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NCT03812731
Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block
NA trial testing Ropivacaine in Distal Hypospadias in 30 participants. Completed in 28 November 2019.
28 November 2019
Quick facts
| Lead sponsor | Sir Ganga Ram Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 22 February 2019 |
| Primary completion | 28 November 2019 |
| Estimated completion | 28 November 2019 |
| Sites | 1 location across India |
Drugs / interventions tested
- Ropivacaine (ROPIVACAINE) — full drug profile →
- Fentanyl Citrate — full drug profile →
Conditions studied
- Distal Hypospadias — all drugs for Distal Hypospadias →
Sponsor
Sir Ganga Ram Hospital
Who can join
Adults 1 to 8, male only, with Distal Hypospadias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03812731
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Related trials
Other trials of Ropivacaine
Trials testing the same drug.
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- NCT07209345 — Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy · NA · recruiting
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- NCT07013526 — Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy · NA · not yet recruiting
- NCT06925789 — Influence of Standardized Perioperative Anesthetic, Analgesic Care on Outcome of Patients Undergoing Hip Fracture Surger · Phase 1 · withdrawn
Other recruiting trials for Distal Hypospadias
Currently open trials in the same condition.
- NCT07319780 — Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias · NA · recruiting
Other Sir Ganga Ram Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03812731 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sir Ganga Ram Hospital
- Last refreshed: 30 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03812731.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing