| CTRI Number |
CTRI/2024/06/069516 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| 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 of different volumes of Bupivacaine for ultrasound guided sacral erector spinae block in pediatric patients undergoing hypospadias repair |
|
Scientific Title of Study
|
Comparison of different volumes of Bupivacaine for ultrasound guided sacral erector spinae block in pediatric patients undergoing hypospadias repair. |
| Trial Acronym |
NIL |
|
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 |
| Address |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak, Haryana, India
Rohtak
HARYANA
124001
India |
| Phone |
9034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Teena Bansal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS |
| Address |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak, Haryana, India
Rohtak
HARYANA
124001
India |
| Phone |
9034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Teena Bansal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS |
| Address |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak, Haryana, India
Rohtak
HARYANA
124001
India |
| Phone |
9034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical care
Pt B D Sharma PGIMS Rohtak
Haryana 124001, India |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak, Haryana, India |
| 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 Arunkumar T |
Pt B D Sharma PGIMS Rohtak |
Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak, Haryana, India
Rohtak
HARYANA |
9047030769
arunthana1926@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIO MEDICAL 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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided sacral erector spinae block using 0.75ml/kg of 0.25% bupivacaine in pediatric patients undergoing hypospadias repair |
Ultrasound guided sacral erector spinae block in pediatric patients undergoing hypospadias repair at the end of surgery before extubation using local anaesthetic in a dose of 0.75ml/kg of 0.25% bupivacaine will be given |
| Intervention |
Ultrasound guided sacral erector spinae block with 1ml/kg of 0.25% bupivacaine |
Ultrasound guided sacral erector spinae block in pediatric patients undergoing hypospadias repair at the end of surgery before extubation using local anaesthetic in a dose of 1ml/kg 0.25% bupivacaine will be given |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Male |
| Details |
Pediatric patients aged 8-12 years of age with ASA grade I and II scheduled for hypospadias repair |
|
| ExclusionCriteria |
| Details |
Patients with
1: weight more than 25 kg
2: history of developmental delay,
3: allergic reactions to any local anaesthetic,
4: infection at puncture site,
5: anatomical deformity at local site,
6: bleeding disorders or on anticoagulants
7: parental refusal |
|
|
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 |
| Number of blocked dermatomes |
Number of blocked dermatomes will be assessed at 30 mins, 45 mins, 60 mins using pin prick method |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Postoperative pain score using Visual analogue score (VAS) Scale
2) Postoperative analgesic consumption in 24hrs
3) Time to first rescue analgesia
4) ComplicationS if any [Respiratory distression, vomiting, others if any shall be recorded & managed accordingly]
|
postoperatively blocked dermatomes assessed at 30 min, 45 min & 60 min
VAS score at 0 h, every 15 min upto 1 h, every half an hour upto 2 h, 2 hrly upto 12 h, then at 18th h & 24 th h
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 pin prick method for dermatomal spread and 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 0.25% bupivacaine. Group II(n=30) will be given ultrasound guided sacral erector spinae plane block with 0.75 mlkg-1 of
0.25% bupivacaine . Number of blocked dermatomes will be assessed at 30 mins, 45 mins, 60 mins using pin prick method. 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 hours. |