| CTRI Number |
CTRI/2014/06/004688 [Registered on: 20/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
20/11/2019 |
| 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
|
A study to compare the pain relief and other associated effects during surgery and in the immediate post-operative period of a local anaesthetic drug ropivacaine alone and along with a steroid (which prolongs the drug effect) injected into the scalp, in patients undergoing brain surgery |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL TRIAL TO COMPARE THE EFFECT OF SCALP BLOCK USING ROPIVACAINE ALONE OR ROPIVACAINE ALONG WITH ADJUVANT DEXAMETHASONE IN PATIENTS UNDERGOING SUPRATENTORIAL CRANIOTOMY UNDER GENERAL ANAESTHESIA (G.A.) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Jose |
| Designation |
Asssistant Professor |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Dr. Riya Jose
C/O Dr. Mithun Jacob Varghese
Dept. of Cardiology
C.M.C.Hospital
Vellore 632004
Tamil Nadu
India
Same are Address 1
Vellore
TAMIL NADU
632004
India |
| Phone |
9486170456 |
| Fax |
|
| Email |
riyamithun@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Grace Korula |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital Vellore |
| Address |
Dr. Grace Korula
Professor and Head of Anaesthesiology Unit 3 Department of Anaesthesiology C.M.C. Hospital
Vellore
Same as Address 1
Vellore
TAMIL NADU
632004
India |
| Phone |
9952121136 |
| Fax |
00914162232035 |
| Email |
grace.korula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riya Jose |
| Designation |
Asssistant Professor |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Dr. Riya Jose
C/O Dr. Mithun Jacob Varghese
Dept. of Cardiology
C.M.C.Hospital
Vellore 632004
Tamil Nadu
India
Same are Address 1
TAMIL NADU
632004
India |
| Phone |
9486170456 |
| Fax |
|
| Email |
riyamithun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant, Institutional Review Board, Christian Medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Fluid Research Grant Christian Medical College and Hospital Vellore |
| Address |
Christian Medical College and Hospital, Vellore 632004
Tamil Nadu
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Riya Jose |
Chrsitian Medical College and Hospital, Vellore |
Dept. of Anaesthesiology, Christian Medical College and Hospital, Vellore
Vellore
TAMIL NADU |
9486170456
riyamithun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, Supratentorial space-occupying lesions in the brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 ml of normal saline |
In the control arm of the study, 2 ml of normal saline was added to 30 ml of 0.2% ropivacaine given as a single dose subcutaneously in the scalp nerve block. |
| Intervention |
Dexamethasone 8 mg |
8 mg (2 ml) of dexamethasone added to 30 ml of 0.2% ropivacaine given subcutaneously as a single dose in the scalp nerve block in the study arm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiology Class I to III
Supratentorial intra-cranial space-occupying lesions
Pre-op GCS 15/15 |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone previous craniotomy
2. Hypertensive patients on beta blockers
3. Patients diagnosed with diabetes mellitus
4. Pre-operative Glasgow Coma Scale (GCS) less than 15
5. Pregnant patients
6. Patients with known allergy to local anaesthetics
7. Patients with peptic ulcer disease
8. Patients with coagulopathy
9. Patients with scalp infection
10. Patients who refused to give consent to participate in the study
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare duration of post-operative analgesia afforded by addition of dexamethasone as adjuvant to local anaesthetic ropivacaine in scalp nerve blocks with plain ropivacaine in patients undergoing supratentorial craniotomy |
Post-op pain was assessed using Visual Analogue Scale (VAS) score at zero hours, 4 hours, 8 hours, 12 hours and 24 hours post-op. The time when the first dose of post-op rescue analgesic was given was noted. The total duration of analgesia was computed from the time of administration of the scalp nerve block till the time of first post-op rescue analgesic. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the following parameters in the patients who receive plain ropivacaine in the scalp nerve block and those who receive ropivacaine as well as dexamethasone in the scalp block:
- intra-operative anaesthetic requirement
- time to emergence from general anaesthesia
- incidence of post-operative nausea and vomiting
|
up to 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2012 |
| Date of Study Completion (India) |
08/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a double blinded randomized control trial studying the effect of adding dexamethasone (a steroid) as an adjuvant to scalp nerve blocks with local anaesthetic 0.2% ropivacaine, in patients undergoing supratentorial craniotomy under general anaesthesia. One group of patients received 8 mg (2 ml) of dexamethasone along with the local anaesthetic in the scalp nerve block and the other group received 2 ml of normal saline. The study drug (dexamethasone or saline) was blinded to the patient, prinicipal investigator and outcome assessor. The primary outcome assessed was the duration of post-operative analgesia afforded by addition of dexamethasone to the scalp nerve block. This was defined as the time from administration of the scalp nerve block up to the time to first rescue analgesic post-operatively. They secondary outcomes assessed include a comparison of the intra-operative anaesthetic requirements (measured by the intra-operative used of opioid fentanyl and induction agent propofol), the time to emergence from general anaesthesia as well as incidence of post-op nausea and vomiting between the two groups. Both groups of patients were followed up for 24 hours after the surgery to assess the primary and secondary outcomes. Presently. 100 patients have been recruited of which 90 patients have been allocated to the 2 groups: 45 in each arm. The interim analysis is underway. |