Distal HypospadiasNCT03812731
Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block
A study testing Ropivacaine and Fentanyl Citrate in people with Distal Hypospadias, run by Sir Ganga Ram Hospital at 1 site in India.
Trial summary
The study is designed to explore any association between the caudal epidural block(CEB) given for perioperative analgesia and the occurrence of urethrocutaneous fistula postoperatively in children undergoing distal hypospadias repair .We also intend to study the duration of penile engorgement due to CEB causing penile… Read more about this study
- Who is it for?
- Ages 1 year to 8 years, men only
- Conditions the study is for
- Distal Hypospadias
- What is being tested?
- Ropivacaine and Fentanyl Citrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 22 Feb 2019to 28 Nov 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 1 year to 8 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male children l
- 1 to 8 years of age
- ASA physical status I and II
- Distal hypospadias -
Who cannot join
- Simultaneously undergoing any other procedure
- Local infection in sacral region
- Bleeding diathesis
- Preoperative testosterone stimulation
Trial locations and contacts
1 site in 1 country.
India1 site
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
About this study
Official title: Incidence of Urethrocutaneous Fistula Following Distal Hypospadias Repair With and Without Caudal Epidural Block - A Pilot Study
The study is designed to explore any association between the caudal epidural block(CEB) given for perioperative analgesia and the occurrence of urethrocutaneous fistula postoperatively in children undergoing distal hypospadias repair .We also intend to study the duration of penile engorgement due to CEB causing penile oedema which may subsequently play a role in fistula formation. The pilot study will recruit children under 8 years of age diagnosed with distal hypospadias scheduled to undergo Tubularised Incised Plate Urethroplasty, operated by a single paediatric surgeon. General anaesthesia will be induced with sevoflurane in oxygen nitrous oxide mixture supplemented by fentanyl citrate and atracurium besylate in all children. LMA Pro SealTMof appropriate size will be inserted. Children in group I will then be given caudal epidural block (CEB) as per our practice protocol. Children in group II will be given additional intravenous fentanyl citrate. All children will be followed postoperatively till 3 months to evaluate incidence of urethtocutaneous fistula. The prospective study attempts to eliminate previously reported confounding factors.
Read the detailed description
CEB is routinely used along with general anaesthesia for inguinal and genital surgeries. It provides intraoperative and postoperative analgesia, is safe, simple and has success rate of more than 90% in children.It decreases the requirement of inhalational anaesthetics and narcotics, decreases stress hormone release and facilitates early recovery. Hypospadias is the most common congenital anomaly of penis, incidence being 1 in 300 live births. Hypospadias repair is a technical procedure that can be associated with significant complications such as meatal stenosis, stricture, glans dehiscence and flap necrosis Urethrocutaneous fisula formation is the most common complication after primary repair with an incidence of upto 20%. There have been controversies regarding the association of CEB with urethrocutaneous fistula. Some studies have reported a high incidence of postoperative urethrocutaneous fistula in children who received CEB while others have not confirmed any such relationship. Association between urethrocutaneous fistula and site of urethral opening, age of patient, duration of surgery, surgeon's expertise, use of subcutaneous epinephrine and use of preoperative testosterone has been found. Penile engorgement, post inflammatory response and tissue oedema may be contributory factors for development of fistula. However any association between CEB and fistula formation is not clear. All studies, except one, are retrospective, limited by small sample size and presence of various confounding factors. The present study is aimed to explore any association between CEB and urethrocutaneous fistula. The study will be conducted in children with distal hypospadias only; they will be operated by a single surgeon, without the use of subcutaneous epinephrine, so that any association, if at all between CEB and urethrocutaneous fistula becomes evident.
- Conditions
- Distal Hypospadias
- Being tested
- Ropivacaine, Fentanyl Citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Intraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg
Fentanyl CitrateDrug
Intraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered
| Study group | Role | What they receive |
|---|---|---|
| Caudal Group | Active comparator | Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2 mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.
Children in will then receive CEB with 0.2 % ropivacaine 1-ml/kg for maintaining analgesia Receives: Drug: Ropivacaine |
| Non- Caudal Group | Active comparator | Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2-mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.
