| CTRI Number |
CTRI/2021/09/036479 [Registered on: 14/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| 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 pain killing effect of incision site injection of 0.75% Ropivacaine( numbing agent) versus blocking the nerves of scalp using 0.75% Ropivacaine in patients undergoing open skull surgeries under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of analgesic effect of incision site infiltration versus scalp nerve block with 0.75% Ropivacaine in cases undergoing supratentorial craniotomy under general anaesthesia: A randomized Interventional study, S.M.S. Medical college, Jaipur during the year 2020-2021. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobha Purohit |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Neurosurgery Operation Theatre, 1st floor Bangad building, SMS Medical college, Jaipur
Department Of Anaesthesiology,second floor, Dhanwantari building, SMS Medical college, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7737050823 |
| Fax |
|
| Email |
purohit.shobha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Purohit |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Neurosurgery Operation Theatre, 1st floor Bangad building, SMS Medical college, Jaipur
Department Of Anaesthesiology,second floor, Dhanwantari building, SMS Medical college, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7737050823 |
| Fax |
|
| Email |
purohit.shobha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali C |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department Of Anaesthesiology,second floor, Dhanwantari building, SMS Medical college, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9962329236 |
| Fax |
|
| Email |
vaishc93@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College and attached hospitals |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS Medical College |
| Address |
JLN Marg, Jaipur |
| 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 Vaishali C |
Department of Anaesthesiology, Neurosurgery operation theatre |
First floor,Neurosurgery OT, Bangad Parishar building,Gate no 5, SMS Medical College Hospital,JLN Marg, Ashok Nagar, Jaipur
Jaipur
RAJASTHAN |
9962329236
vaishc93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Incision site infiltration |
Incision site of surgery will be infiltrated with 15ml of 0.75% Ropivacaine after induction of anaesthesia |
| Intervention |
Scalp Nerve Block |
Scalp nerve Block will be given to the patient using 15ml of 0.75% Ropivacaine after induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I-III patients willing to give written and informed consent, GCS above 13,Weight of Patients between 40 to 75kg |
|
| ExclusionCriteria |
| Details |
History of allergy to anaesthetic agents used in the study, History of uncontrolled hypertension, arrhythmia, coagulation disorder, Past History of craniotomy surgery, Pregnancy, Any absolute or relative contraindication to study drug, Non communicative status, Psychiatric patients, Surgery more than 5 hours
|
|
|
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 |
| Mean time duration for the need of first rescue analgesia |
After the end of surgery in post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total dose of analgesia required |
24 hours starting from skin incision |
| change in intra-operative hemodynamic parameters |
Baseline, Just after induction, Just after intubation, Just after scalp nerve block/ incision site infiltration, Skin incision, 5 minutes after skin incision, 10 minutes after skin incision, During skull drilling, During dura opening and after every 15 minutes till the end of the surgery |
| change in mean C-Reactive Protein levels |
Baseline, 8hours after skin incision, 24hours after skin incision |
| percentage of cases who develop side effects |
After the end of surgery in postoperative period |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2021 |
| 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="0"
Months="10"
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
|
The study is randomized interventional study comparing the analgesic effect of incision site infiltration versus scalp nerve block using 0.75% ropivacaine in patients undergoing supratentorial craniotomy aged between 20 to 55 years by measuring mean time duration for the need of first rescue analgesia, total dose of analgesia required in 24 hours and change in CRP levels in 60 patients as the primary outcome. As the secondary outcome hemodynamic changes during surgery and side effects after surgery will be measured. This will be conducted in department of anaesthesiology, neurosurgery OT, SMS Medical college and hospital, Jaipur |