Hernia RepairPhase 4NCT07121764
Postoperative Pain Relief in Children: Comparing Caudal Bupivacaine Alone Versus Bupivacaine With Dexmedetomidine for Infra-Umbilical Surgeries Under General Anesthesia
A Phase 4 study testing Bupivacaine %0.25 (isobaric) and Dexmedetomidine & Bupivacaine. in people with Hernia Repair and Orchiopexy, run by Allama Iqbal Teaching Hospital at 1 site in Pakistan.
Trial summary
This study is being done to find out which medicine combination provides better pain relief after surgery in children. Children who are having surgery below the belly button (called infra-umbilical surgery) will receive general anesthesia and a type of pain-blocking injection called a caudal block. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Hernia Repair, Orchiopexy, Hypospadias
- What is being tested?
- Bupivacaine %0.25 (isobaric) and Dexmedetomidine & Bupivacaine.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Apr 2025to 26 Jul 2025
- Phase
- Phase 4
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective infra-umbilical Surgeries
- ASA Status I and II
Who cannot join
- Chronic systemic illness (cardiovascular, pulmonary or renal disease, hepatic impairment)
- Allergy to local anesthetics
- Coagulation disorder
- Local skin infection
- Neuropathy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Teaching Hospital
Dera Ghazi Khan, Punjab Province, 32200
About this study
Official title: Comparison of Post-Operative Analgesia With Bupivacaine Alone Versus Bupivacaine and Dexmedetomidine, in Caudal Block for Infra-Umbilical Surgeries in Children
This study is being done to find out which medicine combination provides better pain relief after surgery in children. Children who are having surgery below the belly button (called infra-umbilical surgery) will receive general anesthesia and a type of pain-blocking injection called a caudal block. This block helps reduce pain after surgery.
The study will compare two types of caudal injections:
Read more
One group will receive Bupivacaine alone, a commonly used local anesthetic.
The other group will receive Bupivacaine combined with Dexmedetomidine, a medicine that might help the pain relief last longer.
The main question the researchers want to answer is:
Does adding Dexmedetomidine to Bupivacaine increase the duration of pain relief after surgery in children?
Researchers will also look at:
How long it takes before the child needs the first dose of pain medicine after surgery
How much pain medicine is used in the first 24 hours
How long any movement problems (motor block) last
Whether there are any side effects
Each child will be randomly assigned (like flipping a coin) to one of the two groups. The caudal block will be done after the surgery is completed, while the child is still under anesthesia. The nurse assessing the child's pain will not know which medicine the child received.
Children will be monitored for pain using a standard scoring system (FLACC scale) every few hours after surgery. If the pain score is high (7 or more), the child will receive intravenous paracetamol. Researchers will record how long the pain relief lasts, when the first pain medicine is needed, and the total amount of pain medicine used in the first 24 hours.
The study aims to help doctors choose the most effective and safe method to reduce post-surgery pain in children.
- Conditions
- Hernia Repair, Orchiopexy, Hypospadias
- Being tested
- Bupivacaine %0.25 (isobaric), Dexmedetomidine & Bupivacaine.
- Keywords
- Bupivacaine, Dexmedetomidine, Caudal block, Pediatrics, Postoperative analgesia
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine %0.25 (isobaric)Drug
1 ml/kg of 0.25% Bupivacaine will be used for caudal block.
Dexmedetomidine & Bupivacaine.Drug
1 ml/kg of 0.25% Bupivacaine PLUS 1 μg/kg Dexmedetomidine in 1 ml Normal Saline will be used for caudal block.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Active comparator | Bupivacaine alone Receives: Drug: Bupivacaine %0.25 (isobaric) |
| Combination therapy | Experimental | Bupivacaine with Dexmedetomidine Receives: Drug: Dexmedetomidine & Bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia Duration
Duration of post-operative pain free time (hours): time from surgery to FLACC score ≥7 needing rescue analgesia
Measured: From surgery to 24-hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start27 Apr 2025
- Primary completion26 Jul 2025
- Study completion26 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hernia RepairStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sajid Ullah, Allama Iqbal Teaching Hospital
- Investigators
- Syed A Abbas Naqvi, FCPS, Study chair, Allama Iqbal Teaching Hospital Dera Ghazi Khan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121764
- Sponsor's protocol ID
- U1111-1326-5938
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saadawy I, Boker A, Elshahawy MA, Almazrooa A, Melibary S, Abdellatif AA, Afifi W. Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics. Acta Anaesthesiol Scand. 2009 Feb;53(2):251-6. doi: 10.1111/j.1399-6576.2008.01818.x. Epub 2008 Dec 6.
