| CTRI Number |
CTRI/2021/04/032822 [Registered on: 15/04/2021] Trial Registered Prospectively |
| Last Modified On: |
13/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief in the patients of fractured hip surgeries |
|
Scientific Title of Study
|
Comparison of ultrasound-guided pericapsular nerve group block(PENG Block) and PENG Block with lateral femoral cutaneous nerve block (LFCN) for the fractured hip surgeries-a prospective double blinded randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief Medical Superintendent |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anesthesia and Pain relief Service, OT complex, First floor,
Tata Motors Hospital, Jamshedpur
Karangajhar, Telco colony,
Jamshedpur
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
06576695676 |
| Fax |
|
| Email |
jadona@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief Medical Superintendent |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anesthesia and Pain relief Service, OT complex, First floor,
Tata Motors Hospital, Jamshedpur
Karangajhar, Telco colony,
Jamshedpur
JHARKHAND
831004
India |
| Phone |
06576695676 |
| Fax |
|
| Email |
jadona@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief Medical Superintendent |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anesthesia and Pain relief Service, OT complex, First floor,
Tata Motors Hospital, Jamshedpur
Karangajhar, Telco colony,
Jamshedpur
JHARKHAND
831004
India |
| Phone |
06576695676 |
| Fax |
|
| Email |
jadona@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Motors Hospital, Telco Colony, Kharangajhar, Jamshedpur-831004 |
|
|
Primary Sponsor
|
| Name |
Dr Ashok Jadon |
| Address |
Dept. of Anesthesia & Pain Relief Service, Tata Motors Hospital, Jamshedpur |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Motors Hospital |
Dept. of Anesthesia & Pain Relief Service, Tata Motors Hospital, Kharangajhar,Jamshedpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Jadon |
Tata Motors Hospital |
Department of Anesthesia, Tata Motors Hospital
Telco Colony, Kharangajhar
Purbi Singhbhum
JHARKHAND |
06576695676
jadona@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Tata Motors Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PENG and Lateral Femoral Cutaneous Nerve (LFCN) block |
Total 30 ml solution of 0.5% ropivacaine and 8mg dexamethasone will be prepared. After localisation of PENG anatomy under low frequency ultrasound probe (2-5 MHz), 25 ml solution from the prepared mixture will be injected and remaining 5 ml solution will be used to block the LFCN. |
| Intervention |
Ultrasound guided pericapsular nerve group (PENG) block |
After localisation of PENG anatomy under low frequency ultrasound probe (2-5 MHz), 30 ml 0.5% bupivacaine and 8 mg dexamethasone will be injected by in-plane technique. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with fractured hip with moderate to severe pain and unable to sit due to pain and given consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Contraindication to regional anaesthesia like bleeding disorder, infection at the site of injection, allergic to local anaesthetic.
2. Severe cardio-respiratory disease.
3. Uncooperative and unable to understand and communicate regarding pain score.
4. Violation of protocol.
5. Refusal to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Decrease in rest pain and pain on passive 15 degree lift of fractured limb.
2. Ease of spinal positioning |
Pre-block,and post-block 30min,2h,4h,6h,8h,12h & 24h |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Visual analogue score.
2. Tramadol requirement.
3. PONV
4. Block related side effects |
1.Zero hr (at the time of block).
2.every 5 minutes till 30 minutes.
3. 2h,4h,6h,8,12h,24h postoperative. |
|
|
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)
|
16/04/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with fractured hip are unable to position for spinal anesthesia due to severe pain. Pericapsular nerve group (PENG) block provide effective analgesia for spinal positioning. Studies have suggested that combining lateral femoral cutaneous nerve (LFCN) block may increase the analgesic potential of PENG block. We will be conducting this study to analyse the analgesic benefits in term of reduction in pain after block, improvement in ease of spinal positioning, better VAS score and reduction in rescue analgesic (injection Tramadol). |