| CTRI Number |
CTRI/2024/12/078728 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of addition of an adjunct to local anesthetic versus local anesthetic alone in ultrasound guided nerve group block for proximal lower limb fractures near the hip joint. |
|
Scientific Title of Study
|
Dexmedetomidine and Bupivacaine versus Bupivacaine Alone in Ultrasound Guided PENG block in proximal Femoral Fractures: a Randomized Comparative 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 |
Ruchi Singh |
| Designation |
Assistant Professor |
| Affiliation |
Government institute of medical sciences |
| Address |
First floor OT complex,GIMS
Gautam Buddha Nagar
UTTAR PRADESH
201307
India |
| Phone |
9165291956 |
| Fax |
|
| Email |
Instantruchi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ruchi Singh |
| Designation |
Assistant professor |
| Affiliation |
Government institute of medical sciences |
| Address |
First floor,ot complex
Gautam Buddha Nagar
UTTAR PRADESH
201307
India |
| Phone |
9165291956 |
| Fax |
|
| Email |
Instantruchi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi singh |
| Designation |
Assistant orofessor |
| Affiliation |
Government institute of medical sciences |
| Address |
First floor,ot complex
Gautam Buddha Nagar
UTTAR PRADESH
201307
India |
| Phone |
9165291956 |
| Fax |
|
| Email |
Instantruchi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences, Greater Noida, Gautam Buddha Nagar, Uttar pradesh. 201307 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences |
| Address |
Government Institute of Medical Sciences ,Greater Noida, Gautam Buddha Nagar, Uttar Pradesh. 201307 |
| 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 Ruchi Singh |
Government institute of medical science,greater noida |
First floor,orthopedics ot,OT complex
Gautam Buddha Nagar
UTTAR PRADESH |
9165291956
instantruchi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine alone |
patients will receive (0.5ml) normal saline in PENG block with 20 ml of 0.25% bupivacaine, before giving spinal anesthesia
|
| Intervention |
Dexmedetomidine and Bupivacaine Combination |
patients will receive 50mcg (0.5ml) dexmedetomidine in PENG block with 20 ml of .25% bupivacaine, before giving spinal anesthesia
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
criteria:ASA 1,2,3 patients of 18 to 60 years of
age with only proximal femur fractures (neck of femur,
intertrochanteric, and subtrochanteric fractures) undergoing
surgery under spinal anaesthesia, having significant pain
visual analogue scale (VAS) ≥4 and expected surgery duration
of less than 150 min |
|
| ExclusionCriteria |
| Details |
Patients with old fractures (more than 7 days),
polytrauma, bleeding disorders or coagulopathy, local site infection,
difficulty expressing pain scores such as hearing disability, mentally
challenged, dementia or psychiatric illness,patients on chronic opioids
or drug addicts. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
FIRST 24HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of spinal position score (EOSP) |
30 minutes after the block |
| Postoperative pain scores |
at .5h,2h, 4h,6h,12h,24h |
| Quadriceps weakness |
At 6 hours postoperatively |
| Total number of rescue analgesics in first 24 hours |
24 hours |
| Postoperative inflammatory stress response |
Preoperative,1 hour postoperatively |
| Side effects ,if any |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/01/2025 |
| Date of Study Completion (India) |
25/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 - Informed Consent Form
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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Instantruchi@gmail.com ].
- For how long will this data be available start date provided 18-12-2024 and end date provided 18-12-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Anaesthetists have sought strategies to extend the benefits of single-shot peripheral nerve blocks beyond the duration of commonly available local anaesthetics (LA).Dexmedetomidine, an alpha-2 agonist, has been proposed as a safe and effective adjunct capable of extending the duration of single-shot block.Hyperpolarization-activated cation currents normally bring neurons back to the resting potential and normal functional activity during the refractory phase in an action potential. By blocking these currents, dexmedetomidine can accentuate inhibition of neuronal conduction and produce analgesia. Severe pain is associated with proximal femur fracture .Use of regional anesthesia (RA) has been associated with reduced opioid consumption in postoperative period, thereby enabling early mobilization and fewer opioid related side effects.Some case series and randomized control studies suggest PENG block as an effective alternative to femoral nerve block and fascia iliaca block for femur fracture pain relief. However, there is no RCT comparing the analgesic effect of Dexmedetomidine and Bupivacaine compared to Bupivacaine alone in the PENG block |