| CTRI Number |
CTRI/2024/09/074207 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two ultrasound guided nerve block techniques for pain relief after childrens hip surgery. |
|
Scientific Title of Study
|
Comparative evaluation between ultrasound guided supra-inguinal fascial iliaca blocks
with pericapsular nerve group block (SIFI with PENG) and ultrasound guided
quadratus lumborum block with pericapsular nerve group block (QL with PENG) for
postoperative analgesia in children requiring a hip surgery. A Randomized Controlled
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 |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabiliation |
| Address |
operation theatre complex, Second floor, Department of Anesthesiology,Sancheti Institute for Orthopedics and Rehabiliation, 16, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabiliation |
| Address |
operation theatre complex, Second floor, Department of Anesthesiology,Sancheti Institute for Orthopedics and Rehabiliation, 16, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabiliation |
| Address |
operation theatre complex, Second floor, Department of Anesthesiology,Sancheti Institute for Orthopedics and Rehabiliation, 16, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Hospital 11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Sancheti Hospital |
| Address |
Sancheti Hospital 11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra,India |
| 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 Sandeep Diwan |
Sancheti Institute of Orthopedics and Rehabilitation |
Operation Theatre complex, Department of Anesthesiology, Sancheti Institute of Orthopedics and Rehabilitation,16 Shivajinagar, Pune-411005
Pune
MAHARASHTRA |
8484914584
sdiwan1965@gmx.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sancheti Institute of Orthopedics and Rehabilitation |
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 |
| Intervention |
Group-1 Ultrasound-guided Supra-Inguinal Fascial Iliaca (SIFI) Block with Pericapsular Nerve Group (PENG) Block
Ultrasound-guided Quadratus Lumborum (QL) Block with Pericapsular Nerve Group (PENG) Block
|
SIFI block with 10 ml of local anesthetic (LA) will be given once before procedure |
| Comparator Agent |
Group-2 Ultrasound-guided Quadratus Lumborum (QL) Block with Pericapsular Nerve Group (PENG) Block |
QL block with 10 ml of local anesthetic (LA) will be given once before procedure |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Adults of either gender aged between age between 1-7 years with American Society of
Anesthesiologists (ASA) physical status I to III undergoing hip surgery |
|
| ExclusionCriteria |
| Details |
1. Patients with coagulopathy, sepsis, hepatic or renal failure. 2. allergy to local anesthetic (LA) 3.Patients having opioids previously. 4. Refusal of parental consent 5. Refusal of parental consent 6. Patients with pre-existing neuropathies 7. Patients with local infection around the needle site |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The times of rescue analgesia and the adverse reactions caused by the analgesics such
as pruritus, nausea and vomiting
|
first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The FLACC scale will be used to assess the pain
2.The satisfaction of surgeon & of patients the satisfaction
3.Total fentanyl consumption in 24 hours |
FLACC scale will aseess pain at 0.5, 1, 2, 4, 8, 12, & 24 h hour after operation. 4. Total fentanyl consumption will be assessed at 24 hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/10/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Pain management following surgical procedures is essential in paediatric patients. Adequate analgesia is vital in their recovery and overall experience within the healthcare system. Adequate pain management following surgery is also linked to increased patient satisfaction, earlier mobilization, decreased pain medication requirements, and improved outcomes. We aim to alleviate pain while minimizing the potential for adverse effects has led to the exploration of regional anaesthesia techniques as a viable alternative to systemic opioids-based analgesics. Previous meta-analysis in adults has shown that peripheral nerve blocks reduce pain during movement and decrease the time to mobilisation in adult patients undergoing hip surgery.This study is planed to explore optimal pain management strategy in pediatric patients by exploring and evaluating the SIFI and QL block techniques with respect to duration of analgesia ( primary objective), 24-hour opioid consumption, motor impairment, potential adverse effects, and overall patient satisfaction associated with these techniques in children undergoing hip surgery.
|