Hypospadias and EpispadiasNCT03145415
Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children
A study testing Caudal block and Bilateral Pudendal block in people with Hypospadias and Epispadias, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair. Read more about this study
- Who is it for?
- Ages 6 months to 2 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias and Epispadias
- What is being tested?
- Caudal block and Bilateral Pudendal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 20 Dec 2019
- 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 6 months to 2 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Boys undergoing hypospadias repair
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours/ duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial
The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.
Read the detailed description
Hypospadias repair is one of the most common congenital malformations of the penis in the United States. It has an incidence of about 1 in 300 births. A combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair.
In our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. A comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.
- Conditions
- Hypospadias and Epispadias
- Being tested
- Caudal block, Bilateral Pudendal block
- Keywords
- pudendal nerve block, hypospadias, caudal block
- Medical subject headings
- Hypospadias, Epispadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal blockProcedure or surgery
1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.
Bilateral Pudendal blockProcedure or surgery
0.5 cc per kg of 0.2% ropivicaine. Half of the volume given as a right pudendal block and the remaining volume given on the left pudendal nerve block given prior to the start of surgery
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Pudendal block | Experimental | 0.25 cc per kg of 0.2% ropivacaine will be injected once for right pudendal N block and the same volume for the left pudendal N block before the start of the surgery Receives: Procedure: Bilateral Pudendal block |
| Caudal block | Active comparator | 1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery Receives: Procedure: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
The child's care giver will document the times that a rescue opioid was given to relieve pain.
Measured: up to 24 hours
Secondary outcomes (2)
Intraoperative block assessment
A heart rate increase above of 20 percent of baseline will be an indication of inadequate block that will be treated with a rescue opioid.
Measured: up to 3 hours
Post operative pain
The FLACC scale scores greater than 6 will be an indication of inadequate pain relief needing a rescue dosages of opioid.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start17 Feb 2017
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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 Hypospadias and EpispadiasStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145415
- Sponsor's protocol ID
- lh0001
- Status last verified
- Apr 2017
- First submitted
- 3 May 2017
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choudhry DK, Heredia L, Brenn BR, Brown M, Carvalho NF, Whaley MC, Shaik SS, Hagerty JA, Bani Hani A. Nerve stimulation guided bilateral pudendal nerve block versus landmark-based caudal block for hypospadias repair in young children: a prospective, randomized, pragmatic trial. Reg Anesth Pain Med. 2022 Dec;47(12):744-748. doi: 10.1136/rapm-2022-103680. Epub 2022 Sep 8.
PubMed 36283712
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT03145415
- Acronym / sponsor ID
- lh0001
- Conditions
- Hypospadias and Epispadias
- Keywords
- pudendal nerve block, hypospadias, caudal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 9 May 2017 (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.
The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.
Detailed description
Hypospadias repair is one of the most common congenital malformations of the penis in the United States. It has an incidence of about 1 in 300 births. A combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair.
In our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. A comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.
| Arm | Type | Receives |
|---|---|---|
| Bilateral Pudendal block | Experimental | Procedure: Bilateral Pudendal block0.25 cc per kg of 0.2% ropivacaine will be injected once for right pudendal N block and the same volume for the left pudendal N block before the start of the surgery |
| Caudal block | Active comparator | Procedure: Caudal block1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Boys undergoing hypospadias repair
Key exclusion criteria (1 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 |
|---|---|---|
| Caudal block1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery. | Procedure or surgery | Caudal block |
| Bilateral Pudendal block0.5 cc per kg of 0.2% ropivicaine. Half of the volume given as a right pudendal block and the remaining volume given on the left pudendal nerve block given prior to the start of surgery | Procedure or surgery | Bilateral Pudendal block |
Primary outcome
Opioid consumption
Time frame: up to 24 hours
The child's care giver will document the times that a rescue opioid was given to relieve pain.
2 secondary outcomes
Intraoperative block assessment
Time frame: up to 3 hours
Post operative pain
Time frame: up to 2 hours
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 19 May 2022.
- Derived from this study: PubMed 36283712Choudhry DK, Heredia L, Brenn BR, Brown M, Carvalho NF, Whaley MC, Shaik SS, Hagerty JA, Bani Hani A. Nerve stimulation guided bilateral pudendal nerve block versus landmark-based caudal block for hypospadias repair in young children: a prospective, randomized, pragmatic trial. Reg Anesth Pain Med. 2022 Dec;47(12):744-748. doi: 10.1136/rapm-2022-103680. Epub 2022 Sep 8.
- Individual participant dataSharing planned: No
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 and Bilateral Pudendal block in people with Hypospadias and Epispadias, run by Nemours Children's Clinic at 1 site in United States.
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 1 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 19 May 2022. 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 United States. 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?
Opioid consumption (time frame: up to 24 hours). 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 NCT03145415, 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 19 May 2022.