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
EpiduralProcedure or surgery
Also called injection Bupivacaine into epidural space
In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000. Receives: Procedure: regional block; Procedure: Caudal block; Procedure: Epidural |
| Group B | Active comparator | In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site. Receives: Procedure: regional block; Procedure: Caudal block; Procedure: Epidural |
| Group C | Experimental | In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1. Receives: Procedure: regional block; Procedure: Caudal block; Procedure: Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age.
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 posted26 Apr 2024
- Study start5 Jan 2019
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C)
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Sharif, King Edward Medical University
- Investigators
- Muhammad Sharif, FCPS, Study chair, King edward Medical University/Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386250
- Sponsor's protocol ID
- 0005
- Acronym
- Painseverity
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Regional Block, Caudal Block and Wound Infiltration for Post-operative Pain Management in Children Undergoing Inguinal Herniotomy
- ClinicalTrials.gov ID
- NCT06386250
- Acronym / sponsor ID
- Painseverity / 0005
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, inguinal herniotomy, children, regional block, caudal block, wound infilteration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 26 Apr 2024 (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.
Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.
Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy
Detailed description
Three hundred patients rom the department of pediatric surgery, KEMU/Mayo Hospital, were randomized in three study groups by a computer generated table. Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C). . Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age. Patients were discharged after 24 hours. If pain score ≥ 4 was given intravenously, Ketoralac. Urinary retention was observed after 24 hours, wound infection was observed after 7 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C)
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: regional block, Procedure: Caudal block, Procedure: EpiduralIn group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000. |
| Group B | Active comparator | Procedure: regional block, Procedure: Caudal block, Procedure: EpiduralIn group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site. |
| Group C | Experimental | Procedure: regional block, Procedure: Caudal block, Procedure: EpiduralIn group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Both Male and female inguinal hernia patients
- Patients from 3-12 years age Exclusion Criteria
- 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.
Key exclusion criteria (0 listed)
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 blockAlso: wound infilterationIn group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000. | Procedure or surgery | Group A, Group B, Group C |
| Caudal blockAlso: infilteration with 0.25% bupivacaineIn group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site. | Procedure or surgery | Group A, Group B, Group C |
| EpiduralAlso: injection Bupivacaine into epidural spaceIn group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1. | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
Postoperative pain intensity
Time frame: 24 hours
Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age.
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 26 Apr 2024.
- Individual participant dataSharing planned: No. will be shared on request
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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.
Muhammad Sharif, FCPS study chair
King edward Medical University/Mayo Hospital Lahore
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, Caudal block and Epidural in people with Postoperative Pain, 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 4 inclusion and 0 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 26 Apr 2024. 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?
Postoperative pain intensity (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 26 Apr 2024.