| CTRI Number |
CTRI/2025/06/088874 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of 2 medicine, for spinal anesthesia in lower limb surgeries in adult patients. |
|
Scientific Title of Study
|
A randomized comparative study between hyperbaric levobupivacaine and hyperbaric levobupivacaine with dexmedetomidine in lower limb surgeries in adult patients under subarachnoid block |
| 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 Biruj Mahalia |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College |
| Address |
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh,
250004
India
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh,
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9582338327 |
| Fax |
|
| Email |
birujmahalia7272@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Varun |
| Designation |
Associate Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College |
| Address |
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh,
250004
India
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh,
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9568766156 |
| Fax |
|
| Email |
nickysangeeta78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biruj Mahalia |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College |
| Address |
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh,
250004
India
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh,
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9582338327 |
| Fax |
|
| Email |
birujmahalia7272@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Lala Lajpat Rai Memorial Medical college Meerut Uttar Pradesh 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM medical college |
| Address |
Department of Anaesthesiology Lala Lajpat Rai Memorial Medical college Meerut Uttar Pradesh 250004 |
| 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 Biruj Mahalia |
Lala Lajpat Rai Memorial Medical College Meerut |
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut, 250004, Uttar Pradesh
Meerut
UTTAR PRADESH |
9582338327
birujmahalia7272@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the principal, LLRM medical college, meerut,Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S82||Fracture of lower leg, including ankle, (2) ICD-10 Condition: S82||Fracture of lower leg, including ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. Levobupivacaine heavy 0.5% |
Inj. Levobupivacaine heavy 0.5% 15mg injected in Lumber 3rd and lumber 4th intervertebral subarachnoid space of spine. |
| Comparator Agent |
Inj. Levobupivacaine heavy 0.5% 15mg plus 5mcg inj Dexmedetomidine. |
Inj. Levobupivacaine heavy 0.5% 15mg plus 5mcg inj Dexmedetomidine injected in between lumber 3rd and Lumber 4th intervertebral subarachnoid space of spine. |
| Intervention |
Subarachnoid block |
Drug is given in Lumber 3rd and lumber 4th intervertebral subarachnoid space in all participants of the study. Onset and duration of sensory and motor blockade evaluated. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2, age 18-65 years of either sex, patient undergoing elective lower limb surgeries. |
|
| ExclusionCriteria |
| Details |
Patient refusal, ASA grade 3 and 4, known allergy or hypersensitivity to local anaesthesic drugs, infection at the injection site, bleeding diathesis or coagulopathy, pre existing ischaemic heart disease, diabetes mellitus and hypertension, CNS disorder-epilepsy and raised intracranial tension, severe renal, hepatic, hematological, metabolic disorder, cardiac malformation, spinal deformity, pregnancy, COPD, Asthma, chronic bronchitis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the efficacy of the drugs |
Onset of sensory and motor blockade will be assessed at different time intervals till the complete effect or for 30 minutes after injection.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate onset and duration of sensory block in both the groups, to compare and evaluate onset and duration of motor block in both groups. |
Sensory and motor blockade will be evaluated every 1 minute for initial 5 min and every 2 min for next 10 min till the complete effect. |
| Hemodynamic changes if any- heart rate, mean arterial pressure, systolic blood pressure , diastolic blood pressure, SpO2. |
Heart rate, mean arterial pressure, systolic blood pressure , diastolic blood pressure, SpO2 will be recorded immediately after procedure and every 2 min for initial 10 min, every 5 min for next 30 min and at 15 min interval till completion of the surgery. |
| To compare and evaluate time of first rescue analgesia in both groups. |
Patient to be assessed for 12 hours for rescue analgesia |
| Complications |
Patient to be assessed for 24 hours post operatively. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="3"
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
|
This study is prospective randomized comparative study between hyperbaric levobupivacaine and hyperbaric levobupivacaine with dexmedetomidine in lower limb surgeries in adult patients under subarachnoid block. Primary objective of this study is to compare the efficacy of the drugs and to compare and evaluate the onset and duration of sensory and motor blockade in both the study groups. Hemodynamic changes- heart rate, mean arterial pressure, systolic and diastolic blood pressure. Also to compare and evaluate time of first rescue analgesia and complications if any. |