| CTRI Number |
CTRI/2025/03/082553 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the duration of motor block using either of 0.5percent hyperbaric bupivacaine 0.5percent hyperbaric levobupivacaine and 0.5percent isobaric levobupivacaine for spinal anaesthesia in Total Knee Replacement surgery. |
|
Scientific Title of Study
|
Randomized Comparative Study to Assess the Efficacy of 0.5percent
Hyperbaric Bupivacaine 0.5percent Hyperbaric Levobupivacaine and 0.5percent Isobaric Levobupivacaine
for Spinal Anaesthesia in total Knee Replacement Surgery |
| 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. Ankita Rai |
| Designation |
Junior Resident |
| Affiliation |
King George’s Medical University |
| Address |
Room no. 10
Department of Anaesthesiology
KGMU
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8299428656 |
| Fax |
|
| Email |
dr.raiankita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Aparna Shukla |
| Designation |
Additional Professor |
| Affiliation |
King George’s medical university |
| Address |
Room no. 08
Department of Anaesthesiology
KGMU
Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9918038878 |
| Fax |
|
| Email |
shukla.draparna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Aparna Shukla |
| Designation |
Additional Professor |
| Affiliation |
King George’s Medical University |
| Address |
Room no 08
Department of Anaesthesiology
KGMU
Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9918038878 |
| Fax |
|
| Email |
shukla.draparna@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrAnkita Rai |
| Address |
ROOM NO 3, DEPARTMENT OF ANAESTHESIOLOGY, KING GEORGES MEDICAL UNIVERSITY, CHOWK, LUCKNOW |
| Type of Sponsor |
Other [Self] |
|
|
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 Rishabh Mishra |
King George’s Medical University |
Orthopaedic Operating Room no. 01
4th floor ,Orthopaedic building , Daliganj , Lucknow , 226003
Lucknow
UTTAR PRADESH |
8896565970
mishrarishabh715@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University, Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA grade 1-3 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine heavy 0.5percent |
Efficacy of spinal anaesthesia in patients undergoing total knee replacement surgery from intrathecal injection of drugs till 20 minutes |
| Comparator Agent |
Levobupivacaine heavy 0.5percent |
Efficacy of spinal anaesthesia in patients undergoing total knee replacement surgery from intrathecal injection of drugs till 20 minutes |
| Comparator Agent |
Levobupivacaine plain 0.5percent |
Efficacy of spinal anaesthesia in patients undergoing total knee replacement surgery from intrathecal injection of drugs till 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1-3 |
|
| ExclusionCriteria |
| Details |
A)Patient refusal
B) Patients below 18 years of age and above 70years of age
C) Morbid obese
D)ASA IV
|
|
|
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 |
| Duration of motor block (T4) |
Just after subarachnoid block i.e At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for onset of sensory & motor block (T1 & T2 respectively)
• Duration of sensory block (T3)
• Time to first rescue analgesia (T5) |
Just after subarachnoid block i.e At baseline |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|
Brief Summary
|
This is a double-blinded randomised comparative study involving 81patients between 18 and 70 undergoing elective total knee replacement surgery and is graded ASA grade [American Society of Anesthesiologists] I-III. After obtaining ethical approval from the institute and written informed consent from all patients, they will be randomly divided into three groups of 27 using a computer-generated table and the opaque envelope technique. Before undergoing anesthesia, every patient will undergo a pre-anesthetic evaluation.After transferring the patient to the operating table, we will attach monitors for ECG (electrocardiogram), Spo2 (peripheral capillary oxygen saturation), and NIBP (noninvasive blood pressure). Additionally, we will secure an 18-G intravenous catheter and administer 10 ml/kg of Ringer’s lactate to the patient over 10 minutes. Before anaesthesia, we will explain the sensory and motor assessment method to the patient. To perform a sub-arachnoid block, we will use a 25 G Quinke spinal needle and inject the 3 ml study drug slowly over 15 seconds (according to the group allocation] in the L3/L4 intervertebral space after confirming free-flowing cerebrospinal fluid. Patients will be placed in the supine position immediately after intrathecal injection. The surgical procedure can be initiated only after the sensory block of at least T12 level has been reached, along with a motor block of modified Bromage grade 2 or less. If these conditions are not met within 20 minutes, the spinal anaesthesia is considered unsuccessful, and the procedure will be converted to general anaesthesia.After injecting the intrathecal drug, the study parameters will be observed by an anaesthesiologist who is blinded to the type of drug given to the patient. The onset of the sensory block will be defined as the time taken for loss of sharp sensation with the pinprick test until the T12 dermatome level after injecting the drug (T1). The recordings will be noted every minute for the 20 min. The time taken to achieve adequate motor block (T2), defined as a score of 2 on the modified Bromage scale, will be recorded by testing the motor block every minute until a score of 2 is achieved. The motor blockade will be assessed using the modified Bromage scale (modified Bromage scale: 1 = unable to move feet or knees, 2 = able to move feet only, 3 = just able to move knees, 4 = full flexion of knees with detectable weakness of hip flexion while supine, 5 = no detectable weakness of hip flexion while supine, 6 = able to perform partial knee bend). Surgery will commence once adequate sensory (T12) and motor (modified Bromage 2) blocks are achieved. Maximum level of sensory block achieved will also be noted If there is inadequate sensory or motor block after 20 minutes, the patient will be excluded from the study. Patients undergoing surgery will be transferred to the post-anesthesia care unit for continuous monitoring. During this time, their sensory level and motor blockade will be checked every 10 minutes. The duration of the sensory block (T3) will be measured from the onset of the sensory block (T12 level) to the point of regression of the sensory block to the L4 dermatome. The duration of the motor block (T4) will be measured from the onset of the motor block (as defined by the modified Bromage scale 2) to the achievement of the modified Bromage scale six after the surgery. Additionally, the interval between administering the subarachnoid block and the patient’s first request for supplemental analgesia will be recorded (T5).Blood pressure and heart rate will be monitored every minute for the first 10 minutes and then every 5 minutes until the surgery is completed. If the systolic blood pressure (SBP) falls below 90 mmHg or there is a decrease of 20% or more from the baseline value, it will be considered a hypotensive episode. To manage hypotension, 250 ml of Ringer’s lactate will be infused quickly, and incremental doses of intravenous mephentermine, starting with 3 mg, will be given. Clinically relevant bradycardia, defined as a heart rate (HR) below 50 bpm, will be managed with incremental doses of 0.3 mg intravenous atropine. Total dose of atropine or mephentermine required will be noted. Side effects like hypotension, bradycardia, nausea and vomiting will be noted. |