| CTRI Number |
CTRI/2026/01/100042 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief Study Using Two Different bupivacaine Doses Before Spinal Anaesthesia in Hip Fracture Patients |
|
Scientific Title of Study
|
A Randomized Comparative Study Of two dose 20ml and 15ml of 0.25 percent bupivacaine in pericapsular nerve group block on ease of patient positioning for subaracnoid block in hip fracture surgery in Department of Anaesthesia SMS Medical college Jaipur |
| 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 Priyanka jain |
| Designation |
Professor |
| Affiliation |
Sms medical college and attached hospital |
| Address |
Department of anaesthesia Sawai man singh medical college and attached hospitals jaipur rajasthan India 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9309482150 |
| Fax |
|
| Email |
Priyanka.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka jain |
| Designation |
Professor |
| Affiliation |
Sms medical college and attached hospital |
| Address |
Department of anaesthesia Sawai man singh medical college and attached hospitals jaipur rajasthan India 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9309482150 |
| Fax |
|
| Email |
Priyanka.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Baroria |
| Designation |
Junior resident |
| Affiliation |
Sms medical college and attached hospital |
| Address |
Department of anaesthesia Sawai man singh medical college and attached hospitals jaipur rajasthan India 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
302004 |
| Fax |
|
| Email |
baroriajitendra16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia sms medical College jaipur Rajasthan 302004 india |
|
|
Primary Sponsor
|
| Name |
Sms medical college jaipur |
| Address |
Department of anaesthesiology sms medical college jaipur 302004 India |
| 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 Priyanka jain |
sms medical college |
2nd floor ot number 1 trauma operation theatre department of anaesthesia sms medical college jaipur 302004 India
Jaipur
RAJASTHAN |
9309482150
Priyanka.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethicscommitee sms medical college and attached hospitals jaipur |
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 |
15 mL of 0.25 percent bupivacaine in PENG block for patient positioning in SAB |
15 mL of 0.25 percent bupivacaine in PENG block for patient positioning in SAB In hip fracture surgery |
| Comparator Agent |
20 mL of 0.25 percent bupivacaine in PENG block for patient positioning in SAB |
20 mL of 0.25 percent bupivacaine in PENG block for patient positioning in SAB In hip fracture surgery |
| Intervention |
Study of two doses of bupivacaine in PENG block for patient positioning for subarachnoid block |
A Randomized Comparative Study Of two dose 20ml and 15ml of 0.25 percent bupivacaine in pericapsular nerve group block for patient positioning for subaracnoid block in hip fracture surgery . |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery for hip fracture
Patients consenting to participate
Patient belonging to ASA grade 1, 2, 3
Adult patients age 30 to 70 years |
|
| ExclusionCriteria |
| Details |
Patients with psychiatric illness, anxious, agitated.
Patients with peripheral sensorineural deficit.
Patients allergic to local anesthetics.
Patients with contraindications to regional anaesthesia.
Patients with suspected compartment syndrome in lower limbs.
Patients on analgesia within 8 hours before performing nerve block.
Block failure cases If VRS score is not less than 3 within 20 min of performing peripheral nerve blocks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Measure the EOP of patients with hip fractures to conduct SAB |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measure the pain assessment at the rest and 15 degree leg raise positions before the
block (T0),at 10 minutes (T10) and 20 minutes (T20) after the block. |
0,10,20 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/01/2026 |
| 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="2"
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
|
In this study we will Comparae two dose 20ml and 15ml of 0.25 percent bupivacaine in pericapsular nerve group block for patient positioning for subaracnoid block in hip fracture surgery |