| CTRI Number |
CTRI/2023/08/056435 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
06/08/2023 |
| 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
|
Comparing Hyperbaric Levobupivacaine and Hyperbric Ropivacaine as spinal anesthetic drugs for elective lower limb orthopedic surgeries. |
|
Scientific Title of Study
|
To Study and Compare The Effect and Block Characteristic Of Hyperbaric Levo-
Bupivacaine Versus Hyperbaric Ropivacaine In Elective Lower Limb Orthopaedic
Surgeries Under Spinal Anaesthesia in Sub Himalayan Population- A Prospective,
Randomized, Triple-Blind Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aryan Jarial |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at TANDA |
| Address |
Department Of Anaesthesia Dr Rajendra Prasad Government Medical College, Kangra at TANDA
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418130777 |
| Fax |
|
| Email |
aryanjarial6494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dheeraj Singha |
| Designation |
Associate Professor |
| Affiliation |
Dr, Rajendra Prasad Government Medical College |
| Address |
Department Of Anaesthesia Dr Rajendra Prasad Government Medical College, Kangra at TANDA
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8091048700 |
| Fax |
|
| Email |
dheerajsinghaa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheeraj Singha |
| Designation |
Associate Professor |
| Affiliation |
Dr, Rajendra Prasad Government Medical College |
| Address |
Department Of Anaesthesia Dr Rajendra Prasad Government Medical College, Kangra at TANDA
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8091048700 |
| Fax |
|
| Email |
dheerajsinghaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR Rajendra Prasad Govt Medical College Kangra at Tanda |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government Medical college KANGRA at TANDA |
| Address |
Department of Anaesthesiology, Dr Rajendra Prasad Government Medical College KANGRA at TANDA |
| 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 Aryan Jarial |
Department of Anaesthesiology, Dr Rajendra Prasad Government Medical College Kangra At Tanda |
Department of Anaesthesiology O.T. Complex Second Floor Dr Rajendra Prasad Government Medical College and Hospital Kangra At Tanda
Kangra
HIMACHAL PRADESH |
9418130777
aryanjarial6494@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC Kangra at Tanda, Himachal Pradesh, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M971||Periprosthetic fracture around internal prosthetic knee joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Levobupivacaine 0.5% |
route- intrathecally
dose 15 mg
frequency -once onlyduring study foreach patient |
| Comparator Agent |
Standardised Hyperbaric Ropivacaine 0.75% |
dose - 0.75%
frequency - once only in the entire study
route - intrathecally
|
| Intervention |
Sub Arachanoid Block |
Spinal anaesthesia is type a of neuraxial anaesthesia technique which involves placing local anaesthetic directly in the intrathecal space (subarachnoid space). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with Body Mass Index (BMI) between 18 -29.9 kg/m2.
2)ASA I and II patients scheduled for elective lower limb orthopaedic surgery with anticipated
duration of surgery between 120 - 180 mins |
|
| ExclusionCriteria |
| Details |
1. Patients refusal for central neuraxial block.
2. Patients with BMI more than 30.
3. Patients allergic to the drugs under consideration.
4. Patients having absolute contraindication for spinal anaesthesia.
5. Primary or metastatic malignancy.
6. Patients with deformity of spine where drug spread is unpredictable.
7. Partial effect or failed spinal.
8. Patients in which space other than L3-L4 inter-vertebral space is used for instituting spinal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of the two drugs hyperbaric Levo-bupivacaine & hyperbaric Ropivacaine in subarachnoid block in terms of sensory and motor block characteristics. |
time required for onset and regression of sensory and motor blockade.
sensory and motor block at 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effect of drug on intra operative hemodynamic parameters of the patient, total vasopressor requirement between two groups & side effect of drug used if any. |
Hemodynamic parameters at 0, 3,6,9,12,15,20,25,30,35,40,45,50,55,60,65,70,75,80,85,90,95,100,105,110,115,120,125,130,135,140,145,150,155,160,165 minutes |
| Post operative haemodynamic parameters |
haemodynamic monitoring at 0,15,30,45,60,75,90,105,120,135,150,165,180,195,210,225,240 minutes |
|
|
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 4 |
|
Date of First Enrollment (India)
|
25/08/2023 |
| 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)
|
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
|
Spinal anaesthesia is type a of neuraxial
anaesthesia technique which involves placing local anaesthetic directly in the
intrathecal space (subarachnoid space). The first regional anaesthetic
technique performed was spinal anaesthesia, and the first operation under
spinal anaesthesia was performed in 1898 in Germany by August Bier. It
is highly popular among anaesthesiologists and commonly used worldwide.
The advantages of an awake patient, minimal drug costs, rapid patient turnover
coupled with fast onset, effective sensory, motor blockade and post-operative
analgesia with fast post-operative recovery has made it method of choice for
many surgical procedures..
|