Postoperative PainNCT07747038
Caudal Block v/s Local Wound Infiltration for Pain Control in Pediatric Patients After Operation for Inguinal Hernia
A study testing Caudal Block with Ropivacaine Intervention, Local Wound Infiltration with Ropivacaine Intervention and Intravenous Paracetamol Suspension Intervention in people with Postoperative Pain, run by Fatima Memorial Hospital at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the analgesic efficacy of local wound infiltration with Ropivacaine versus Caudal Block with Ropivacaine in pediatric patients undergoing surgery for inguinal hernia Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Caudal Block with Ropivacaine Intervention, Local Wound Infiltration with Ropivacaine Intervention and Intravenous Paracetamol Suspension Intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 1 Jul 2026
- 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
- Male and female patients aged 2-10 years.
- Patients undergoing open elective herniotomy.
- Patients classified as ASA (American Society of Anesthesiologists) classes I and II.
Who cannot join
- Patients with recurrent, bilateral, complicated, or obstructed hernias.
- History of bleeding disorders.
- Presence of congenital anomalies of the spine.
- History of drug allergy.
- Infection at the caudal injection site.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Anesthesia, Fatima Memorial Hospital Lahore, Punjab, Pakistan, 54000
Lahore, Punjab Province
About this study
Official title: COMPARISON OF ANALGESIC EFFECTS OF WOUND INFILTRATION WITH ROPIVACAINE VERSUS CAUDAL BLOCK WITH ROPIVACAINE IN PEDIATRIC PATIENTS UNDERGOING INGUINAL HERNIOTOMY INTRODUCTION
This randomized controlled trial aims to compare the analgesic efficacy of local wound infiltration with Ropivacaine versus Caudal Block with Ropivacaine in pediatric patients undergoing surgery for inguinal hernia
Read the detailed description
Pediatric patients undergoing inguinal hernia surgeries experience postoperative pain. Conventional pain management methods, including opiates, may pose significant side effects. This study addresses the imperative need for optimizing postoperative pain management by systematically investigating and comparing the analgesic effects of local wound infiltration versus caudal block. The study involves 100 patients allocated into two equal groups using a lottery method: one group receiving caudal block; and other group local wound infiltration . Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
- Conditions
- Postoperative Pain
- Being tested
- Caudal Block with Ropivacaine Intervention, Local Wound Infiltration with Ropivacaine Intervention, Intravenous Paracetamol Suspension Intervention
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Block with Ropivacaine InterventionDrug
Administered after surgery using the landmark technique with 0.25% ropivacaine at a dose of 2mg/kg body weight.
Local Wound Infiltration with Ropivacaine InterventionDrug
Administered after surgery by pediatric surgeons using 0.5% ropivacaine at a dose of 2mg/kg body weight into the groin skin crease incision.
Intravenous Paracetamol Suspension InterventionDrug
Administered as rescue analgesia at a dose of 15 ml/kg body weight if the patient's postoperative pain score reaches 3 or higher on the Hannallah Modified Objective Pain Scale.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Caudal Block Group | Experimental | Pediatric patients undergoing open elective inguinal herniotomy who receive a post-operative caudal block. Receives: Drug: Caudal Block with Ropivacaine Intervention; Drug: Intravenous Paracetamol Suspension Intervention |
| Group B: Local wound infiltration | Active comparator | Pediatric patients undergoing open elective inguinal herniotomy who receive post-operative local wound infiltration. Receives: Drug: Local Wound Infiltration with Ropivacaine Intervention; Drug: Intravenous Paracetamol Suspension Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Analgesic Requirement
Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
Measured: Within first 8 hours after surgery
Postoperative Analgesia requirement
Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
Measured: Within first 8 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jul 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rimsha Zafar, Fatima Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747038
- Sponsor's protocol ID
- FMH-05/08/2025-IRB-1699
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF ANALGESIC EFFECTS OF WOUND INFILTRATION WITH ROPIVACAINE VERSUS CAUDAL BLOCK WITH ROPIVACAINE IN PEDIATRIC PATIENTS UNDERGOING INGUINAL HERNIOTOMY INTRODUCTION
- ClinicalTrials.gov ID
- NCT07747038
- Acronym / sponsor ID
- FMH-05/08/2025-IRB-1699
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fatima Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 5 Aug 2026 (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.
This randomized controlled trial aims to compare the analgesic efficacy of local wound infiltration with Ropivacaine versus Caudal Block with Ropivacaine in pediatric patients undergoing surgery for inguinal hernia
Detailed description
Pediatric patients undergoing inguinal hernia surgeries experience postoperative pain. Conventional pain management methods, including opiates, may pose significant side effects. This study addresses the imperative need for optimizing postoperative pain management by systematically investigating and comparing the analgesic effects of local wound infiltration versus caudal block. The study involves 100 patients allocated into two equal groups using a lottery method: one group receiving caudal block; and other group local wound infiltration . Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Caudal Block Group | Experimental | Drug: Caudal Block with Ropivacaine Intervention, Drug: Intravenous Paracetamol Suspension InterventionPediatric patients undergoing open elective inguinal herniotomy who receive a post-operative caudal block. |
| Group B: Local wound infiltration | Active comparator | Drug: Local Wound Infiltration with Ropivacaine Intervention, Drug: Intravenous Paracetamol Suspension InterventionPediatric patients undergoing open elective inguinal herniotomy who receive post-operative local wound infiltration. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male and female patients aged 2-10 years.
- Patients undergoing open elective herniotomy.
- Patients classified as ASA (American Society of Anesthesiologists) classes I and II.
Key exclusion criteria (5 listed)
- Patients with recurrent, bilateral, complicated, or obstructed hernias.
- History of bleeding disorders.
- Presence of congenital anomalies of the spine.
- History of drug allergy.
- Infection at the caudal injection site.
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 |
|---|---|---|
| Caudal Block with Ropivacaine InterventionAdministered after surgery using the landmark technique with 0.25% ropivacaine at a dose of 2mg/kg body weight. | Drug | Group A: Caudal Block Group |
| Local Wound Infiltration with Ropivacaine InterventionAdministered after surgery by pediatric surgeons using 0.5% ropivacaine at a dose of 2mg/kg body weight into the groin skin crease incision. | Drug | Group B: Local wound infiltration |
| Intravenous Paracetamol Suspension InterventionAdministered as rescue analgesia at a dose of 15 ml/kg body weight if the patient's postoperative pain score reaches 3 or higher on the Hannallah Modified Objective Pain Scale. | Drug | Group A: Caudal Block Group, Group B: Local wound infiltration |
Primary outcome
Postoperative Analgesic Requirement
Time frame: Within first 8 hours after surgery
Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
Postoperative Analgesia requirement
Time frame: Within first 8 hours after surgery
Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
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 5 Aug 2026.
- 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.
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 Caudal Block with Ropivacaine Intervention, Local Wound Infiltration with Ropivacaine Intervention and Intravenous Paracetamol Suspension Intervention in people with Postoperative Pain, run by Fatima Memorial Hospital 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 3 inclusion and 5 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 5 Aug 2026. 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 Analgesic Requirement (time frame: Within first 8 hours after surgery). 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 5 Aug 2026.