| CTRI Number |
CTRI/2025/09/095149 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare motor and sensory block characteristics in diabetic and non diabetic patients and comparing effect of two different spinal drugs in each group |
|
Scientific Title of Study
|
Evaluation of sensory and motor block characteristics of spinal anaesthesia in diabetic and non diabetic patients undergoing infra umbilical surgeries using 0.5 percent hyperbaric bupivacaine and 0.75 percent hyperbaric ropivacaine. A randomised controlled study |
| 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 Prachi Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad medical College |
| Address |
Department of Anaesthesiology and intensive care
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9891449305 |
| Fax |
|
| Email |
prachigupta598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munisha Agarwal |
| Designation |
Director professor and Dean |
| Affiliation |
Maulana Azad medical College |
| Address |
Deans office
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604216 |
| Fax |
|
| Email |
munisha.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad medical College |
| Address |
Department of Anaesthesiology and intensive care
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9891449305 |
| Fax |
|
| Email |
prachigupta598@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and lok nayak hospital, 2 Bahadur Shah Zafar Marg, new delhi-110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002 |
| 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 Prachi Gupta |
Maulana Azad Medical College and associated Lok Nayak Hospital |
Ot block, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI |
9891449305
prachigupta598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
spinal anaesthesia using hyperbaric bupivacaine |
comparing motor and sensory block characteristics using hyperbaric bupivacaine in non diabetic and diabetic patients at every minute for first 10 min, then
every 2 min for the next 10 min. No rise in sensory block for 2 consecutive readings will be taken as
maximum sensory block level. Time to reach T10 dermatomal level and maximum sensory block level will
be noted. Simultaneously, Motor block will be assessed at the same time points. Time to achieve onset of
motor block (Modified Bromage score 1), maximum motor block achieved and time to reach maximum
motor block will be noted. Thereafter, sensory and motor block will be assessed every 15 min for 2 segment
sensory level regression and return to Modified Bromage score 1 respectivel |
| Intervention |
spinal anesthesia using hyperbaric ropivacaine |
comparing motor and sensory block characteristics using hyperbaric ropivacaine in non diabetic and diabetic patients at every minute for first 10 min, then
every 2 min for the next 10 min. No rise in sensory block for 2 consecutive readings will be taken as
maximum sensory block level. Time to reach T10 dermatomal level and maximum sensory block level will
be noted. Simultaneously, Motor block will be assessed at the same time points. Time to achieve onset of
motor block (Modified Bromage score 1), maximum motor block achieved and time to reach maximum
motor block will be noted. Thereafter, sensory and motor block will be assessed every 15 min for 2 segment
sensory level regression and return to Modified Bromage score 1 respectively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.height between 150-180cm
2.BMI between 19-30kg per meter square
3.ASA grade 1,2,3 |
|
| ExclusionCriteria |
| Details |
1.pregnancy
2.patients with known hypersensitivity to known drugs
3.patients with overt sensory sensory or motor deficit suggestive of diabetic neuropathy |
|
|
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 |
| mean time to 2 segment regression of sensory block level |
every 15 minute after achieving maximum sensory block level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mean time to achieve onset of sensory block (T10 dermatomal level) |
every 1 minute for first 10 min , then every 2 minute for next 10 min |
| maximum sensory block achieved |
every 1 minute for first 10 min then every 2 min for next 10 min |
| Mean time to achieve maximum sensory block level |
Every 1 minute for first 10 minutes then every 2 min for the next 10 minutes |
| Mean time to achieve onset of motor block ( modified bromage score 1) |
Every 1 minute for first 10 minutes then every 2 min for the next 10 minutes |
| Maximum motor block achieved |
Every 1 minute for first 10 minutes then every 2 min for the next 10 minutes |
| Mean time to achieve maximum motor block |
Every 1 minute for first 10 minutes then every 2 min for the next 10 minutes |
| Mean time to achieve regression of motor block ( from maximum block to modified bromage score 1) |
Every 15 minute after achieving maximum block level |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
10/10/2025 |
| 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="0"
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
|
This randomized controlled study aims to evaluate and compare the sensory and motor block characteristics of spinal anaesthesia in diabetic and non-diabetic patients undergoing infraumbilical surgeries using two local anaesthetics 0.5 percent hyperbaric bupivacaine and 0.75 percent hyperbaric ropivacaine. Diabetes mellitus is known to alter nerve conduction and sensitivity to local anaesthetics, potentially influencing block dynamics. The study will assess onset time, peak block level, and regression of both sensory and motor blocks, as well as the effect of CSF sugar and protein levels on these characteristics. A total of 56 patients will be randomized into four groups (diabetic/non-diabetic and bupivacaine/ropivacaine). The findings will help guide safer and more effective anaesthetic drug selection, particularly for diabetic patients, and support enhanced recovery practices in infra umbilical surgeries. |