PubMed 19076110Goyal V, Kubre J, Radhakrishnan K. Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children. Anesth Essays Res. 2016 May-Aug;10(2):227-32. doi: 10.4103/0259-1162.174468.
PubMed 27212752
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Operative Analgesia With Bupivacaine Alone Versus Bupivacaine and Dexmedetomidine, in Caudal Block for Infra-Umbilical Surgeries in Children
- ClinicalTrials.gov ID
- NCT07121764
- Acronym / sponsor ID
- U1111-1326-5938
- Conditions
- Hernia Repair, Orchiopexy, Hypospadias
- Keywords
- Bupivacaine, Dexmedetomidine, Caudal block, Pediatrics, Postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Allama Iqbal Teaching HospitalOther government
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 26 Jul 2025 (actual)
- First posted
- 13 Aug 2025 (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 study is being done to find out which medicine combination provides better pain relief after surgery in children. Children who are having surgery below the belly button (called infra-umbilical surgery) will receive general anesthesia and a type of pain-blocking injection called a caudal block. This block helps reduce pain after surgery.
The study will compare two types of caudal injections:
One group will receive Bupivacaine alone, a commonly used local anesthetic.
The other group will receive Bupivacaine combined with Dexmedetomidine, a medicine that might help the pain relief last longer.
The main question the researchers want to answer is:
Does adding Dexmedetomidine to Bupivacaine increase the duration of pain relief after surgery in children?
Researchers will also look at:
How long it takes before the child needs the first dose of pain medicine after surgery
How much pain medicine is used in the first 24 hours
How long any movement problems (motor block) last
Whether there are any side effects
Each child will be randomly assigned (like flipping a coin) to one of the two groups. The caudal block will be done after the surgery is completed, while the child is still under anesthesia. The nurse assessing the child's pain will not know which medicine the child received.
Children will be monitored for pain using a standard scoring system (FLACC scale) every few hours after surgery. If the pain score is high (7 or more), the child will receive intravenous paracetamol. Researchers will record how long the pain relief lasts, when the first pain medicine is needed, and the total amount of pain medicine used in the first 24 hours.
The study aims to help doctors choose the most effective and safe method to reduce post-surgery pain in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Active comparator | Drug: Bupivacaine %0.25 (isobaric)Bupivacaine alone |
| Combination therapy | Experimental | Drug: Dexmedetomidine & Bupivacaine.Bupivacaine with Dexmedetomidine |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Elective infra-umbilical Surgeries
- ASA Status I and II
Key exclusion criteria (5 listed)
- Chronic systemic illness (cardiovascular, pulmonary or renal disease, hepatic impairment)
- Allergy to local anesthetics
- Coagulation disorder
- Local skin infection
- Neuropathy
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 |
|---|---|---|
| Bupivacaine %0.25 (isobaric)1 ml/kg of 0.25% Bupivacaine will be used for caudal block. | Drug | Monotherapy |
| Dexmedetomidine & Bupivacaine.1 ml/kg of 0.25% Bupivacaine PLUS 1 μg/kg Dexmedetomidine in 1 ml Normal Saline will be used for caudal block. | Drug | Combination therapy |
Primary outcome
Analgesia Duration
Time frame: From surgery to 24-hours post operatively
Duration of post-operative pain free time (hours): time from surgery to FLACC score ≥7 needing rescue analgesia
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 Aug 2025.
- Background: PubMed 19076110Saadawy I, Boker A, Elshahawy MA, Almazrooa A, Melibary S, Abdellatif AA, Afifi W. Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics. Acta Anaesthesiol Scand. 2009 Feb;53(2):251-6. doi: 10.1111/j.1399-6576.2008.01818.x. Epub 2008 Dec 6.
- Background: PubMed 27212752Goyal V, Kubre J, Radhakrishnan K. Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children. Anesth Essays Res. 2016 May-Aug;10(2):227-32. doi: 10.4103/0259-1162.174468.
- 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.
Syed A Abbas Naqvi, FCPS study chair
Allama Iqbal Teaching Hospital Dera Ghazi Khan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine %0.25 (isobaric) and Dexmedetomidine & Bupivacaine. in people with Hernia Repair and Orchiopexy, run by Allama Iqbal Teaching 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 2 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 13 Aug 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Analgesia Duration (time frame: From surgery to 24-hours post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07121764, which also lists 2 linked publications.
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 Aug 2025.