PainPhase 1NCT07140627
COMPARISON OF BUPIVACAINE WITH AND WITHOUT DEXMEDETOMIDINE IN CAUDAL BLOCK AMONG CHILDREN UNDERGOING INGUINAL HERNIOTOMY
A Phase 1 study testing Bupivacain and Dexmedetomidine & Bupivacaine. in people with Pain and Rescue Analgesia, run by Allama Iqbal Medical College at 1 site in Pakistan.
Trial summary
A random controlled trial, was held at Jinnah Hospital in Lahore, consisting of 60 male pediatrics (6 months to 12 years), who were undergoing unilateral inguinal herniotomy or hydrocele repair. Read more about this study
- Who is it for?
- Ages 6 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Rescue Analgesia
- What is being tested?
- Bupivacain and Dexmedetomidine & Bupivacaine.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 31 Jan 2025
- Phase
- Phase 1
- 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 6 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Male children who were undergoing elective unilateral inguinal herniotomy or hydrocele surgery
Who cannot join
- Patients were excluded if they were already on analgesic (according to medical records)
- Obstructed inguinal hernias or bilateral hernias (confirmed through ultrasound)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Medical College/ Jinnah Hospital Lahore
Lahore, Punjab Province, 54550
About this study
A random controlled trial, was held at Jinnah Hospital in Lahore, consisting of 60 male pediatrics (6 months to 12 years), who were undergoing unilateral inguinal herniotomy or hydrocele repair. Patients were randomly allocated in two groups: Group A alone received 1 mL/kg 0.25% bupivacaine, while Group B received the same dose with 1 μg/kg dexmedetomidine. The pain score was evaluated by Wong-Beker Face Scale postoperatively every two hours, rescue analgesia (intravenous paracetamol 10 mg/kg) when the pain score reached ≥4
- Conditions
- Pain, Rescue Analgesia
- Being tested
- Bupivacain, Dexmedetomidine & Bupivacaine.
- Keywords
- Bupivacaine, Dexmedetomidine, Inguinal herniotomy, Rescue Analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. 30 participants had received 1 mL/kg 0.25% bupivacaine. Post operative pain was assessed.
Dexmedetomidine & Bupivacaine.Drug
A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. 30 participants were included and administered 1 mL/kg 0.25% bupivacaine and 1 μg/kg dexmedetomidine. Post operative pain was assessed.
| Study group | Role | What they receive |
|---|---|---|
| Group A with 0.25% Bupivacaine only | Experimental | After ethical approval, patients who met inclusion criteria were enrolled after obtaining written consent from their parents. Using computer-related random numbers, patients were allocated in two groups of 30: Group A Included 30 participants and received Bupivacaine alone. A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. The attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data. Receives: Drug: Bupivacain |
| Group B with 0.25% Bupivacaine and Dexmedetomidine | Experimental | After ethical approval, patients who met inclusion criteria were enrolled after obtaining written consent from their parents. Using computer-related random numbers, patients were allocated in two groups of 30: Group B Included 30 participants and received Bupivacaine alone. A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. The attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data. Receives: Drug: Dexmedetomidine & Bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pain
In both groups the attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data.
Measured: 2 hourly assessment for 8 hours on basis of pain score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Aug 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Muhammad Umer Iqbal Butt, MBBS FCPS, Principal investigator, Allama Iqbal Medical College/Jinnah Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140627
- Sponsor's protocol ID
- 65
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF BUPIVACAINE WITH AND WITHOUT DEXMEDETOMIDINE IN CAUDAL BLOCK AMONG CHILDREN UNDERGOING INGUINAL HERNIOTOMY
- ClinicalTrials.gov ID
- NCT07140627
- Acronym / sponsor ID
- 65
- Conditions
- Pain, Rescue Analgesia
- Keywords
- Bupivacaine, Dexmedetomidine, Inguinal herniotomy, Rescue Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Allama Iqbal Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 24 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.
A random controlled trial, was held at Jinnah Hospital in Lahore, consisting of 60 male pediatrics (6 months to 12 years), who were undergoing unilateral inguinal herniotomy or hydrocele repair. Patients were randomly allocated in two groups: Group A alone received 1 mL/kg 0.25% bupivacaine, while Group B received the same dose with 1 μg/kg dexmedetomidine. The pain score was evaluated by Wong-Beker Face Scale postoperatively every two hours, rescue analgesia (intravenous paracetamol 10 mg/kg) when the pain score reached ≥4
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A with 0.25% Bupivacaine only | Experimental | Drug: BupivacainAfter ethical approval, patients who met inclusion criteria were enrolled after obtaining written consent from their parents. Using computer-related random numbers, patients were allocated in two groups of 30: Group A Included 30 participants and received Bupivacaine alone. A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. The attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data. |
| Group B with 0.25% Bupivacaine and Dexmedetomidine | Experimental | Drug: Dexmedetomidine & Bupivacaine.After ethical approval, patients who met inclusion criteria were enrolled after obtaining written consent from their parents. Using computer-related random numbers, patients were allocated in two groups of 30: Group B Included 30 participants and received Bupivacaine alone. A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. The attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male children who were undergoing elective unilateral inguinal herniotomy or hydrocele surgery
Key exclusion criteria (2 listed)
- Patients were excluded if they were already on analgesic (according to medical records)
- Obstructed inguinal hernias or bilateral hernias (confirmed through ultrasound)
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 |
|---|---|---|
| BupivacainA 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. 30 participants had received 1 mL/kg 0.25% bupivacaine. Post operative pain was assessed. | Drug | Group A with 0.25% Bupivacaine only |
| Dexmedetomidine & Bupivacaine.A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. 30 participants were included and administered 1 mL/kg 0.25% bupivacaine and 1 μg/kg dexmedetomidine. Post operative pain was assessed. | Drug | Group B with 0.25% Bupivacaine and Dexmedetomidine |
Primary outcome
Post operative Pain
Time frame: 2 hourly assessment for 8 hours on basis of pain score
In both groups the attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data.
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 24 Aug 2025.
- 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.
Dr Muhammad Umer Iqbal Butt, MBBS FCPS principal investigator
Allama Iqbal Medical College/Jinnah Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacain and Dexmedetomidine & Bupivacaine. in people with Pain and Rescue Analgesia, run by Allama Iqbal Medical College 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 1 inclusion and 2 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 24 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Post operative Pain (time frame: 2 hourly assessment for 8 hours on basis of pain score). 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 24 Aug 2025.