| CTRI Number |
CTRI/2024/05/067058 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Patients undergoing hip surgery will be divided into two groups and be given ultrasound guided pericapsular nerve block using levobupivacaine 0.5% or levobupivacaine 0.5% + dexamethasone to compare their effect in controlling pain. |
|
Scientific Title of Study
|
Ultrasound guided Pericapsular Nerve Group Block(PENG)For Hip Surgery: A Randomised Controlled Trial Study comparing Levobupivacaine (0.5%) and Levobupivacaine (0.5%) with Dexamethasone. |
| 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 Manpreet Raj |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical sciences ,Ranchi |
| Address |
Department of Anaesthesiology
Rajendra Institute of Medical Sciences, Bariatu, Ranchi.
Department of Anaesthesiology, RIMS, Bariatu, Ranchi.
Ranchi
JHARKHAND
834009
India |
| Phone |
6202234123 |
| Fax |
|
| Email |
rajmanpreet24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ladhu Lakra |
| Designation |
Head of department(professor) |
| Affiliation |
Rajendra Institute of Medical sciences |
| Address |
Department of Anaesthesiology
RIMS ,Bariatu ,ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9835160608 |
| Fax |
|
| Email |
dr.ladhulakra077@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Wasimul Hoda |
| Designation |
assistant professor |
| Affiliation |
Rajendra Institute of Medical sciences |
| Address |
Department of Anaesthesiology
RIMS ,Bariatu ,ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8797770602 |
| Fax |
|
| Email |
wasu077@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences, Bariyatu, Ranchi-834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Bariatu, Ranchi. |
| 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 Manpreet Raj |
Rajendra Institute of Medical Sciences, Ranchi |
1sst floor , Orthopedic surgery operation theatre, RIMS, Bariatu
Ranchi
JHARKHAND |
6202234123
rajmanpreet24@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: V299||Motorcycle rider (driver) (passenger) injured in unspecified traffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
20ml Levobupivacaine 0.5% |
local anesthetic drug used for regional blockade. |
| Comparator Agent |
20ml Levobupivacaine 0.5% along with 8mg Dexamethasone |
Dexamethasone is a corticosteroid used as an adjuvant to levobupivacaine in this study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade 1-3.
2.Patients who are older than 18 years, posted for elective surgery for hip fracture under spinal anesthesia. |
|
| ExclusionCriteria |
| Details |
1. ASA Grade 4-5
2. Patients who refuses to participate in the study.
3. History of anaphylaxis to local anesthetic agent.
4. Deranged coagulation profile.
5. Infection present at the site of block.
6. Neurological deficits like paresis or
paraplegia of the lower limb.
7. Motor power less than 5/5. |
|
|
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 |
1.Less consumption of opioids.
2.Lower NRS score pre and post block
3.Comfortable positioning for patients undergoing neuraxial blockade. |
1.NRS score pre block(baseline)
2.NRS score post block- 20 minutes
3.Hemodynamic parameters after subarachnoid blockade:
0 minutes
3 minutes
10 minutes
30 minutes
1 hour
2 hours
3 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Post op NRS scores
2. Post op Hemodynamic parameters
3. Motor blockade
4. Ambulation.
|
6 hours
12 hours
24 hours |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
18/05/2024 |
| 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 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 - NO
|
|
Brief Summary
|
The Pericapsular nerve group (PENG) block is a new regional anesthesia technique. It provides improved analgesia in patients undergoing hip surgery and preserves motor functions. It also facilitates early postoperative mobilization, decreases complication with less use of opioid during the post operative period. |