| CTRI Number |
CTRI/2024/03/064946 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between two different nerve blocks given around the hip joint for relieving pain during positioning of patients with hip fractures for regional anesthesia. |
|
Scientific Title of Study
|
A comparative study between Pericapsular nerve group block and Suprainguinal fascia iliaca compartment block for positioning patients with hip fractures before regional anesthesia. |
| 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 JYOTHI B |
| Designation |
Assisstant Professor |
| Affiliation |
CDSIMER |
| Address |
Department of Anesthesiology ,
CDSIMER,
Harohalli, Ramnagara
Department of Anesthesiology ,
CDSIMER,
Harohalli, Ramnagara
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
9686144411 |
| Fax |
|
| Email |
gnanjyothi16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JYOTHI B |
| Designation |
Assisstant Professor |
| Affiliation |
CDSIMER |
| Address |
Department of Anesthesiology ,
CDSIMER, Harohalli, Ramnagara
CDSIMER,
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
9686144411 |
| Fax |
|
| Email |
gnanjyothi16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JYOTHI B |
| Designation |
Assisstant Professor |
| Affiliation |
CDSIMER |
| Address |
Department of Anesthesiology ,
CDSIMER, Harohalli, Ramnagara
CDSIMER,
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
9686144411 |
| Fax |
|
| Email |
gnanjyothi16@gmail.com |
|
|
Source of Monetary or Material Support
|
| CDSIMER, Harohalli, Ramnagara, Bangalore rural, INDIA - 562112 |
|
|
Primary Sponsor
|
| Name |
CDSIMER |
| Address |
Harohalli, Ramnagara, Bangalore rural - 562112 |
| Type of Sponsor |
Private 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 |
| Jyothi B |
CDSIMER |
Department of Anesthesiology,, Harohalli, Ramnagara, Bangalore rural-562112
Bangalore Rural
KARNATAKA |
9686144411
gnanjyothi16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- CDSIMER |
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 |
Pericapsular neve group block |
PENG block is given with Inj Lignocaine adrenaline 1%, 20ml in the proximity of Pericapsular nerve group under ultrasound guidance. |
| Intervention |
Suprainguinal fascia iliac compartment block |
SIFI block is given with Inj Lignocaine adrenaline 1%, and 30 ml is given in the Suprainguinal fasia Iliaca plane under ultrasound guidance. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with hip fracture posted for corrective surgeries. |
|
| ExclusionCriteria |
| Details |
Contraindication for regional anesthesia. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical rating scale score1-10 |
Interval of 10 minutes upto 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of positioning on a scale of 0-3.
Additional analgesic used at the end of 30 minutes. |
At the end of 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
10/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/10/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - NO
|
|
Brief Summary
|
With the increasing average life span of humans, the incidence of hip fractures commonly associated with the elderly population with associated co-morbidities has increased. Novel corrective surgeries have enabled us to help patients to achieve a near-normal functional life. The majority of hip surgeries are done under regional anesthesia as it is a safer anesthetic technique for elderly patients. These patients have to be sitting up during an anesthesia procedure which can be extremely painful. Many drugs and regional techniques have been used to reduce this positioning pain before anesthesia. Pericapsular nerve group block or PENG block and Suprainguinal facia iliaca compartment block or SIFI block under ultrasound guidance have been successfully used for postoperative analgesia, and only a few studies have been done to evaluate their preoperative uses with short-acting drugs. We have designed this study to compare the effectiveness of PENG and SIFI block in providing pain relief to patients with hip fractures during positioning for the planned regional anesthetic procedure. |