| CTRI Number |
CTRI/2025/04/085614 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| 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
|
Comparison of drug with adjuvant and drug alone in scalp block in craniotomy |
|
Scientific Title of Study
|
A comparative evaluation of scalp block using 0.5% bupivacaine with dexamethasone versus 0.5% bupivacaine alone for attenuating postoperative pain in patients undergoing supratentotial craniotomy under general anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhi Tiwari |
| Designation |
Junior Resident, Department Of Anaesthesia |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Department Of Anaesthesia, Sardar Patel Medical College, Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
7014835204 |
| Fax |
|
| Email |
Sweetsiddhi78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiwi Mantan |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department Of Anaesthesia, Sardar Patel Medical College, Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
9929092702 |
| Fax |
|
| Email |
kiwivyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiwi Mantan |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department Of Anaesthesia, Sardar Patel Medical College,Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
9929092702 |
| Fax |
|
| Email |
kiwivyas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College, Bikaner, Rajasthan, India
Pin Code: 334001 |
|
|
Primary Sponsor
|
| Name |
Sardar Patel medical college |
| Address |
DEPARTMENT OF ANAESTHESIA S.P Medical college Bikaner Rajasthan India
Pin Code 334001 |
| 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 Kiwi mantan |
Sardar Patel Medical College |
Department Of Anaesthesia ,OT A block, Sardar Patel Medical College, Bikaner
Bikaner
RAJASTHAN |
9929092702
kiwivyas@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: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scalp block for post operative analgesia in supratentorial craniotomy using bupivacaine with dexamethasone and bupivacaine alone |
After skin closure bilateral subcutaneous Infiltration of drug using landmarks using 20ml 0.5% bupivacaine with 2ml(8mg)dexamethasone each side versus 20ml bupivacaine alone is done for post operative pain in 24 hours
|
| Comparator Agent |
Scalp block using 0.5% Bupivacaine with dexamethasone versus 0.5% Bupivacaine alone |
Bilateral Scalp block using 0.5% inj bupivacaine 10ml with 1ml (4mg) dexamethasone each side versus 0.5% Inj bupivacaine alone 10ml with 1ml NS each side
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Posted for elective supratentorial craniotomy
BMI 18-30 Kg/m²
ASA grade I-II
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Known allergy to bupivacaine used in the study
Patient with ASA grade III and above
Glasgow Coma Score (GCS) less than 15
Hepatic, renal or cardiorespiratory failure
Patients undergoing emergency procedure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy and safety of bupivacaine and dexamethasone as adjuvant in scalp block for supratentorial craniotomy in terms of:
Duration of postoperative analgesia.
Requirement of first rescue analgesia and total number of rescue analgesics
|
Evaluate on the basis of VAS score in first 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe
Postoperative hemodynamic parameters
|
24 hour postoperatively |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
02/05/2025 |
| 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="0"
Months="4"
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
|
Our study aimed at comparing postoperative analgesia assessment using bupivacaine with dexamethasone and bupivacaine alone in scalp block for supratentorial craniotomy .
|