| CTRI Number |
CTRI/2025/09/095440 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between Intrathecal Isobaric Bupivacaine Hydrochloride Versus Hyperbaric Bupivacaine Hydrochloride |
|
Scientific Title of Study
|
Comparison Between Intrathecal 0.5 Percent Isobaric Bupivacaine Hydrochloride Versus 0.5 Percent Hyperbaric Bupivacaine Hydrochloride With Fentanyl As An Adjuvant In Both For Proximal Femur Nailing Surgery A Prospective Randomized Double Blind Controlled 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 Monish Kumar |
| Designation |
Resident Anesthesiology |
| Affiliation |
Pacific Medical College Hospital |
| Address |
Department Of Anesthesiology And Critical Care Third Floor Pacific Medical College Hospital Bilo Ka Bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9884404849 |
| Fax |
|
| Email |
dr.monishkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Sharma |
| Designation |
Associate Professor |
| Affiliation |
Pacific Medical College Hospital |
| Address |
Department Of Anesthesiology And Critical Care Third Floor Pacific Medical College Hospital Bilo Ka Bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9372985559 |
| Fax |
|
| Email |
28ganesha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Sharma |
| Designation |
Associate Professor |
| Affiliation |
Pacific Medical College Hospital |
| Address |
Department Of Anesthesiology And Critical Care Third Floor Pacific Medical College Hospital Bilo Ka Bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9372985559 |
| Fax |
|
| Email |
28ganesha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anesthesiology And Critical Care Third Floor Pacific Medical College Hospital Bilo Ka Bedla Udaipur Rajasthan 313001 |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College Hospital |
| Address |
Department Of Anesthesiology And Critical Care Third Floor Pacific Medical College Hospital Bilo Ka Bedla Udaipur Rajasthan 313001 |
| 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 Monish Kumar |
Pacific Medical College Hospital |
Department Of Anesthesiology And Critical Care Third Floor Pacific Medical College Hospital Bilo Ka Bedla Udaipur Rajasthan 313001
Udaipur
RAJASTHAN |
9884404849
dr.monishkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Pacific Medical College And Hospital Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S721||Pertrochanteric fracture, (2) ICD-10 Condition: S722||Subtrochanteric fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Bupivacaine 0.5 Percent With Fentanyl |
Single Injection Spinal Anaesthesia Of 0.5 Percent Hyperbaric Bupivacaine 2.5ml 12.5mg With 0.5ml 25mcg Fentanyl Total Volume 3 ml given Once Before Surgery Intrathecally At Subarachnoid Space
Duration of Intervention
From Time Of Spinal Injection Until Regression Of Sensory And Motor Block 90 to 150 Minutes |
| Intervention |
Isobaric Bupivacaine 0.5 Percent With Fentanyl |
Single Injection Spinal Anaesthesia Of 0.5 Percent Isobaric Bupivacaine 2.5ml 12.5mg With 0.5ml 25mcg Fentanyl Total Volume 3 ml given Once Before Surgery Intrathecally At Subarachnoid Space
Duration of Intervention
From Time Of Spinal Injection Until Regression Of Sensory And Motor Block 90 to 180 Minutes |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age group between 50 and 70 years of either sex
Patient belonging to American Society of Anesthesiologists ASA grade I and II
Patients posted for Proximal Femoral Nailing surgery
Patients who required elective surgery only
|
|
| ExclusionCriteria |
| Details |
Patient refusal for the procedure and technical difficulties
Age less than 50 and more than 70 years
ASA Grade More Than III
Patients with known hypersensitivity to Bupivacaine Fentanyl
Mental retardation congenital anomaly patients
Those with bleeding disorders and local sepsis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will compare the efficacy of both hyperbaric and isobaric preparations of bupivacaine and if possible to replace hyperbaric bupivacaine with fentanyl with isobaric bupivacaine with fentanyl specially in elderly patients due to its superior hemodynamic stability postoperative analgesia and recovery |
Onset of sensory and motor block
Duration of sensory and motor block Hemodynamic changes at 0,5,10,15,20,25,30,60,90 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy of postoperative analgesia
Side effects (Bradycardia, Respiratory Depression, hypotension, nausea & vomiting, shivering)
|
Efficacy Of Postoperative Analgesia Was Assessed At 30 Minutes, 1, 2, 4, And 8 Hours Along With The Need For Rescue Analgesia.
Side Effects Such As Bradycardia, Respiratory Depression, Hypotension, Nausea And Vomiting, And Shivering Were Observed And Recorded For 24 Hours. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 primary aim of this study is to compare the efficacy of intrathecal hyperbaric bupivacaine hydrochloride 2.5 ml with fentanyl 25mcg versus intrathecal isobaric bupivacaine hydrochloride 2.5 ml with fentanyl 25mcg for proximal femur nailing surgery A double blind randomized controlled clinical study will be conducted on 70 patients admitted at Pacific Medical college Udaipur, over the period of two years. After obtaining the approval from the ethical committee of the institution, this study will be conducted. Informed written consent would be taken from patient and his/her relatives.
Patients will be randomly divided into two groups using the closed envelope method. The study will include all patients aged between 50 and 70 years of either sex who belong to the American Society of Anesthesiologists ASA grade I or II are scheduled for proximal femoral nailing surgeries and require elective surgery only
Group HB – Total volume 3ml Hyperbaric Bupivacaine 2.5ml plus 0.5ml Fentanyl
Group IB – Total volume 3ml Isobaric Bupivacaine 2.5ml plus 0.5ml Fentanyl
To minimize bias in the level of block achieved with isobaric or hyperbaric bupivacaine a uniform total volume of 3 ml of the drug was administered slowly via the intrathecal route in both study groups.
On arrival in Operation Theatre, baseline blood pressure SBP DBP MAP heart rate respiratory rate and oxygen saturation were checked before conducting the procedure The drug solution was prepared by another clinician who was not a part of the study Patient’s HR RR BP and SpO2 were monitored continuously during the procedure Spinal anesthesia would be done under all aseptic conditions with the necessary precautions, in L3-L4 or L4-L5 interspace in sitting position with 25G Quincke needle via midline approach Patient will be immediately turned to supine and neutral position without any head-high or head-low so as to avoid bias. Blood pressure SBP DBP MAP heart rate respiratory rate and oxygen saturation would be monitored at every 5 minutes for the first 30 minutes then every 30 minutes till the end of surgerySensory blockade was assessed by pin prick test by using 22G hypodermic needle and Motor blockade was assessed by Modified Bromage scale Postoperatively VAS score is measured at every 30 minutes until rescue analgesia is given Patient would be monitored for complications like hypotension nausea vomiting headache shivering urinary retention and bradycardia for 24 hours
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