Children in will then receive fentanyl citrate 1-mcg/kg/hr for maintaining analgesia Receives: Drug: Fentanyl Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urethrocutaneous fistula
Patients undergoing distal hypospadias repair will be followed up for occurrence of uretherocutaneous fistula
Measured: From one day after surgery(0-hours, baseline) till 3-months post surgery
Secondary outcomes (5)
Penile Engorgement
Length of penis from pubic bone to glans tip and mid shaft circumference i.e. girth around the widest part of the penile shaft will be calculated
Measured: After induction of anaesthesia (0-hours, baseline) till end of surgery
Changes in intra-operative heart rate (beats per minute)
Comparison of intra-operative heart rate between both the arms will be done
Measured: From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively
Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)
Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done
Measured: rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively
Postoperative analgesia requirement
Additional fentanyl citrate 0.5-mcg/kg will be administered intravenously if the Face, Legs, Activity, Cry, Consolability scale (FLACC scale) score is > 3 and total amount administered will be recorded
Measured: From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively
Incidence of complications
Complications of surgery such as infection, bleeding , hematoma, glans dehiscence, skin or flap necrosis will be noted
Measured: From end of anaesthesia (0-hours, baseline) till 3-months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start22 Feb 2019
- Primary completion28 Nov 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal HypospadiasStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 male patients aged 1-8 years, ASA physical status I/II, and undergoing distal hypospadias repair will be randomly allocated to one of the following two groups: GROUP I- (Caudal group, n= 15) Children will receive general anesthesia (GA) and analgesia will be maintained with caudal epidural block (CEB) with 0.2% ropivacaine:1 ml/kg. GROUP II- (Non-caudal group, n= 15) Children will receive general anaesthesia (GA) and analgesia will be maintained with intravenous fentanyl citrate 1mcg/kg/hr. roup-1 \[CLADS Group, n=60\]: Anaesthesia will be induced and maintained with propofol administered using the BIS feedback-based automated CLADS. Group-2 \[Desflurane Group, n=60\]: Anaesthesia will be induced with propofol CLADS and will be maintained intraoperatively by Desflurane titrated to BIS monitoring.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nitin Sethi, Sir Ganga Ram Hospital
- Investigators
- Deepali Shukla, DA, Principal investigator, Sir Ganga Ram HospitalArchna Koul, MS, MCH, Study director, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812731
- Sponsor's protocol ID
- EC/01/19/1478
- Status last verified
- Oct 2020
- First submitted
- 19 Jan 2019
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Urethrocutaneous Fistula Following Distal Hypospadias Repair With and Without Caudal Epidural Block - A Pilot Study
- ClinicalTrials.gov ID
- NCT03812731
- Acronym / sponsor ID
- EC/01/19/1478
- Conditions
- Distal Hypospadias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 23 Jan 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.
The study is designed to explore any association between the caudal epidural block(CEB) given for perioperative analgesia and the occurrence of urethrocutaneous fistula postoperatively in children undergoing distal hypospadias repair .We also intend to study the duration of penile engorgement due to CEB causing penile oedema which may subsequently play a role in fistula formation. The pilot study will recruit children under 8 years of age diagnosed with distal hypospadias scheduled to undergo Tubularised Incised Plate Urethroplasty, operated by a single paediatric surgeon. General anaesthesia will be induced with sevoflurane in oxygen nitrous oxide mixture supplemented by fentanyl citrate and atracurium besylate in all children. LMA Pro SealTMof appropriate size will be inserted. Children in group I will then be given caudal epidural block (CEB) as per our practice protocol. Children in group II will be given additional intravenous fentanyl citrate. All children will be followed postoperatively till 3 months to evaluate incidence of urethtocutaneous fistula. The prospective study attempts to eliminate previously reported confounding factors.
