| CTRI Number |
CTRI/2023/03/050226 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation and comparison between 0.125% vs 0.25% bupivacaine for ultrasound guided sacral erector spinae block in paediatric patients undergoing hypospadias repair. |
|
Scientific Title of Study
|
Comparison of 0.125% vs 0.25% bupivacaine for ultrasound guided sacral erector spinae block in paediatric patients undergoing hypospadias repair . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Teena bansal |
| Designation |
Professor |
| Affiliation |
Pt. B.D. Sharma PGIMS ROHTAK |
| Address |
2nd floor, Department of Anaesthesiology and Critical care, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Singla |
| Designation |
Post Graduate |
| Affiliation |
Pt. B.D. Sharma PGIMS ROHTAK |
| Address |
2nd floor, Department of Anaesthesiology and Critical care, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9009369698 |
| Fax |
|
| Email |
drbhartibs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Singla |
| Designation |
Post Graduate |
| Affiliation |
Pt. B.D. Sharma PGIMS ROHTAK |
| Address |
2nd floor, Department of Anaesthesiology and Critical care, PGIMS Rohtak
HARYANA
124001
India |
| Phone |
9009369698 |
| Fax |
|
| Email |
drbhartibs@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT B.D. Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma PGIMS Rohtak |
| Address |
PGIMS, Rohtak, Haryana, 124001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bharti Singla |
Pt.B.D. Sharma PGIMS ,Rohtak |
2nd floor, Department of Anaesthesiology and Critical care, PGIMS Rohtak Haryana
Rohtak
HARYANA
Rohtak
HARYANA |
9009369698
drbhartibs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt BD Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q549||Hypospadias, unspecified, (2) ICD-10 Condition: N488||Other specified disorders of penis, (3) ICD-10 Condition: N488||Other specified disorders of penis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ultrasound guided sacral erector spinae block using 0.125% Bupivacaine in paediatric patients undergoing hypospadias repair |
Ultrasound guided sacral erector spinae plane
block in paediatric patients undergoing
hypospadias repair using 1ml/kg of 0.125% Bupivacaine once after induction of general anaestheisa |
| Intervention |
ultrasound guided sacral erector spinae block using 0.25% Bupivacaine in paediatric patients undergoing hypospadias repair |
Ultrasound guided sacral erector spinae plane block in paediatric patients undergoing hypospadias repair using 1ml/kg of 0.25% Bupivacaine once after induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Male |
| Details |
Paediatric male patients aged 8 to 12 yrs with American Society of
Anesthesiologists (ASA) physical status I or II scheduled to undergo surgery for hypospadias
repair will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Patients with
history of developmental delay,
allergic reactions to local anaesthetic
infection at the needle insertion site
bleeding disorders and on anticoagulants
parental refusal shall not be included in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time for requirement of first rescue analgesic
|
Pain assessment will be done postoperatively using VAS score at 0 hr, every 15 mins upto 1
hr, every half an hour upto 2 hours, 2 hrly upto 12 hours and then at 18th hour and 24
th hour
postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Total intraoperative fentanyl consumption
2) Post-operative pain score
3) Post-operative analgesic consumption in 24hrs
4) Complications, if any[Respiratory depression ,vomiting, others if any, shall be recorded and managed accordingly] |
Postoperative pain score using the VAS score at 0 hr, every 15 mins upto 1 hour, every half an hour upto 2 hours , 2 hourly upto 12 hours and then at 18th and 24th hour post operatively.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/03/2023 |
| Date of Study Completion (India) |
16/03/2024 |
| Date of First Enrollment (Global) |
07/03/2023 |
| Date of Study Completion (Global) |
16/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Paediatric male patients aged 8 to 12 yrs with American Society of
Anesthesiologists (ASA) physical status I or II scheduled to undergo surgery for hypospadias
repair will be included in the study. All children will be evaluated one day prior to surgery. The patients will be instructed on usage of a
10mm visual analog scale (VAS) for pain [graded from 0 ( no pain) to 10 ( most severe pain)
during preoperative evaluation .From computer generated randomization, patients will be randomly allocated to one of the two groups comprising of thirty patients. Inhalational induction of anaesthesia will be done in a standardized manner to facilitate the placement of supraglottic airway device. Group I (n=30) will be given ultrasound guided sacral erector spinae plane block
with 1 mlkg-1
of 0.125% bupivacaine.
2. Group II(n=30) will be given ultrasound guided sacral erector spinae plane block
with 1 mlkg-1
of 0.25% bupivacaine .Pain assessment will be done postoperatively using VAS score at 0 hr, every 15 mins upto 1
hr, every half an hour upto 2 hours, 2 hrly upto 12 hours and then at 18th hour and 24
th hour
postoperatively. Rescue analgesic will be given at VAS score≥ 4. Patient will be given 15mgkg-1
paracetamol
infusion over 10 min but not more frequently than 6 hours. If pain persists after paracetamol
administration, oral ibuprofen 10mgkg-1 will be given but not more frequently than 8 hrs. |