| CTRI Number |
CTRI/2025/07/090363 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Methods of Numbing the Scalp During Brain Tumor Surgeries : Using Ultrasound Guidance vs Traditional Technique. |
|
Scientific Title of Study
|
Effectiveness of Ultrasonograph Guided approach Vs landmark guided approach scalp block in comparing peri-operative rescue analgesia and anaesthesia requirement in patients undergoing craniotomy for suprasellar tumors. A randomized, Comparative study. |
| 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 YECHURI HARISH KUMAR |
| Designation |
Junior resident (M.D.) |
| Affiliation |
Nizams Institute of medical sciences |
| Address |
Department of Anaesthesiology and intensive care, Nizams institute of medical sciences, punjagutta Hyderabad, Telangana, India.
Hyderabad
TELANGANA
500082
India |
| Phone |
8142390650 |
| Fax |
|
| Email |
harish7702274743@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MONINGI SRILATA |
| Designation |
Professor |
| Affiliation |
Nizams Institute of medical sciences |
| Address |
Department of Anaesthesiology and intensive care, Nizams institute of medical sciences, punjagutta Hyderabad, Telangana, India.
Hyderabad
TELANGANA
500082
India |
| Phone |
9848352882 |
| Fax |
|
| Email |
srilatanims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MONINGI SRILATA |
| Designation |
Professor |
| Affiliation |
Nizams Institute of medical sciences |
| Address |
Department of Anaesthesiology and intensive care, Nizams institute of medical sciences, punjagutta Hyderabad, Telangana, India.
Hyderabad
TELANGANA
500082
India |
| Phone |
9848352882 |
| Fax |
|
| Email |
srilatanims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute Of Medical Sciences, Panjagutta ,Hyderabad District, Telangana State, INDIA.
Pincode 500082 |
|
|
Primary Sponsor
|
| Name |
Dr Yechuri Harish Kumar |
| Address |
Junior resident (M.D.), Department of anaesthesiology and intensive care,Nizams institute of medical sciences, punjagutta, Hyderabad, 500082, Telangana. Ph no. 8142390650, harish7702274743@gmail.com |
| Type of Sponsor |
Other [Nizams Institute Of Medical Sciences, Panjagutta ,Hyderabad, Telangana . Pincode 500082] |
|
|
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 YECHURI HARISH KUMAR |
Nizams institute of medical sciences |
Department of anaesthesiology and intensive care, Nizams institute of medical sciences, panjagutta,
Hyderabad, Telangana,
500082
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
8142390650
harish7702274743@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nims institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G935||Compression of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Landmark Guided Scalp Block |
A landmark-guided scalp block is a regional anesthesia technique used to anesthetize the sensory nerves of the scalp without the use of ultrasound. It relies on palpation of bony and soft tissue landmarks to guide the injection of local anesthetic.
This technique is especially useful in settings where ultrasound is unavailable or impractical, such as emergency care, trauma, or in resource-limited environments.
Approximate Duration of the intervention is around 10 to 15 minutes.
|
| Intervention |
Ultrasound Guided Scalp Block |
Ultrasound-Guided Scalp Block is a regional anesthesia technique used for perioperative analgesia in procedures involving the scalp, such as craniotomies, scalp laceration repair, or even certain cosmetic surgeries. It targets the sensory nerves supplying the scalp and uses ultrasound guidance for increased accuracy and safety.
Approximate Duration of the intervention is around 15 to 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I & II
2. Age 18 to 60 years
3. Gender : Both Male & Female
4. Informed and written consent
5. Tumors less than 6 cm size
6. Patients extubated on table |
|
| ExclusionCriteria |
| Details |
1. Patients with deranged coagulation profile
2. Patients with allergic history to local anesthetics
3. Pregnancy
4. Patients refusal
5. Patients with fever
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare peri-operative rescue analgesia and anesthesia requirement. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate intra operative hemodynamic responses in patients undergoing craniotomy surgeries during skull insertion, scalp incision & dural incision.
2.To evaluate post operative pain
3.To evaluate post operative nausea & vomiting.
Edit || Delete
|
Patients are monitored continuously till 24Hours after the surgery. |
|
|
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)
|
01/08/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
13. Scalp Blocks are usually performed blindly according to bony or superficial landmarks. But several studies reported important variations in foramina position or numbers or nerves course making sometimes blind placement of these hazardous blocks. The application of skull pin head holder which is used to stabilise the head during neurosurgical procedures and the scalp incision produce an intense nociceptive stimulus that results in sudden increase in blood pressure and cerebral blood flow even under deeper planes of General anaesthesia. Supraorbital nerve, Supratrochlear nerve, Auriculotemporal nerve, Zygomaticotemporal nerve, Greater auricular nerve and Lesser occipital nerve are a few nerve blocks used in Scalp Block for Craniotomy surgeries. There is very sparse literature of USG guided Scalp block in Craniotomy surgeries and comparing the efficacy of these two approaches. We designed this prospective study to compare the USG guided and Landmark guided approach for Scalp block in maintaining the intra operative hemodynamics and post operative analgesia of the patient. |