| CTRI Number |
CTRI/2024/12/077524 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Hyperbaric Levobupivacaine with Hyperbaric Bupivacaine in spinal anesthesia along with fentanyl in patients undergoing -Total abdominal hysterectomy- A single Blind study
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Scientific Title of Study
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A Comparitive study of Hyperbaric Levobupivacaine with Hyperbaric Bupivacaine in spinal anesthesia with adjuvant fentanyl in patients undergoing -Total abdominal hysterectomy- A single Blinded study
|
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirti Pandey |
| Designation |
Junior Resident |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Department of Anaesthesia,
Heritage Institute of Medical Sciences, NH-2, Bhadawar, Varanasi
Bhadawar, Varanasi.
Varanasi
UTTAR PRADESH
2211311
India |
| Phone |
8447136107 |
| Fax |
|
| Email |
drkirti8386@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushkar Ranjan |
| Designation |
Professor |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Heritage Institute Of Medical Science.
NH-2, Bhadawar, Varanasi
Bhadawar, varanasi.
Varanasi
UTTAR PRADESH
2211311
India |
| Phone |
9415986684 |
| Fax |
|
| Email |
pushkarranjanbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirti Pandey |
| Designation |
Junior Resident |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Heritage Istitute of Medical Sciences, Bhadawar, Varanasi
Bhadawar, varanasi.
Varanasi
UTTAR PRADESH
2211311
India |
| Phone |
8447136107 |
| Fax |
|
| Email |
drkirti8386@gmail.com |
|
|
Source of Monetary or Material Support
|
| Heritage institute of medical sciences, Bhadawar, Varanasi, Uttar Pradesh-221311 |
|
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Primary Sponsor
|
| Name |
Heritage Institute of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences,Bhadawar, varanasi, Uttar Pradesh, India pin code- 221311 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kirti pandey |
Heritage institute of medical sciences |
Gynae O.T. Complex, Department Of Anaesthesiology.
Varanasi
UTTAR PRADESH |
08447136107
drkirti8386@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HIMS - Institutional Ethical Commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local Anaesthetic Agent |
Injection levobupivacain (3ml) and injection bupivacain (3ml) with adjuvant injection Fentanyl 25cc |
| Intervention |
Spinal Anaesthesia |
Injection bupivacaine (3ml) and levobupivacain(3ml) with injection fentanyl(25cc) will be given intrathecaly for spinal anaesthesia in patients undergoing transabdominal hysterectomy.
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1-Patient aged 30 -65 yr.
2- ASA grade I, II.
Â
|
|
| ExclusionCriteria |
| Details |
1-patient refusal
2-patients with coagulation disorders or on anticoagulants, spinal deformity, allergic to amide local anaesthetics,
4-Patients with musculoskeletal and psychiatric diseases that could make our technique difficult
5-surgeries lasting for more than 1.5hr.
|
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Alternation |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare efficacy of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric bupivacaine with adjuvant fentanyl in terms of sensory and motor block in patients undergoing total abdominal hysterectomy.
|
Onset of sensory block- recording every minute for first 10 min then every 5min will be done. Max height of sensory block (T5/6) will be recorded.
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Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect on change in hemodynamics parameter and side effects using these same drugs.
|
After injecting the drug hemodynamic parameters (NIBP, Pulse Rate, Pulse Oxymetry) changes will be recorded every 5min till the end of the surgery |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
In this study 60 patients will be randomly allocated into two groups of 30 each . The patient will be unaware about the drug. Depending on the drug regime used for spinal anaesthesia as Group B: receiving 3ml of 0.5% hyperbaric bupivacaine (15 mg) and Group L: receiving 3ml of 0.5% hyperbaric levobupivacaine (15 mg). Each group will receive an equal amount of 25 mcg of opioid fentanyl as an adjuvant drug . After injecting the drug hemodynamic parameters (NIBP, Pulse Rate, Pulse Oxymetry) changes will be recorded every 5min till the end of the surgery.For Onset of sensory block- recording every minute for first 10 min then every 5min will be done. Max height of sensory block (T5/6) will be recorded.(VAS score).Motor blockade using Modified bromage will be done till score of 2 will be achieved, testing every minute .Variables- hemodynamics parameter, NIBP (non invasive blood pressure monitoring, Pulse Rate,Pulse Oxymetry. Measuring indicators- VAS (Visual Analogue Scale, Modified Bromage Scale
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