Detailed description
CEB is routinely used along with general anaesthesia for inguinal and genital surgeries. It provides intraoperative and postoperative analgesia, is safe, simple and has success rate of more than 90% in children.It decreases the requirement of inhalational anaesthetics and narcotics, decreases stress hormone release and facilitates early recovery. Hypospadias is the most common congenital anomaly of penis, incidence being 1 in 300 live births. Hypospadias repair is a technical procedure that can be associated with significant complications such as meatal stenosis, stricture, glans dehiscence and flap necrosis Urethrocutaneous fisula formation is the most common complication after primary repair with an incidence of upto 20%. There have been controversies regarding the association of CEB with urethrocutaneous fistula. Some studies have reported a high incidence of postoperative urethrocutaneous fistula in children who received CEB while others have not confirmed any such relationship. Association between urethrocutaneous fistula and site of urethral opening, age of patient, duration of surgery, surgeon's expertise, use of subcutaneous epinephrine and use of preoperative testosterone has been found. Penile engorgement, post inflammatory response and tissue oedema may be contributory factors for development of fistula. However any association between CEB and fistula formation is not clear. All studies, except one, are retrospective, limited by small sample size and presence of various confounding factors. The present study is aimed to explore any association between CEB and urethrocutaneous fistula. The study will be conducted in children with distal hypospadias only; they will be operated by a single surgeon, without the use of subcutaneous epinephrine, so that any association, if at all between CEB and urethrocutaneous fistula becomes evident.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 30 male patients aged 1-8 years, ASA physical status I/II, and undergoing distal hypospadias repair will be randomly allocated to one of the following two groups: GROUP I- (Caudal group, n= 15) Children will receive general anesthesia (GA) and analgesia will be maintained with caudal epidural block (CEB) with 0.2% ropivacaine:1 ml/kg. GROUP II- (Non-caudal group, n= 15) Children will receive general anaesthesia (GA) and analgesia will be maintained with intravenous fentanyl citrate 1mcg/kg/hr. roup-1 [CLADS Group, n=60]: Anaesthesia will be induced and maintained with propofol administered using the BIS feedback-based automated CLADS. Group-2 [Desflurane Group, n=60]: Anaesthesia will be induced with propofol CLADS and will be maintained intraoperatively by Desflurane titrated to BIS monitoring.
| Arm | Type | Receives |
|---|---|---|
| Caudal Group | Active comparator | Drug: RopivacaineChildren will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2 mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted. Children in will then receive CEB with 0.2 % ropivacaine 1-ml/kg for maintaining analgesia |
| Non- Caudal Group | Active comparator | Drug: Fentanyl CitrateChildren will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2-mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted. Children in will then receive fentanyl citrate 1-mcg/kg/hr for maintaining analgesia |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male children l
- 1 to 8 years of age
- ASA physical status I and II
- Distal hypospadias -
Key exclusion criteria (4 listed)
- Simultaneously undergoing any other procedure
- Local infection in sacral region
- Bleeding diathesis
- Preoperative testosterone stimulation
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 |
|---|---|---|
| RopivacaineIntraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg | Drug | Caudal Group |
| Fentanyl CitrateIntraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered | Drug | Non- Caudal Group |
Primary outcome
Incidence of urethrocutaneous fistula
Time frame: From one day after surgery(0-hours, baseline) till 3-months post surgery
Patients undergoing distal hypospadias repair will be followed up for occurrence of uretherocutaneous fistula
5 secondary outcomes
Penile Engorgement
Time frame: After induction of anaesthesia (0-hours, baseline) till end of surgery
Changes in intra-operative heart rate (beats per minute)
Time frame: From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively
Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)
Time frame: rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively
Postoperative analgesia requirement
Time frame: From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively
Incidence of complications
Time frame: From end of anaesthesia (0-hours, baseline) till 3-months postoperatively
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 30 Oct 2020.
- Individual participant dataSharing planned: No
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Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
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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.
Deepali Shukla, DA principal investigator
Sir Ganga Ram Hospital
Archna Koul, MS, MCH study director
Sir Ganga Ram Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and Fentanyl Citrate in people with Distal Hypospadias, run by Sir Ganga Ram Hospital at 1 site in India.
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 4 inclusion and 4 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 30 Oct 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 India. 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?
Incidence of urethrocutaneous fistula (time frame: From one day after surgery(0-hours, baseline) till 3-months post surgery). 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 30 Oct 2020.