| CTRI Number |
CTRI/2025/02/080510 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| 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
|
A clinical trial to comparatively study 0.5 percentage hyperbaric levobupivacaine, 0.75 percentage hyperbaric ropivacaine and 0.5 percentage hyperbaric bupivacaine with fentanyl in subarachnoid block for lower limb surgeries. |
|
Scientific Title of Study
|
Comparative study of 0.5 percentage hyperbaric levobupivacaine, 0.75 percentage hyperbaric ropivacaine and 0.5 percentage hyperbaric bupivacaine with fentanyl in subarachnoid block for lower limb surgeries. |
| 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 M Rupinder Singh |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
9814046459 |
| Fax |
|
| Email |
drmrupindersinghdmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Japneet Bakhshi |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9501444357 |
| Fax |
|
| Email |
bakhshijapneet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Japneet Bakhshi |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9501444357 |
| Fax |
|
| Email |
bakhshijapneet@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical college and hospital, Ludhiana, Punjab 141001, India |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab 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 M Rupinder Singh |
Dayanad Medical College and Hospital |
Department of Anaesthesia, first floor, Dayanand Medical College and Hospital Tagore Nagar, Civil Lines Ludhiana 141001 Ludhiana PUNJAB
Ludhiana
PUNJAB |
9814046459
drmrupindersinghdmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee, dayanand medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative study of 0.5% hyperbaric levobupivacaine, 0.75% hyperbaric ropivacaine and 0.5% hyperbaric bupivacaine with fentanyl in subarachnoid block for lower limb surgeries. |
Patients in group B will receive 2.5 ml of 0.5 % of hyperbaric bupivacaine with 0.5ml ( 25mcg) of fentanyl intrathecally (total volume-3ml) |
| Comparator Agent |
Comparative study of 0.5% hyperbaric levobupivacaine, 0.75% hyperbaric ropivacaine and 0.5% hyperbaric bupivacaine with fentanyl in subarachnoid block for lower limb surgeries. |
Patients in group L will receive 2.5ml of 0.5% of hyperbaric levobupivacaine with 0.5( 25mcg) of fentanyl intrathecally (total volume-3ml). |
| Comparator Agent |
Comparative study of 0.5% hyperbaric levobupivacaine, 0.75% hyperbaric ropivacaine and 0.5% hyperbaric bupivacaine with fentanyl in subarachnoid block for lower limb surgeries. |
Patients in group R will receive 2.5ml of 0.75% of hyperbaric ropivacaine with 0.5( 25 mcg ) of fentanyl intrathecally(total volume -3ml) |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) gradeI, II and III. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal for subarachnoid block.
2. Patients with allergy to local anaesthetic drugs or any history of anaphylacticreaction to the drugs used.
3. Patients with coagulopathy evidenced by history and laboratory investigations.
4. Patients with infection at injection site
5. Patients with spinal deformities like kyphoscoliosis and scoliosis etc.
6. Patients with history of pre-existing neurological disease.
7. Unable to comprehend sensory and motor block.
8. Patient’s refusal for consent.
9. Patients with failed spinal anaesthesia and subsequent conversion to general anaesthesia. |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory and motor block |
0 min, 2min, 4min, 6min, 8min , 10min ,15min and thereafter every 15min till two dermatome regression from maximum level of sensory block occurs |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine highest level and duration of sensory block.
2. Duration of motor block
|
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
12/03/2025 |
| 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="0"
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
|
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Brief Summary
|
Bupivacaine is the most commonly used intrathecal local anaesthetic ,but due to CNS and CVS toxicity associated with it lead to research of better alternatives for spinal anaesthesia. Studies have reported that hyperbaric 0.5% ropivacaine produce reliable subarachnoid block but of shorter duration than 0.5 % hyperbaric bupivacaine and 0.5 % hyperbaric levobupivacaine.A prospective randomized double blind study is planned to be conducted on 195 adult ASA grade I, II, III patients posted for lower limb surgeries under spinal anaesthesia after taking a written informed consent. Enrolled patients will be randomly divided into three equal groups to receive either 2.5ml of 0.5% hyperbaric levobupivacaine with , 2.5ml of 0.75% hyperbaric ropivacaine and 2.5ml of 0.5% hyperbaric bupivacaine with 25µg fentanyl (total volume-3ml) in subarachnoid block. Patient will be observed for duration of sensory block, time of onset of sensory and motor block, maximum sensory level, time to achieve maximum sensory level, time to complete motor block, time required for complete motor regression, duration of analgesia and hemodynamic parameters. This study will help us to compare 0.5% hyperbaric levobupivacaine, 0.75% hyperbaric ropivacaine and 0.5% hyperbaric bupivacaine in combination with fentanyl in terms of clinical efficacy and safety profile for use in lower limb surgeries under subarachnoid block
|