| CTRI Number |
CTRI/2024/04/065232 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Ultrasound guided Superficial Cervical plexus block versus local infiltration for post operative analgesia in MRM |
|
Scientific Title of Study
|
A Randomized comparative study of ultrasound guided superficial cervical plexus block versus local infiltration for post operative analgesia in modified radical mastoidectomy†|
| 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 Trapti Singh |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Medical College and Research Centre , Moradabad |
| Address |
Room no 204 2nd floor Department of Anaesthesia Teerthanker
Mahaveer Medical college and research centre Moradabad Uttar
Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7905521552 |
| Fax |
|
| Email |
traptisingh.v@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Professor and HOD |
| Affiliation |
Teerthanker Medical College and Research Centre , Moradabad |
| Address |
Room no 204 2nd floor Department of Anaesthesia Teerthanker
Mahaveer Medical college and research centre Moradabad Uttar
Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
drmukeshprasad.medi@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Jain |
| Designation |
Associate Professor |
| Affiliation |
Teerthanker Medical College and Research Centre , Moradabad |
| Address |
Room no 204 2nd floor Department of Anaesthesia Teerthanker
Mahaveer Medical college and research centre Moradabad Uttar
Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9855567933 |
| Fax |
|
| Email |
payalravi1408@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College, Moradabad,UP |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh |
| Address |
Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh |
| Type of Sponsor |
Private 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 Trapti Singh |
Teerthanker Mahaveer Medical College and Research Centre |
Room no.4,Department of Anaesthesia Moradabad Uttar Pradesh
Moradabad
UTTAR PRADESH |
7905521552
traptisingh.v@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,TMU University,Moradabad,UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H709||Unspecified mastoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj ropivacaine 5ml in local infiltration |
VAS score and haemodynamic parameter will be recorded in PACU 0min, 5mins, 10mins , 15mins, 30mins then 1st hr, 4hr , 8hr, then after12hrs, 18hrs, and 24hrs.VAS 4 will be given rescue analgesia in form of I/V diclofenac 75mg. Total rescue analgesic consumption
in 24 hrs and complications will be noted.
|
| Intervention |
inj ropivacaine 5ml in USG guided Superficial Cervical Plexus Block |
VAS score and haemodynamic parameter will be recorded in PACU 0min, 5mins, 10mins , 15mins, 30mins then 1st hr, 4hr , 8hr, then after12hrs, 18hrs, and 24hrs.
VAS 4 will be given rescue analgesia in form of I/V diclofenac 75mg. Total rescue analgesic consumption in 24 hrs and complications will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patient under going modified radical mastoidectomy
Informed and written consent
ASA physical status I-II
|
|
| ExclusionCriteria |
| Details |
H/o Motion sickness
H/o of seizures, malignancy
Allergy to local anaesthesia |
|
|
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 Score VAS postoperatively in both groups
|
VAS score will be recorded in PACU 0min, 5mins, 10mins , 15mins, 30mins then 1st hr, 4hr , 8hr, then after12hrs, 18hrs, and 24hrs.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare time for first rescue analgesia in both groups.
To compare total consumption of analgesics in first 24 hours in both groups
.
To compare haemodynamical parameters in both groups.
|
Duration of analgesia(hr)- from onset of sensory block to first request for rescue analgesia
To compare total consumption of analgesics in first 24 hours in both groups.
hemodynamic parameters will be recorded in PACU 0min, 5mins, 10mins , 15mins, 30mins then 1st hr, 4hr , 8hr, then after12hrs, 18hrs, and 24hrs.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Regional blocks such as Superficial cervical plexus block (SCPB) and Local infiltration are both techniques used in post operative patients undergoing Modified Radical Mastoidectomy(MRM) surgery to reduce postoperative pain.
After getting approval from Institutional Ethical Committee (IEC) ,those patients who are fit in inclusion criteria will be included in our study
Randomization using computer generated random number which are sealed in opaque envelop will be done.
General anaesthesia will be given as per the institution’s protocol.
After surgery before extubation, SCPB and Local infiltration will be perfomed under the gudiance of ultrasound machine (Sonosite MicroMaxx P08840-22)with 5-10Hz linear probe using 5cm echogenic needle Group S-Ultrasound guided SCPB, 5ml Ropivacaine 0.5% Group L- Local infiltration, 5ml Ropivacaine 0.5%
The patient will be shifted to PACU and standard analgesia (1 gm PCM 8 hrly i/v) will be given as per standard institute protocol.
VAS score and haemodynamic parameter will be recorded in PACU 0min, 5mins, 10mins , 15mins, 30mins then 1st hr, 4hr , 8hr, then after12hrs, 18hrs, and 24hrs.
VAS >4 will be given rescue analgesia in form of I/V diclofenac 75mg. Total rescue analgesic consumption in 24 hrs and complications will be noted.
Data will be analyzed using the appropriate statistical method. |