Postoperative PainPhase 4NCT03902249
Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair
A Phase 4 study testing Dexamethasone in people with Postoperative Pain and Hypospadias, run by Dr Sonia ben khalifa (PhD).
Trial summary
This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair. Read more about this study
- Who is it for?
- Ages 1 year to 18 years, men only
- Conditions the study is for
- Postoperative Pain, Hypospadias
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2018
- 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 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA physical status classification 1 or 2
- Procedure: hypospadias repair
- Eligible for a pudendal nerve block
Who cannot join
- parents or patient refusal
- nerve block failure
- Peroperative complication.
About this study
Official title: Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair
This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair.
Read the detailed description
It was a prospective study, randomized, double blind study, conducted at the Tunis Children's Hospital (January 2017-December 2018). After agreement with parents and the local ethics committee, the investigators included children aged 1 to 18 years, ASA 1-2, proposed for a hypospadias repair. Patients were randomized to: Group D receiving 0. 15mg/kg of Dexamethasone IV after induction and group P receiving the same volume of saline. The pudendal block was performed by neurostimulation after induction with Sevoflurane and 3 gamma/kg Fentanyl IV. The success of the block was tested at 10 and 15 minutes, it was declared successful when the systolic blood pressure and heart rate did not increase by more than 20% compared to the baseline values at the time of the incision. No analgesics were administered at the end of the surgery. The pain was assessed by the CHEOPS score the first 24 hours. The X2 test was used for qualitative variables and the student test for quantitative variables with P<0. 05 as the significance threshold. The number of patients required for the study was calculated (alpha=5% beta=90%) and was 62.
- Conditions
- Postoperative Pain, Hypospadias
- Being tested
- Dexamethasone
- Keywords
- Intravenous Dexamethasone, Pudendal nerve block, Analgesia, Postoperative pain, Children, Hypospadias
- Medical subject headings
- Pain, Postoperative, Hypospadias, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Active comparator | Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline Receives: Drug: Dexamethasone |
| Placebo group | Placebo comparator | Patients who received the same volume of saline as the study group (8ml) Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean time to first rescue analgesic
Time from the end of surgery to the first administration of rescue analgesic
Measured: The first 24 hours after surgery
number of rescue analgesic consumption
Total number of rescue analgesic consumption for each patient
Measured: The first 24 hours after surgery
Secondary outcomes (2)
pain scores (CHEOPS)
CHEOPS score ranges from 4 to 13. 13 is the worst score. If the score was superior to 7 rescue analgesia was administrated.
Measured: Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24
Number of episodes of postoperative nausea and vomiting
Number of episodes of postoperative nausea and vomiting in each patient
Measured: The first 24 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 posted4 Apr 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Sonia ben khalifa (PhD)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902249
- Sponsor's protocol ID
- DexaProtocol
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khalifa SB, Slimene AB, Blaiti H, Kaddour R, Hassen AF, Pardessus P, Brasher C, Dahmani S. The potentiating effect of intravenous dexamethasone upon preemptive pudendal block analgesia for hypospadias surgery in children managed with Snodgrass technique: a randomized controlled study : Dexamethasone for pain management in children. BMC Anesthesiol. 2024 Apr 16;24(1):145. doi: 10.1186/s12871-024-02536-3.
PubMed 38627668
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair
- ClinicalTrials.gov ID
- NCT03902249
- Acronym / sponsor ID
- DexaProtocol
- Conditions
- Postoperative Pain, Hypospadias
- Keywords
- Intravenous Dexamethasone, Pudendal nerve block, Analgesia, Postoperative pain, Children, Hypospadias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dr Sonia ben khalifa (PhD)University, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Apr 2019 (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 aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair.
Detailed description
It was a prospective study, randomized, double blind study, conducted at the Tunis Children's Hospital (January 2017-December 2018). After agreement with parents and the local ethics committee, the investigators included children aged 1 to 18 years, ASA 1-2, proposed for a hypospadias repair. Patients were randomized to: Group D receiving 0. 15mg/kg of Dexamethasone IV after induction and group P receiving the same volume of saline. The pudendal block was performed by neurostimulation after induction with Sevoflurane and 3 gamma/kg Fentanyl IV. The success of the block was tested at 10 and 15 minutes, it was declared successful when the systolic blood pressure and heart rate did not increase by more than 20% compared to the baseline values at the time of the incision. No analgesics were administered at the end of the surgery. The pain was assessed by the CHEOPS score the first 24 hours. The X2 test was used for qualitative variables and the student test for quantitative variables with P<0. 05 as the significance threshold. The number of patients required for the study was calculated (alpha=5% beta=90%) and was 62.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Active comparator | Drug: DexamethasonePatients who received 0.15mg/kg of Dexamethasone in 8ml of saline |
| Placebo group | Placebo comparator | Drug: DexamethasonePatients who received the same volume of saline as the study group (8ml) |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ASA physical status classification 1 or 2
- Procedure: hypospadias repair
- Eligible for a pudendal nerve block
Key exclusion criteria (3 listed)
- parents or patient refusal
- nerve block failure
- Peroperative complication.
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 |
|---|---|---|
| Dexamethasone | Drug | Dexamethasone group, Placebo group |
Primary outcome
The mean time to first rescue analgesic
Time frame: The first 24 hours after surgery
Time from the end of surgery to the first administration of rescue analgesic
number of rescue analgesic consumption
Time frame: The first 24 hours after surgery
Total number of rescue analgesic consumption for each patient
2 secondary outcomes
pain scores (CHEOPS)
Time frame: Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24
Number of episodes of postoperative nausea and vomiting
Time frame: The first 24 hours after surgery
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 4 Apr 2019.
- Derived from this study: PubMed 38627668Khalifa SB, Slimene AB, Blaiti H, Kaddour R, Hassen AF, Pardessus P, Brasher C, Dahmani S. The potentiating effect of intravenous dexamethasone upon preemptive pudendal block analgesia for hypospadias surgery in children managed with Snodgrass technique: a randomized controlled study : Dexamethasone for pain management in children. BMC Anesthesiol. 2024 Apr 16;24(1):145. doi: 10.1186/s12871-024-02536-3.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Postoperative Pain and Hypospadias, run by Dr Sonia ben khalifa (PhD).
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 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The mean time to first rescue analgesic (time frame: The first 24 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?
On the ClinicalTrials.gov record for NCT03902249, which also lists 1 linked publication.
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 4 Apr 2019.