| CTRI Number |
CTRI/2025/04/085756 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| 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 two different regional block techniques for analgesic efficacy in pediatric patients undergoing open hip surgeries |
|
Scientific Title of Study
|
Ultrasound-guided caudal epidural Versus PENG Block as a part of the opioid-sparing multimodal analgesic regime for pediatric open hip surgery: A comparative prospective Randomized Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Rao Maremanda |
| Designation |
Assistant Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India.
Hyderabad
TELANGANA
500082
India |
| Phone |
8790615789 |
| Fax |
|
| Email |
maremanda.krishnarao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Rao Maremanda |
| Designation |
Assistant Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India.
TELANGANA
500082
India |
| Phone |
8790615789 |
| Fax |
|
| Email |
maremanda.krishnarao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Rao Maremanda |
| Designation |
Assistant Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India.
TELANGANA
500082
India |
| Phone |
8790615789 |
| Fax |
|
| Email |
maremanda.krishnarao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India-500082 |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India-500082 |
| 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 Krishna Rao Maremanda |
Nizams Institute of Medical Sciences |
Department of Anesthesiology, Old Block, Orthopaedics Operation Theatre, Nizams Institute of Medical Sciences.
Hyderabad
TELANGANA |
8790615789
maremanda.krishnarao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nizams Institutional Ethics Committee |
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 |
nil |
nil |
| Intervention |
Ultrasound guided PENG Block Group |
In Group PENG, the patient will be positioned in a supine position. The anatomical landmarks, including IPE, the iliopsoas muscle and tendon, the femoral artery and vein, and the pectineus muscle, will be identified using a 9–12 MHz superficial linear transducer. After skin preparation, the needle’s tip will be positioned at the musculofascial plane between the ilio-pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration to avoid intravascular injection, 0.5–1 ml of normal saline will be injected to confirm the correct needle site. A 0.5 ml/kg plain ropivacaine 0.2%, a maximum dose of 2 mg/kg ropivacaine will be injected. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status class I–II and scheduled for elective unilateral hip surgery due to hip avascular necrosis, dislocation, dysplasia or fracture. |
|
| ExclusionCriteria |
| Details |
Children diagnosed with neurological, spinal, or coagulation disorders, infections suspected or confirmed to be related to block sites, histories of allergies to local anesthetics (LAs), bilateral or redo hip surgeries, and parents who refused to participate in the study will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the postoperative pain scores in the first 24 hours after surgery in patients undergoing hip surgery receiving either PENG or caudal epidural block. |
intraoperatively after administration of the block and at 30,60,90,120min,6,12 and 24hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time to first request opioid analgesics, total opioid consumption in 24 hours, adverse effects, and parents’ satisfaction. |
intraoperatively after administration of the block and at 30,60,90,120min,6,12 and 24hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [maremanda.krishnarao@gmail.com].
- For how long will this data be available start date provided 30-04-2025 and end date provided 11-04-2025?
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
|
Management of postoperative pain after open hip joint surgery in the pediatric population is often challenging, necessitating the use of systemic opioids. [1] Globally, opioid-sparing strategies and enhanced recovery after surgery programs are making their appearance in pediatric surgical specialties. [2] Regional anesthesia and a robust plan for multimodal analgesia are the primary methods being used to decrease opioid use. [3, 4] The most frequently used method of regional analgesia in pediatric hip surgery is caudal epidural blocks. [5] However, it is known to be associated with numerous adverse effects like bilateral motor blockade, hypotension, and accidental dural puncture. [6] Regional blocks such as Pericapsullar nerve group (PENG) block in adjuvant with general anesthesia is an alternative perioperative analgesic technique and have been reported in many case series to cause unilateral sensory blockade with an excellent safety profile in pediatric surgical patients.[7] The Pericapsullar nerve group (PENG) block is a novel motor-sparing regional anesthetic technique where the local anesthetic agent is deposited in the musculofascial plane between the psoas tendon and the pubic ramus. The main target is the genicular branches of the femoral, obturator, and accessory obturator nerve, which innervate the hip capsule. [8] However, pediatric peripheral RA lags behind adult practice in the type of RA offered and the percentage of cases performed with a regional technique among eligible patients. No prospective randomized trials compare the analgesic efficacy of PENG block with the traditional caudal epidural block in pediatric patients. This study is carried out to assess ultrasound-guided PENG block versus caudal block for its analgesic efficacy, opioid-sparing effects, and safety in pediatric hip surgery. The primary objective is to evaluate the postoperative pain scores in the first 24 hours after surgery in patients undergoing hip surgery receiving either PENG or caudal epidural block. The secondary objectives include time to first request opioid analgesics, total opioid consumption in 24 hours, adverse effects, and parents’ satisfaction. We hypothesize that the PENG blocks could offer superior perioperative analgesia compared to caudal epidural for hip surgery in children. |