CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 22:54:42 GMT)

CTRI Number CTRI/2019/03/018101 [Registered on: 15/03/2019] - Trial Registered Prospectively Last Modified On 11/03/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Surgical/Anesthesia Study Design Randomized, Parallel Group Trial Public Title of Study 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. Scientific Title of A COMPARATIVE STUDY OF THE EFFECT OF CAUDAL BLOCK WITH BUPIVACAINE- Study MORPHINE VERSUS MORPHINE ONLY FOR HYPOSPADIAS SURGERY - A RANDOMIZED CONTROLLED TRIAL Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Richa Rai Trial Coordinator (multi-center study) Designation senior resident Affiliation Institute of Medical Sciences- Banaras Hindu University Address Department of Anesthesiology, Sir Sunderlal Hospital, Institute of Medical Sciences- Banaras Hindu University(IMS-BHU) Varanasi. Varanasi UTTAR PRADESH 221005 India Phone 9452516982 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Richa Rai Query) Designation senior resident Affiliation Institute of Medical Sciences- Banaras Hindu University Address Department of Anesthesiology, Sir Sunderlal Hospital, Institute of Medical Sciences- Banaras Hindu University(IMS-BHU) Varanasi.

UTTAR PRADESH 221005 India Phone 9452516982 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Richa Rai Designation senior resident Affiliation Institute of Medical Sciences- Banaras Hindu University Address Department of Anesthesiology, Sir Sunderlal Hospital, Institute of Medical Sciences- Banaras Hindu University(IMS-BHU) Varanasi.

UTTAR PRADESH

page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in

221005 India Phone 9452516982 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > SELF Primary Sponsor Primary Sponsor Details Name Richa Rai Address Department of Anesthesiology, Sir Sunderlal Hopital, Institute of Medical Sciences-Banaras Hindu University(IMS-BHU), Varanasi, Uttar Pradesh. Type of Sponsor Other [self] Details of Secondary Name Address Sponsor NONE Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Richa Rai Sir Sunderlal Hospital Department of Pediatric 9452516982 Surgery, Operating Room 1 and 2, Institute [email protected] of Medical Sciences-Banaras Hindu University(IMS-BHU), Varanasi Varanasi UTTAR PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 08/03/2019 No Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Hypospadias, unspecified Intervention / Type Name Details Comparator Agent Comparator Agent 0.5 ml/kg of 0.25% plain This drug combination will be Bupivacaine with 50 mcg/kg of administered through caudal Morphine block after induction of anaesthesia but before the start of the surgery Intervention 50 mcg/kg of Morphine diluted This drug will be administered to a volume of 0.5 ml/kg through caudal block after induction of anaesthesia but before the start of the surgery Inclusion Criteria Inclusion Criteria Age From 3.00 Year(s) Age To 5.00 Year(s)

page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in

Gender Male Details 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 Details 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 Method of Generating Computer generated randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints 1.Postoperative Pain score will be recorded every 4 hourly surgical complications like urethrocutaneous postoperatively till 24 hours of surgery fistula or glanular dehiscence. 2.Postoperative pain assessment through FLACC Score (Face, Leg, Activity, Cry, Consolability) 3.Duration of postoperative analgesia Secondary Outcome Outcome Timepoints 1.Number of doses of rescue Recorded from end of surgery till 24 hours analgesics(paracetamol,iv morphine) used in the postoperatively postoperative period. 2.Side effects such as urinary retention, nausea and vomiting,sedation, respiratory depression and pruritus seen Target Sample Size Total Sample Size=100 Sample Size from India=100 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Post Marketing Surveillance Date of First 01/04/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details none yet Brief Summary

Hundred patients aged 3-5 yrs will be enrolled and randomly divided into two groups of 50 patients each and will be administered caudal block after induction of anaesthesia but before the start of the

page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in

surgery as follows:

Group A – 0.5 ml/kg 0.25% bupivacaine with 50mcg/kg morphine Group B – 50mcg/kg of morphine diluted to a volume of 0.5 ml/kg for blinding purpose

The duration of surgery and hospitalization time will be recorded. Postoperative surgical complications like urethrocutaneous fistula or glanular dehiscence will be documented by follow up for 2 months postoperatively on OPD basis. Postoperative pain score will be assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score every 4 hours till 24 hours post operatively. Patients with pain score ?4 will be given rescue analgesia with paracetamol at 15mg/kg or 2nd line rescue analgesia iv morphine at 100mcg/kg . The time from the caudal anesthesia to the first use of rescue analgesics and the number of doses of rescue analgesics (paracetamol, iv morphine) in the postoperative period (24 hours) will be recorded. Mean arterial pressure, heart rate, and respiratory rate will be monitored during the first 24 h of the postoperative period. Side effects such as urinary retention, nausea and vomiting, ,sedation, respiratory depression and pruritus will be also noted.

page 4 / 4