| CTRI Number |
CTRI/2026/01/100662 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Adding Dexamethasone to Scalp Nerve Block for Pain Relief After Brain Surgery |
|
Scientific Title of Study
|
Evaluation of dexamethasone as an adjuvant
for scalp nerve block for post operative
analgesia following supratentorial craniotomy |
| 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 Kirti Kshetrapal |
| Designation |
Profesor |
| Affiliation |
pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of anaesthesiology and critical care, pt. B.D. Sharma PGIMS
Rohtak
HARYANA
124001
India |
| Phone |
9215650615 |
| Fax |
|
| Email |
kamalkirti47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitish agarwal |
| Designation |
Junior Resident |
| Affiliation |
pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of anaesthesiology and critical care, pt. B.D. Sharma PGIMS
Rohtak
HARYANA
124001
India |
| Phone |
8708537472 |
| Fax |
|
| Email |
nitishagarwal18nov1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitish agarwal |
| Designation |
Junior Resident |
| Affiliation |
pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of anaesthesiology and critical care, pt. B.D. Sharma PGIMS
Rohtak
HARYANA
124001
India |
| Phone |
8708537472 |
| Fax |
|
| Email |
nitishagarwal18nov1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| pt. B.D. Sharma PGIMS Rohtak,Daryao nagar, Rohtak Haryana,India 124001 |
|
|
Primary Sponsor
|
| Name |
pt. B.D. Sharma PGIMS Rohtak |
| Address |
pt. B.D. Sharma PGIMS Rohtak Haryana 124001 |
| 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 Nitish Agarwal |
pt. B.D. Sharma PGIMS Rohtak |
Neurosugery operation theatre, Lala Shyam Lal Superspeciality Building,
Rohtak
HARYANA |
8708537472
nitishagarwal18nov1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Researcg Ethics Committee,Pt B.D. sharma PGIMS,rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
the scalp nerve block will be done before incision to patients undergoing supratentorial craniotomy |
the scalp nerve block will be done with 20ml of 0.5% bupivacaine,1ml of 100mcg/ml epinephrine plus 1 ml dexamethasone 10 min prior to surgery |
| Comparator Agent |
the scalp nerve block will be done before incision to patients undergoing supratentorial craniotomy |
the scalp nerve block will be done with 20ml of 0.5% bupivacaine,1ml of 100mcg/ml epinephrine plus 1 ml normal saline 10 min prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologist physical status classification 1-3, Glassgow coma scale(GCS) score of 15/15 schedule to undergo elective supratentorial craniotomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1)Patients having contraindications to regional anaesthesia
2)coagulation abnormalities
3)active infection at injection site
4)chronic pain syndromes
5)chronic opioid use(more than 2 weeks or 3 days per week for more than 1 month)
6)extreme body mass index(<15 or >35)
7)refusal or inability of patient or legal guardian to provide inform consent |
|
|
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 Visual Analogue Scale(VAS) for pain following scalp nerve block with local anaesthetic agents with or without addition of dexamethasone in patients undergoing supratentorial craniotomy under general anaesthesia |
vas scale for pain assessment will be done at baseline, 24hrs and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperatice heamodynamic parameter |
pre induction,before block,after block, before incision, after incision, 15 min,30 min, 1 hr, 2hr after incision |
| duration of postoperative analgesia |
|
| 24 hrs analgesic requirement |
|
| Demand to 1st rescue analgesia |
|
| postoperative nausea and vomiting |
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kirtikamal47@gmail.com].
- For how long will this data be available start date provided 28-12-2025 and end date provided 28-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is to evaluate the role of dexamethasone as adjuvant added to scalp nerve blocker postoperative analgesia following supratentorial craniotomy. Depending on whether Dexamethasone is used as adjuvant to provide postoperative analgesia following craniotomy, patients will be randomly allocated into two groups. Group S will include patient receiving drug alone while Group DS will receive dexamethasone along will drug ,10 min prior to surgery. Primary objective will be to compare Visual Analogue Scale for pain following Scalp nerve block, Secondary objective will be intraoperative heamodynamic parameter, duration of postoperative analgesia ,24hrs analgesic requirement. demand of first rescue analgesia ,post operative nausea and vomiting, drug related complication if any.Data will be compiled and appropriate stastical test will be used to analyse the results |