| CTRI Number |
CTRI/2025/03/082207 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
randomised control trial |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is a study to see the analgesic effect of ultrasound guided superficial cervical plexus block in mastoid surgeries wherein the efficacy of local anaesthetic is compared. |
|
Scientific Title of Study
|
Comparative evaluation of analgesic effect of ultrasound guided superficial cervial plexus block in mastoid surgeries. |
| 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 Ashish Kumar Kannaujia |
| Designation |
Professor |
| Affiliation |
|
| Address |
department of Anaesthesiology
Sanjay Gandhi Postgraduate Institute Of Medical Sciences, halibut mawaiya, raeberelli road, 226014
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9451982660 |
| Fax |
|
| Email |
ashishkannaujia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Ashish Kumar Kannaujia |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department Of Anaesthesiology
Sanjay Gandhi Postgraduate Institute of Medical Sciences, halibut mawaiya, raeberelli road, Lucknow 226014.
UTTAR PRADESH 226014 India |
| Phone |
9451982660 |
| Fax |
|
| Email |
ashishkannaujia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR Ashish Kumar Kannaujia |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology
Sanjay Gandhi Postgraduate Institute of medical sciences, haibut dawaiya, raeberelli road 226014
UTTAR PRADESH 226014 India |
| Phone |
9451982660 |
| Fax |
|
| Email |
ashishkannaujia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of medical sciences |
| Address |
Department of anaesthesiology, Sanjay Gandhi Postgraduate Institute of medical sciences, halibut maw dawaiya, raeberelli, Lucknow 226014 |
| 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 |
| DR Ashish Kumar Kannaujia |
Sanjay Gandhi Postgraduate Institute of Medical SCciences |
ENT operation theatre, department of Neuro-otology ENT, OT complex old building. Lucknow UTTAR PRADESH |
9451982660
ashishkannaujia77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical 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 |
total rescue analgesia in 24 hours in patients with ultrasound guided superficial cervical plexus block in mastoid surgery with dexamethasone |
superficial cervical plexus block via ultrasound guidance in patients undergoing mastoid surgery with dexamethasone using .25% bupivacaine with 2ml or 8 mg dexamethasone. frequency- block placed once. block effect assessed for 24 hours |
| Comparator Agent |
total rescue analgesia namely 75 mg diclofenac slow iv in 24 hours in patients with ultrasound guided superficial cervical plexus block in mastoid surgery without dexamethasone used as additive. |
superficial cervical plexus block via ultrasound guidance in patients undergoing mastoid surgery using .25% bupivacaine(8ml) without dexamethasone. frequency- block administered once, duration- followed for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I and II patients.
2. Age between 18-70 years,
3. Both male and female patients.
4. Elective mastoid surgery under General Anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Altered neck anatomy (Previous neck surgeries etc.)
3. Previous ear surgeries
4. Seizure disorder
5. Diabetes mellitus
6. Pregnancy and lactating females
7. Motion sickness
8. Local site infection
9. Allergy to drugs
10. Substance abuse
11. Migraine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia which will be assessed by the time of the first dose of rescue analgesia needed after block placement if VAS score is greater than four at baseline and at 24 hours. |
at baseline
at 24 hours after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total analgesic consumption
2. Hemodynamic parameters intraoperatively & postoperatively
3. Incidence of post operative nausea & vomiting (PONV)
|
For 24 hours after placement of the block the patients shall be monitored |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
01/04/2025 |
| 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="1" 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
|
Mastoid surgeries are one of the commonest ear surgeries performed globally. Tradi8onally these surgeries are performed under general anaesthesia and have several issues like risk of post opera8ve pain and PONV. For pain management intraopera8vely and postopera8vely opioids are the mainstay, however opioids have their own problems like postopera8ve respiratory depression, hypoxia and nausea vomi8ng. With development of mul8modal analgesia, various blocks have been advocated for beDer post opera8ve pain management like SCPB. However, there are limited studies enumera8ng the effect of superficial cervical plexus block (SCPB) in mastoid surgeries. The limita8on of SCPB is dura8on of analgesia so various aDempts have been made to increase the dura8on by adding adjuvant medica8on. Dexamethasone is a popular adjuvant for peripheral nerve blocks but these studies are mostly related to brachial plexus blocks. There is one study of use of dexamethasone in SCPB in thyroid surgeries where it has shown beDer pain control in the post opera8ve period. But we could not find any study of SCPB in which dexamethasone has been used in mastoid surgery. The primary objec8ve of the study is to observe the dura8on of analgesia which will be assessed by the 8me of the first dose of rescue analgesia if VAS score is greater than four. The secondary objec8ves will be to see the total analgesic consump8on, hemodynamic parameters intraopera8vely and postopera8vely and the incidence of post opera8ve nausea and vomi8ng (PONV). Following approval from the ins8tu8onal ethics commiDee and registering the trial at CTRI, a wriDen informed consent will be obtained from the pa8ents. The study will be done for a period of 18 months. Pa8ents will undergo preanaesthe8c checkup a night before surgery. General anaesthesia with endotracheal tube inser8on (midazolam/fentanyl/propofol/vecuronium) will be done. Pa8ents will be divided in two groups. Group B- 8ml(0.25%) bupivacaine Group D-8ml(0.25%)bupivacaine +2ml normal saline +2ml dexamethasone The pa8ent will be in supine posi8on with the ipsilateral shoulder on the side of block propped up and the head turned to contralateral side. The site of interest will be painted and draped with the superficial cervical plexus block being placed in all asep8c precau8ons with a high frequency linear ultrasound probe (5-13 MHz). At the end during skin suturing all pa8ents will receive i.v ondansetron and paracetamol 1gm i.v. The residual neuromuscular blockade will be reversed a_er the pa8ent is fully responsive and awake.The pa8ent will be then shi_ed to post opera8ve care unit (PACU) for observa8on and monitoring. All the pa8ents will receive i.v paracetamol 1g/8 hourly in the postopera8ve period. Rescue analgesic will be provided with diclofenac 75mg in 100ml normal saline slow I.V over 30 minutes if the VAS score is greater than 4. All pa8ents will be monitored for the first dose of rescue analgesia, total dose of rescue analgesia consump8on, nausea vomi8ng and adverse events in the post operative period. |