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A study to compare the effect of two drug combinations that is Bupivacaine with Morphine and Morphine only by giving these drugs for numbing the nerves supplying that required area (caudal block) in surgery of male genital organ abnormality.

A COMPARATIVE STUDY OF THE EFFECT OF CAUDAL BLOCK WITH BUPIVACAINE- MORPHINE VERSUS MORPHINE ONLY FOR HYPOSPADIAS SURGERY - A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018101
Enrollment
100
Registered
2019-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q549- Hypospadias, unspecified

Interventions

Intervention1: 50 mcg/kg of Morphine diluted to a volume of 0.5 ml/kg: This drug will be administered through caudal block after induction of anaesthesia but before the start of the surgery Control In

Sponsors

Richa Rai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA grade 1 and 2 2.Parents giving consent for participating in study 3.Primary, single-stage hypospadias repair surgery

Exclusion criteria

Exclusion criteria: 1.Planned 2-stage repairs, revision surgeries 2.Known allergy to bupivacaine and morphine 3.Renal, hepatic, or cardiovascular dysfunction, neurological disorders,. 4.History of mental retardation or delayed milestones 5.Suspected coagulopathy 6.Parents refusal to participate in the study 7.Local site infection 8.Spinal deformity

Design outcomes

Primary

MeasureTime frame
1.Postoperative surgical complications like urethrocutaneous fistula or glanular dehiscence. 2.Postoperative pain assessment through FLACC Score (Face, Leg, Activity, Cry, Consolability) 3.Duration of postoperative analgesiaTimepoint: Pain score will be recorded every 4 hourly postoperatively till 24 hours of surgery

Secondary

MeasureTime frame
1.Number of doses of rescue analgesics(paracetamol,iv morphine) used in the postoperative period. 2.Side effects such as urinary retention, nausea and vomiting,sedation, respiratory depression and pruritus seenTimepoint: Recorded from end of surgery till 24 hours postoperatively

Countries

India

Contacts

Public ContactRicha Rai

Institute of Medical Sciences- Banaras Hindu University

richasgpgi@gmail.com9452516982

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026