| CTRI Number |
CTRI/2022/07/044429 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| 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
|
A comparison of effects of ultrasound guided intermediate cervical plexus block and local anaesthetic infiltration for perioperative analgesia and introperative hemodynamic stability in patients undergoing retromastoid suboccipital craniotomy |
|
Scientific Title of Study
|
A COMPARISON OF EFFECTS OF ULTRASOUND-GUIDED INTERMEDIATE CERVICAL PLEXUS BLOCK AND LOCAL ANAESTHETIC INFILTRATION ON HEMODYNAMIC RESPONSE AND PERIOPERATIVE ANALGESIA IN PATIENTS UNDERGOING EXCISION OF CEREBELLOPOTINE ANGLE TUMORS WITH RETROMASTOID SUBOCCIPITAL CRANIOTOMY (RMSOC) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kandala Harika |
| Designation |
Junior Resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Flat no-102, udaya shine apartments, street no-7, Habsiguda, Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9618076075 |
| Fax |
|
| Email |
harika.kandala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Sri Lata |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute Of Medical Sciences |
| Address |
Department of Anesthesiology,Nims,Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9848352882 |
| Fax |
|
| Email |
srilatanims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kandala Harika |
| Designation |
Junior Resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Flat no-102, udaya shine apartments, street no-7, Habsiguda, Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9618076075 |
| Fax |
|
| Email |
harika.kandala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizam Institute of Medical Sciences, Punjagutta, Hyderabad, 500082 |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Department of Anesthesiology and critical care,NIMS,Punjagutta,Hyderabad, 500082 |
| 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 |
| Kandala Harika |
Nizams Institute of Medical Sciences |
Department of Anesthesiology and critical care,NIMS, Punjagutta,Hyderabad-500082
Hyderabad
TELANGANA |
9618076075
harika.kandala@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local anaesthetic infiltration and scalp block |
15ml 0.25% ropivacaine for local anaesthetic infiltration and 20ml 0.25% for scalp block |
| Intervention |
Ultrasound guided intermediate cervical plexus block and scalp block |
15ml of 0.25% ropivacaine for cervical plexus block and 15ml of 0.25% ropivacaine for scalp block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged between 18 to 60YEARS
2)Patients of both gender
3)Patients with ASA grade 1 and 2
4)Patients with Weight 40 to 80kg
5)Patients with any CP angle tumor with GCS-15
|
|
| ExclusionCriteria |
| Details |
1)Patients with known respiratory and cardiac problems
2)Patients with Congenital Diaphragmatic problems
3)Local sepsis
4)Bleeding diathesis
5)Hypersensitivity to local anaesthetics
6)Duration of surgery more than 4 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamics at pin insertion, skin incision and dural opening |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative analgesia as assessed by visual Analogue Scale,
SpO2, EtCO2, entropy |
1 year |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| 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 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
|
This is a prospective randomized controlled trail comparing the effect of ultrasound guided intermediate cervical plexus block and scalp block versus local anesthetic infiltration and scalp block on hemodynamic response and peri operative analgesia in patients umdergoing excision of cerebellopontine angle tumors with retromastoid suboccipital craniotomy. Total of 60 patients will be recruited with 30 in each group, group C - patients recieving ultra sound guided intermediate cervical plexus block and scalp block and group I - patients receiving local anaesthetic infiltration and scalp block. |