Regional AnesthesiaNCT04668183
Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
An observational study of Regional Anesthesia and Hypospadias, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Hypospadias repair is a urological surgical operation that is very painful in the postoperative period and requires long-term analgesia. A dorsal penial nerve block (DPNB) and pudendal nerve block (PNB), which are regional anesthesia techniques for this operation, are used to provide postoperative analgesia. Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia, Hypospadias
- What is being tested?
- Pudendal nerve block group and Dorsal penile nerve block group
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Aug 2020
- Phase
- Observational
- 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 7 years
- Men only
- Healthy volunteers accepted
- Child
Study population: The study was conducted with children who underwent hypospadias surgery at a training and research hospital in Istanbul, Turkey.
Who may be able to join
- Male patients aged between 1-7 years
- American Society of Anesthesiologists (ASA) I-II group
- Distal hypospadias surgery
- Able to communicate in Turkish
- Willing to participate to the study (parents and children)
Who cannot join
- Less than 1 or more than 7 years of age
- A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
- Unwilling to to participate to the study ((parents or children)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
Official title: Ultrasound-guided Pudendal Nerve Block Versus Ultrasound-guided Dorsal Penile Nerve Block for Pediatric Distal Hypospadias Surgery
Hypospadias repair is a urological surgical operation that is very painful in the postoperative period and requires long-term analgesia. A dorsal penial nerve block (DPNB) and pudendal nerve block (PNB), which are regional anesthesia techniques for this operation, are used to provide postoperative analgesia.
Read the detailed description
The regional anesthesia techniques used for postoperative analgesia in hypospadias repair include the peripheral nerve blocks of pudendal nerve block (PNB) and dorsal penile nerve block (DPNB). Ultrasound (US) has recently become increasingly popular in regional anesthesia practice and is used to aid these two peripheral nerve block applications in various pediatric urological procedures. US-guided DPNB has been shown to provide effective and long-term analgesia when compared to caudal epidural block in a recent study on hypospadias surgery in the pediatric population.
- Conditions
- Regional Anesthesia, Hypospadias
- Being tested
- Pudendal nerve block group, Dorsal penile nerve block group
- Keywords
- Postoperative pain, Ultrasound, Dorsal penile nerve block, Pudendal nerve block, Hypospadias
- Medical subject headings
- Hypospadias, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal nerve block groupProcedure or surgery
A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.
Dorsal penile nerve block groupProcedure or surgery
Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis.
| Study group | Role | What they receive |
|---|---|---|
| Pudendal Nerve Block | Linear ultrasound probe and the sacral hiatus at the sacral cornu level was visualized using an out-of-plane transverse view at 5-10 megahertz . The linear probe was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone. Receives: Procedure: Pudendal nerve block group | |
| Dorsal Penile Nerve Block | Ultrasound (US) guided dorsal penile nerve block with in plane technique was done. Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis. Receives: Procedure: Dorsal penile nerve block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Postoperative analgesic requirement
It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 7 or higher.
Measured: Up to 24 hours
Secondary outcomes (3)
Level of Postoperative pain
It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse
Measured: Up to 24 hours]
Rate of Postoperative complications
The presence of penile edema or an injection site ecchymosis or hematoma was evaluated by an anesthesiologist blinded to the study groups postoperatively (at 30 minutes and 1, 2, 6, 12, 18 and 24 hours).
Measured: Up to 24 hours
Level of Parent satisfaction
The parents were asked about their satisfaction with the child's comfort and activity level [1, unsatisfied; 2, satisfied (good); 3, absolutely satisfied (excellent)] at the 24-hour follow-up
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Nov 2019
- Primary completion1 Apr 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Ozen, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Volkan Ozen, MD, Study director, Prof. Dr. Cemil Tascıoglu City Hospital, Istanbul, Şişli, Turkey, 34384
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668183
- Sponsor's protocol ID
- 1457
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.
PubMed 32507565Alizadeh F, Heydari SM, Nejadgashti R. Effectiveness of caudal epidural block on interaoperative blood loss during hypospadias repair: A randomized clinical trial. J Pediatr Urol. 2018 Oct;14(5):420.e1-420.e5. doi: 10.1016/j.jpurol.2018.03.025. Epub 2018 May 21.
