| CTRI Number |
CTRI/2024/09/073855 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the benefits of Pericapsular Nerve Block for making easier to position for Spinal Anesthesia in Hip Fracture Surgeries : An Observational study |
|
Scientific Title of Study
|
Evaluation of Pericapsular Nerve Group (PENG) Block
For Ease of Spinal Positioning (EOSP) During Sub
Arachnoid Blockade in Hip Fracture Surgeries: A
Prospective, Observational 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 |
Dr Nallapothula Udayini |
| Designation |
Post Graduate |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Anaesthesiology Yenepoya Medical College Yenepoya (Deemed to be) University Derlakatte Mangalore Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9177036188 |
| Fax |
|
| Email |
nallapothulaudayini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Prasad |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Anesthesiology Yenepoya Medical College Yenepoya (Deemed to be) University Derlakatte Mangalore Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844774108 |
| Fax |
|
| Email |
hidrkp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Prasad |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Anesthesiology Yenepoya Medical College Yenepoya (Deemed to be) University Derlakatte Mangalore Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844774108 |
| Fax |
|
| Email |
hidrkp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Yenepoya Medical College and Hospital |
| Address |
Yenepoya Medical College Hospital Yenepoya ( Deemed to be) University Derlakatte Mangalore 575018 Karnataka India |
| 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 |
| Dr Nallapothula Udayini |
Yenepoya Medical College and Hospital |
Patient Holding Area and Operation Theatre
Department of Anaesthesiology Yenepoya Medical College and Hospital, Mangalore
Dakshina Kannada
575018
Karnataka
India
Dakshina Kannada
KARNATAKA |
9177036188
nallapothulaudayini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YENEPOYA ETHICS COMMITTEE-1 |
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 |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 TO 80 years
Patients belonging to American Society of Anesthesiologists ASA I TO III
Inter trochanteric hip fractures
Fracture neck of femur
Total hip arthroplasty procedures
|
|
| ExclusionCriteria |
| Details |
Coagulopathies
Allergy to planned drugs
Impaired cognition or dementia
Shaft of femur fractures
Local infection at the injection site
Any previous analgesic administration during the last 6 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate Pericapsular Nerve Group (PENG) block for ease of spinal positioning (EOSP) during sub arachnoid blockade in hip fracture surgeries
To measure patients Visual Analogue Scale (VAS) score and 15-degree passive Straight leg raise (SLR) VAS at rest, at 15 min and at 30 min after the PENG block
|
At rest
At 15 minutes and at 30 minutes after Pericapsular Nerve Group Block(PENG)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure the hemodynamics [Heart rate (HR) & Mean Arterial (Blood Pressure (MAP)] at rest
at 15 min & at 30 min after PENG block
To evaluate the Ease Of Spinal Positioning (EOSP) grade during subarachnoid block
|
At rest
At 15 minutes & at 30 minutes after Pericapsular Nerve Group Block(PENG) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/09/2024 |
| 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
|
Hip fractures (inter trochanteric hip fractures, fracture neck of femur, total hip arthroplasty procedures) are some of the commonest fractures, especially in the elderly population. Spinal anaesthesia has been favored by most anaesthesiologists for hip fracture surgeries. Severe pain experienced during positioning for spinal anaesthesia can worsen the patient experience and complicate the technique of spinal anaesthesia. PENG block targets the articular branches of femoral nerve (FN), accessory obturator nerve (AON) and obturator nerve (ON) in providing analgesia for hip fractures. It is based on blocking articular branches to the hip joint, mostly anterior capsule of hip joint, using ultrasound guided injection of local anaesthetics and is utilized for ease of positioning patient perioperatively for administration of sub arachnoid block. |