| CTRI Number |
CTRI/2025/08/092729 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Bupivacaine temperature on spinal block characteristics. |
|
Scientific Title of Study
|
Comparison of the effect of intrathecal Bupivacaine at two different temperatures on spinal block characteristics in adults undergoing arthroscopic knee 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 |
Shashank Shekhar Singh |
| Designation |
Postgraduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care VMMC and Safdarjung hospital New Delhi
South
DELHI
110029
India |
| Phone |
7827373924 |
| Fax |
|
| Email |
shashankss1606@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parul Mullick |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi
South
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parul Mullick |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi
South
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi 110029 |
| 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 |
| Shashank Shekhar Singh |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive care
South
DELHI |
7827373924
shashankss1606@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal 2.8mL of 0.5percent Hyperbaric Bupivacaine at 24 degree temperature |
2.8mL of 0.5 percent Hyperbaric Bupivacaine intrathecal block for duration less than two hours surgery |
| Intervention |
Intrathecal 2.8mLof 0.5 percent Hyperbaric Bupivacaine at 30 degree temperature |
2.8mL of 0.5 percent Hyperbaric Bupivacaine intrathecal block for duration less than two hours surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged 18 to 65 years belonging to American Society of Anaesthesiologists physical status class 1 or 2, undergoing lower limb arthroscopic surgery under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Pregnancy, obese with BMI more than 35, Height shorter than 160cm and taller than 175cm, known spinal anomaly, local infection, coagulopathies, on anticoagulant or having any contraindication to spinal anaesthesia. |
|
|
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 |
| To compare the effect of intrathecal 2.8mL 0.5 percent Hyperbaric Bupivacaine at temperatures, 24 and 30 degree Celsius, on spinal block characteristics in term of the time of onset of sensory block in adults undergoing arthroscopic knee surgery. |
At baseline, after 5 minutes interval till 30minutes then at 10 minutes interval till 2hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of intrathecal 2.8mL 0.5percent hyperbaric Bupivacaine at temperatures, 24 & 30 degree Celsius, on the level & duration of sensory block in adults undergoing arthroscopic knee surgery. |
Baseline, at 5 minutes interval till 30 minutes then after at interval of 10 minutes till 2 hours |
| To compare the effect of intrathecal 2.8mL of 0.5 Percent hyperbaric Bupivacaine at temperatures, 24 & 30 degree Celsius, on time to onset & duration of motor block in adults undergoing arthroscopic knee surgery. |
Baseline, at interval of 5minutes till 30 minutes there after at interval of 10 minutes till 2hours |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
25/08/2025 |
| 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 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
|
The present study aims to bridge the gap by comparing the effects of intrathecal Bupivacaine at 24and 30 degree Celsius, focusing on onset time of sensory block in patients undergoing lower limb arthroscopic surgeries. Identifying the optimal temperature may allow clinicians to enhance block characteristics while maintaining safety and feasibility in routine clinical practice. |