PubMed 29858133Saavedra-Belaunde JA, Soto-Aviles O, Jorge J, Escudero K, Vazquez-Cruz M, Perez-Brayfield M. Can regional anesthesia have an effect on surgical outcomes in patients undergoing distal hypospadia surgery? J Pediatr Urol. 2017 Feb;13(1):45.e1-45.e4. doi: 10.1016/j.jpurol.2016.09.011. Epub 2016 Oct 26.
PubMed 27956108
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Pudendal Nerve Block Versus Ultrasound-guided Dorsal Penile Nerve Block for Pediatric Distal Hypospadias Surgery
- ClinicalTrials.gov ID
- NCT04668183
- Acronym / sponsor ID
- 1457
- Conditions
- Regional Anesthesia, Hypospadias
- Keywords
- Postoperative pain, Ultrasound, Dorsal penile nerve block, Pudendal nerve block, Hypospadias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 16 Dec 2020 (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.
Hypospadias repair is a urological surgical operation that is very painful in the postoperative period and requires long-term analgesia. A dorsal penial nerve block (DPNB) and pudendal nerve block (PNB), which are regional anesthesia techniques for this operation, are used to provide postoperative analgesia.
Detailed description
The regional anesthesia techniques used for postoperative analgesia in hypospadias repair include the peripheral nerve blocks of pudendal nerve block (PNB) and dorsal penile nerve block (DPNB). Ultrasound (US) has recently become increasingly popular in regional anesthesia practice and is used to aid these two peripheral nerve block applications in various pediatric urological procedures. US-guided DPNB has been shown to provide effective and long-term analgesia when compared to caudal epidural block in a recent study on hypospadias surgery in the pediatric population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pudendal Nerve Block | – | Procedure: Pudendal nerve block groupLinear ultrasound probe and the sacral hiatus at the sacral cornu level was visualized using an out-of-plane transverse view at 5-10 megahertz . The linear probe was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone. |
| Dorsal Penile Nerve Block | – | Procedure: Dorsal penile nerve block groupUltrasound (US) guided dorsal penile nerve block with in plane technique was done. Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study was conducted with children who underwent hypospadias surgery at a training and research hospital in Istanbul, Turkey.
Key inclusion criteria (5 listed)
- Male patients aged between 1-7 years
- American Society of Anesthesiologists (ASA) I-II group
- Distal hypospadias surgery
- Able to communicate in Turkish
- Willing to participate to the study (parents and children)
Key exclusion criteria (3 listed)
- Less than 1 or more than 7 years of age
- A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
- Unwilling to to participate to the study ((parents or children)
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 |
|---|---|---|
| Pudendal nerve block groupA 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures. | Procedure or surgery | Pudendal Nerve Block |
| Dorsal penile nerve block groupHalf of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis. | Procedure or surgery | Dorsal Penile Nerve Block |
Primary outcome
Time of Postoperative analgesic requirement
Time frame: Up to 24 hours
It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 7 or higher.
3 secondary outcomes
Level of Postoperative pain
Time frame: Up to 24 hours]
Rate of Postoperative complications
Time frame: Up to 24 hours
Level of Parent satisfaction
Time frame: Up to 24 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 16 Dec 2020.
- Background: PubMed 32507565Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.
- Background: PubMed 29858133Alizadeh F, Heydari SM, Nejadgashti R. Effectiveness of caudal epidural block on interaoperative blood loss during hypospadias repair: A randomized clinical trial. J Pediatr Urol. 2018 Oct;14(5):420.e1-420.e5. doi: 10.1016/j.jpurol.2018.03.025. Epub 2018 May 21.
- Background: PubMed 27956108Saavedra-Belaunde JA, Soto-Aviles O, Jorge J, Escudero K, Vazquez-Cruz M, Perez-Brayfield M. Can regional anesthesia have an effect on surgical outcomes in patients undergoing distal hypospadia surgery? J Pediatr Urol. 2017 Feb;13(1):45.e1-45.e4. doi: 10.1016/j.jpurol.2016.09.011. Epub 2016 Oct 26.
- 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.
Volkan Ozen, MD study director
Prof. Dr. Cemil Tascıoglu City Hospital, Istanbul, Şişli, Turkey, 34384
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia and Hypospadias, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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 5 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 16 Dec 2020. 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 Turkey (Türkiye). 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?
Time of Postoperative analgesic requirement (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 NCT04668183, which also lists 3 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 16 Dec 2020.