| CTRI Number |
CTRI/2024/04/065483 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of levobupivacaine0.5%vs ropivacaine 0.75% mixed with dexmedetomidine after lumbar epidural anaesthesia in long bone surgeries |
|
Scientific Title of Study
|
Comparison of efficacy, BIS value and haemodynamic spectrum of levobupivacaine 0.5% versus ropivacaine 0.75% with dexmedetomidine as an adjuvant following lumbar epidural anaesthesia in long bone 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 Poonam Lata Singh Thakur |
| Designation |
PG resident |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Room No.418,4th Floor,Department of Anaesthesia,Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College
Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9131264520 |
| Fax |
|
| Email |
poonamlata1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smriti Bandhu |
| Designation |
Associate Professor |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Rajnandgaon |
| Address |
Department of Anaesthesiology, Room No 418,4th floor, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
7000562486 |
| Fax |
|
| Email |
drsmriti19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Lata Singh Thakur |
| Designation |
PG resident |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Department of Anaesthesia,Room No.418,4th Floor,
Bharat Ratna late shri atal bihari vajpayee memorial medical College,
Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9131264520 |
| Fax |
|
| Email |
poonamlata1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharat Ratna late Shri Atal Bihari Vajpayee memorial Medical College,Pendri,Rajnandgaon,Chhattisgarh pin code 491441 |
|
|
Primary Sponsor
|
| Name |
Bharat ratna late shri atal bihari vajpayi Rajnandgaon |
| Address |
Department of anaesthesia Bharat Ratna late shri Atal bihari vajpayee rajnandgaon chhattisgarh |
| 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 |
| Poonam Lata Singh Thakur |
Bharat ratna late shri atal bihari vajpayi memorial Medical College,Rajnandgaon |
Room No. 418,4th Floor,Department of Anaesthesiology,Bharat Ratna late Shri Atal Bihari Vajpayee memorial Medical College,Pendri Rajnandgaon CHHATTISGARH
Rajnandgaon
CHHATTISGARH |
9131264520
poonamlata1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BRLSABVM MEDICAL COLLEGE RAJNANDGAON |
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 |
1.Levobupivacaine 0.5% 20ml
2.Ropivacaine0.75% 20ml
3.Dexmedetomidine 0.5mcg/kg 2ml |
Comparison of efficacy, BIS value and Haemodynamic spectrum of Levobupivacaine 0.5% vs Ropivacaine 0.75% with dexmedetomidine as an adjuvant following Lumbar epidural anaesthesia in long bone surgeries .
Total Duration: 90-200 Minutes |
| Intervention |
Lumbar Epidural Anaesthesia |
Lumbar epidural block is given at L3-L4 intervertebral space via 18G/16G tuohys epidural needle using LOR technique.epidural catheter is inserted then test dose 2% lignocaine adrenaline 1/200000 2.5-3ml is given.
Total duration- 90-200 Minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 year
ASA I-II
BMI (18.5-35)
Either gender
Patients undergoing elective long bone surgeries
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Bilateral lower limb surgeries
Focal neurological deficits
Inability to understand VAS
Coagulation disorders
Severe spinal deformities
Infection at the site of block
Pre existing peripheral neuropathy
Uncontrolled Diabetes mellitus
Known hypersensitivity to Local anaesthetics |
|
|
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 |
1.Characteristic of motor & sensory block (min)
2.BIS index score
|
SENSORY BLOCK
1: Onset time to T10 - time taken for sensory blockade to pain at T10 level since the time of Drug injection by Pin Prick Method
2: Maximal sensory level
3: Time to maximal Sensory level
4: Time to two dermatome regression
5: Time to regression to T10 6: Time to regression to L1
MOTOR BLOCK
1 :Time to complete block as per Modified Bromage Scale
2 :Time to complete recovery
BIS Score Index :0 to 180 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of adverse effects 2.Requirements of 1st Rescue analgesic
3.Duration of analgesia 4.Patient satisfaction |
Till 6 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/04/2024 |
| 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="0"
Months="3"
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
|
|
Brief Summary
|
STUDY TITLE: Comparison of efficacy, BIS value and Haemodynamic spectrum of Levobupivacaine 0.5% vs Ropivacaine 0.75% with dexmedetomidine as an adjuvant following Lumbar epidural anaesthesia in long bone surgeries . RATIONALE : Is there any difference in the clinical efficacy BIS value and haemodynamic spectrum of epidural 0.5% levobupivacaine and 0.75% ropivacaine with dexmedetomidine as an adjuvant on the level of duration of sensory and motor blockade following lower limb surgeries? Is there any significant difference in the incidence of adverse events following epidural anaesthesia with administration of 0.5% levobupivacaine and 0.75% ropivacaine? AIM: To compare the clinical efficacy, BIS value and Haemodynamic spectrum of Levobupivacaine 0.5% vs Ropivacaine 0.75% with dexmedetomidine as an adjuvant following Lumbar epidural anaethesia in long bone surgeries OBJECTIVES: Efficacy , BIS value and Haemodynamic spectrum of test drugs The level and duration of sensory and motor block STUDY PLACE: B.R.L.S.A.B.V.M.Medical college ,Rajnandgaon STUDY DESIGN: Prospective Randomized interventional double blind study TIME FRAME: April 2024 –June 2024 STUDY APPROVAL : Institutional Scientific & Ethics Committee POPULATION/PARTICIPANTS: Patients scheduled for elective surgeries at B.R.L.S.A.B.V.M. Medical college, Rajnandgaon from April 2024 – June 2024 |