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.
Phase 4
- Conditions
- Health Condition 1: Q549- Hypospadias, unspecified
- Registration Number
- CTRI/2019/03/018101
- Lead Sponsor
- Richa Rai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Postoperative <br/ ><br>surgical complications like urethrocutaneous fistula or glanular dehiscence. <br/ ><br>2.Postoperative pain assessment through FLACC Score (Face, Leg, Activity, Cry, Consolability) <br/ ><br>3.Duration of postoperative analgesiaTimepoint: Pain score will be recorded every 4 hourly postoperatively till 24 hours of surgery
- Secondary Outcome Measures
Name Time Method 1.Number of doses of rescue analgesics(paracetamol,iv morphine) used in the postoperative period. <br/ ><br>2.Side effects such as urinary retention, nausea <br/ ><br>and vomiting,sedation, <br/ ><br>respiratory depression and pruritus seenTimepoint: Recorded from end of surgery till 24 hours postoperatively