| CTRI Number |
CTRI/2025/06/089644 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of analgesic method in children undergoing penile surgery |
|
Scientific Title of Study
|
Comparison of ultrasound-guided sacral multifidus plane block versus caudal epidural block (CEB) for analgesia in children undergoing penile surgery: a randomized controlled study. |
| 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 Alok Kumar Sahoo |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room no 8, Department of Anesthesiology, Hospital Buliding, AIIMS, BBSR
Khordha
ORISSA
751019
India |
| Phone |
9438884160 |
| Fax |
|
| Email |
alokks108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Kumar Sahoo |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Dept of Anesthesiology, Room no 8, Hospital Buliding, AIIMS, BBSR
Khordha
ORISSA
751019
India |
| Phone |
9438884160 |
| Fax |
|
| Email |
alokks108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok Kumar Sahoo |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Det of Anesthesiology, Room no 8, Hospital Buliding, AIIMS, BBSR
Khordha
ORISSA
751019
India |
| Phone |
9438884160 |
| Fax |
|
| Email |
alokks108@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, Bhubaneswar |
| Address |
AIIMS, Sijua, Bhubaneswar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Alok Kumar Sahoo |
AIIMS, Bhubaneswar |
Department of Anesthesiology, AIIMS, Bhubaneswar
Khordha
ORISSA |
09438884160
alokks108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N489||Disorder of penis, unspecified, (2) ICD-10 Condition: N51||Disorders of male genital organs in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal epidural block (CEB) with 0.25% Ropivacaine |
Caudal epidural block after negative aspiration, 0.25% ropivacaine, will be injected in the canal at a dose of 0.5 -1 ml/kg, maximum 20 ml. |
| Intervention |
sacral multifidus plane block with ropivacain 0.25% |
SMPB s will be performed at the S1 retrolaminar area level with ultrasonography (USG).Local anesthetic will be injected between the intermediate sacral crest and overlying multifidus muscle. 0.25% ropivacaine, maximum dose 2-3mg/kg, in total volume of 1 ml/ kg divided in both sides will be used for surgical anaesthesia blocks |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Male |
| Details |
1. ASA grade I and II patients
2. Male children aged between 3-12 years of age scheduled for hypospadias repair.
|
|
| ExclusionCriteria |
| Details |
1. Children with a bleeding disorder
2. Redo urethroplasty
3. Contraindication to CEB
4. Vertebral column anomaly
5. Neurological disorders
6. Refusal of the parents for regional blocks
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify, the time to first rescue analgesia measured from the end to surgery till first dose of analgesics administrated in paediatric patient measured with Modified Objective Pain Scale (MOPS). The adequate pain control is defined as MOPS score less than or equal to 4 after surgery |
the time to first rescue analgesia measured from the end to surgery till first dose of analgesics |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Intraoperative haemodynamic parameters (heart rate, MAP) between groups.
• Modified Objective Pain Scale (MOPS) on arrival in post anaesthesia care unit at 1, 2, and 6 hours after surgery.
• Total intraoperative fentanyl consumption
• The total dose analgesics required in the first 24 hours of surgery.
• Surgeon satisfaction score concerning operating conditions will be recorded at the end of surgery on 5-point scoring system.
|
from end of surgery till 24hr |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [alokks108@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The sacral multifidus plane (SMPB) block is a regional
block that targets both the dorsal and ventral roots of the spinal nerve,
offering analgesia for both somatic and visceral pain. This technique
facilitates the extensive distribution of local anaesthetics in a craniocaudal
direction, effectively blocking multiple dermatomes From S1-S4. [4] Recently,
some case reports suggested that the sacral multifidus plane block, was found
to be an effective technique for providing postoperative pain relief in
patients undergoing hypospadias surgery.
Hence, we hypothesize
that the sacral multifidus plane block may provide equivalent analgesia
compared to CEB in penile surgery. |