| CTRI Number |
CTRI/2021/09/036839 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different modalities of anaesthesia in inguinal hernia surgery. |
|
Scientific Title of Study
|
Comparative study of spinal anaesthesia and paravertebral block in inguinal hernia repair. |
| Trial Acronym |
SA, PVB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhuvnesh Kumar |
| Designation |
PG 3rd year Resident in Anaesthesia department |
| Affiliation |
Sardar Patel Medical College |
| Address |
DEPARTMENT OF ANAESTHESIA
S.P. Medical College
Bikaner
Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
7339770364 |
| Fax |
|
| Email |
bhuvnesh06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Dhawan |
| Designation |
Senior Professor and Head |
| Affiliation |
Sardar Patel Medical College |
| Address |
DEPARTMENT OF ANAESTHESIA
S.P. Medical College
Bikaner
Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
9414137866 |
| Fax |
|
| Email |
sonaligsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Dhawan |
| Designation |
Senior Professor and Head |
| Affiliation |
Sardar Patel Medical College |
| Address |
DEPARTMENT OF ANAESTHESIA
S.P. Medical College
Bikaner
Rajasthan
RAJASTHAN
334001
India |
| Phone |
9414137866 |
| Fax |
|
| Email |
sonaligsoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College, Bikaner, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner Rajasthan |
| Address |
Department of Anaesthesiology, Sardar Patel Medical College Bikaner, Rajasthan |
| 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 Sonali Dhawan |
Sardar Patel Medical College, Bikaner, Rajasthan |
Department of Anaesthesiology,
PBM Hospital Bikaner, Rajasthan
Bikaner
RAJASTHAN |
9414137866
sonaligsoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical and Research Board, Sardar Patel Medical College, Bikaner. |
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 |
Paravertebral Block |
30ml bupivacaine with 50μg dexmedetomidine given in paravertebral space at T12 to L2 level in unilateral inguinal hernia repair surgeries |
| Comparator Agent |
Spinal anesthesia |
3ml Hyperbaric bupivacaine with 5μg dexmedetomidine given in spinal anesthesia for unilateral inguinal hernia repair surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for inguinal hernia repair
2. Age between 18-70 years
3. ASA physical status I, II and III
4. No systemic illness and complications |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal
2. ASA physical status >III
3. History of bleeding and coagulation disorder
4. Allergic to local anaesthetic agents
5. Infection at local site
6. Head injury and increased intracranial pressure
7. Neurological disease or psychotic disorder
8. Severe anaemia
9. Hemodynamic instability
10. Cardiac or hepatic or renal disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Spinal Anaesthesia & Paravertebral block in terms of
Duration and characteristics of block & hemodynamic stability. |
Up to 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Spinal Anaesthesia & Paravertebral block in terms of
1. Ambulation time and Readiness to discharge.
2. Surgeon’s and Patient’s satisfaction score. |
Up to 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
26/09/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our aim is compare post operative analgesia and readiness to discharge in both groups of spinal anaesthesia and paravertebral block |