| CTRI Number |
CTRI/2025/07/091051 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of spinal anaesthesia of Injection Hyperbaric Bupivacaine mixed with Injection Fentanyl followed by Injection Isobaric Bupivacaine compared with Injection Hyperbaric Bupivacaine mixed with Injection Fentanyl in lower limb fractures in old age patients. |
|
Scientific Title of Study
|
Efficacy of sequential intrathecal injection of Hyperbaric Bupivacaine-Fentanyl followed by Isobaric Bupivacaine compared with Hyperbaric Bupivacaine-Fentanyl in orthopaedic lower limb surgeries in geriatric patients: A prospective randomised double blind clinical 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 Shreenidhi Patel |
| Designation |
Resident Doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College, Baroda |
| Address |
Department of Anaesthesia,2nd floor, New surgical Building, Government Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9737338876 |
| Fax |
|
| Email |
shree7033@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashmira Pander |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College,Baroda. |
| Address |
Department of Anaesthesia,2nd floor, New surgical Building, Government Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9099045151 |
| Fax |
|
| Email |
dr.kashmira13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreenidhi Patel |
| Designation |
Resident Doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College, Baroda |
| Address |
Department of Anaesthesia,2nd floor, New surgical Building, Government Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9737338876 |
| Fax |
|
| Email |
shree7033@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Baroda, Gujarat, India. Pincode-390001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Baroda. |
| Address |
Department of Anaesthesiology, New Surgical Block, SSG Hospital Vadodara,390001, Gujarat, 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 Shreenidhi Patel |
SSG Hospital |
1st Floor, Department of Orthopaedics, SSG Hospital, Government Medical College, Baroda
Vadodara
GUJARAT |
9737338876
shree7033@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical and health research, government medical college baroda |
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 |
Inj. Hyperbaric Bupivacaine 10 milligram with Inj. Fentanyl 25 microgram (premixed) |
After pre-anesthetic evaluation, patients meeting the inclusion criteria will be selected. In the operation theatre, necessary equipments and drugs to be kept ready. Spinal anaesthesia will be given in L3-L4 intervertebral space in intrathecal route. Patients will be divided into two groups. In HB group, Inj. Hyperbaric Bupivacaine 10 milligram with Inj. Fentanyl 25 microgram will be given intrathecally without barbotage. Patient is immediately put in supine position without raising extremities and monitoring of parameters will be started immediately. Sensory and motor blockade, requirement of Inj. Ephedrine will be observed. |
| Intervention |
Inj. Hyperbaric Bupivacaine 5 milligram with Inj. Fentanyl 25 microgram followed sequentially by Inj. Isobaric Bupivacaine 5 milligram |
After pre-anesthetic evaluation, patients meeting the inclusion criteria will be selected. In the operation theatre, necessary equipments and drugs to be kept ready. Spinal anaesthesia will be given in L3-L4 intervertebral space through intrathecal route. Patients will be divided into two groups. In HIB group, Inj. Hyperbaric Bupivacaine 5 milligram with Inj. Fentanyl 25microgram followed by Inj. Isobaric Bupivacaine 5 milligram will be given intrathecally without barbotage. • Patient is immediately put in supine position without raising extremities and monitoring of parameters will be started immediately. Sensory and motor blockade, requirement of Inj. Ephedrine will be observed. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Age Group from 65 years to 99 years
2) Either Gender.
3) ASA grading including grade II/III
4) Orthopaedic lower limb surgeries
5) Duration of surgery: 2.5 to 3 hours
6) Patients providing written informed consent
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal.
2) Patients with local skin infection, Vertebral column abnormalities, bleeding disorders, cardiopulmonary disease, neuropathies.
3) Patients with allergy to study drugs.
4) BMI more than 30kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe haemodynamic stability (blood pressure, pulse rate) and number of doses of Inj. Ephedrine (5mg) i.v. required |
Till 8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess Sensory and Motor blockade characteristics– like
Onset of sensory block at L1 dermatomal level(mins)
Time to achieve maximum sensory level (mins)
Maximum sensory block achieved
Time for two segment regression(mins)
Total duration of sensory block (Time to regress till S1 dermatome) (mins)
Onset of motor blockade (Modified Bromage 1) (mins)
Time to achieve maximum motor blockade (mins)
Duration of motor blockade (mins)
To observe any complications like bradycardia, hypotension, respiratory depression, urinary retention, shivering.
|
Till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
16/07/2025 |
| 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="0"
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 aim of this study is to compare the efficacy of sequential injection of hyperbaric bupivacaine with fentanyl followed by isobaric bupivacaine and hyperbaric bupivacaine with fentanyl intrathecally and to study the haemodynamic effects and recovery in lower limb surgeries in geriatric patients. 84 patients for lower limb orthopaedic surgeries will be randomly allocated in two different groups. In each group, there will be 42 patients who are posted for elective or emergency lower limb orthopaedic surgeries.In one group HIB group, Inj. Hyperbaric Bupivacaine 1 ml with Inj. Fentanyl 0.5ml followed by Inj. Isobaric Bupivacaine 1ml will be given intrathecally without barbotage. In second group, HB group, Inj. Hyperbaric Bupivacaine 2 ml with Inj. Fentanyl 0.5ml will be given intrathecally.
As the primary outcome, haemodynamic stability (blood pressure, pulse rate) and number of doses of Inj. Ephedrine (5mg) i.v. required will be observed. As the secondary outcome, comparison of sensory and motor blockade characteristics will be assessed.
The proposed advantage of this study is that the sequential intrathecal administration of Inj. Hyperbaric Bupivacaine+ Inj. Fentanyl followed by Inj. Isobaric Bupivacaine may be helpful in reduction of intraoperative hypotension and subsequent lower vasopressor requirements in geriatric patients while achieving satisfactory block characteristics (e.g., onset, intensity, and duration) when compared to Inj. Hyperbaric Bupivacaine+ Inj. Fentanyl alone. |