| CTRI Number |
CTRI/2025/11/098221 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
to compare 2 ultrasound based nerve blocks for patients who undergo elective ear surgery |
|
Scientific Title of Study
|
Comparison of ultrasound guided lesser occipital & greater auricular nerve
block (LOGAB) versus superficial cervical plexus block for postoperative analgesia in
adults undergoing elective mastoid surgery under general anaesthesia: A randomized
controlled trial |
| 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 Ravneet Kaur Gill |
| Designation |
Assistant Professor |
| Affiliation |
Dr B R Ambedkar State Institute of Medical Sciences |
| Address |
Dept of Anaesthesia, OT complex, first floor, Block 1, Dr B R Ambedkar State Institute of Medical Sciences, Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
9501988361 |
| Fax |
|
| Email |
drravneetkgill@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravneet Kaur Gill |
| Designation |
Assistant Professor |
| Affiliation |
Dr B R Ambedkar State Institute of Medical Sciences |
| Address |
Dept of Anaesthesia, OT complex, first floor, Block 1, Dr B R Ambedkar State Institute of Medical Sciences, Mohali
PUNJAB
160055
India |
| Phone |
9501988361 |
| Fax |
|
| Email |
drravneetkgill@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravneet Kaur Gill |
| Designation |
Assistant Professor |
| Affiliation |
Dr B R Ambedkar State Institute of Medical Sciences |
| Address |
Dept of Anaesthesia, OT complex, first floor, Block 1, Dr B R Ambedkar State Institute of Medical Sciences, Mohali
PUNJAB
160055
India |
| Phone |
9501988361 |
| Fax |
|
| Email |
drravneetkgill@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar State Institute of Medical Sciences, Mohali, Punjab.India 160055 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Dept of Anaesthesia, Dr B R Ambedkar State Institute of Medical Sciences |
| Type of Sponsor |
Other [self] |
|
|
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 Ravneet Kaur Gill |
Dr B R Ambedkar State Institute of Medical Sciences |
Dept of Anaesthesia, OT Complex first floor
Rupnagar
PUNJAB |
9501988361
drravneetkgill@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - HUMAN RESEARCH (IEC-HR) |
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 |
Control group |
will receive conventional analgesia with IV Fentanyl intraoperatively and Inj.
PCM 1 g in the intraoperative period for the postoperative period. A band-aid/sterile dressing will be placed at the same site as that of the blocks to blind the assessor to the intervention administered to
the patient. |
| Intervention |
LOGAB Block |
Patient will receive ultrasound guided LOGAB block with 5 ml of 0.25% ropivacaine 5 minutes after induction of general anaesthesia |
| Intervention |
SCB Block |
Patient will receive superficial cervical block with 10 ml of 0.25% ropivacaine 5 minutes after induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for elective mastoid surgery
2.ASA I-II patients |
|
| ExclusionCriteria |
| Details |
1. Presence of local infection or impaired skin integrity at the injection site
2. Any cognitive or psychiatric condition that prevents comprehension and completing
the outcome measures
3. Patients receiving anticoagulant therapy
4. Pregnancy or breastfeeding
5. Previous neck surgery or radiation |
|
|
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 |
To compare the postoperative pain intensity (by Numerical
Rating Scale) between the groups. |
Baseline, 0,5,10,15,30,45,60,75,90,105,120,135,150,165,180,195,210 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the intraoperative hemodynamic profile between the groups (HR, SBP,
DBP and MAP) at various time points. |
0,5,10,15,30,45,60,75,90,105,120,135,150,165,180,195,210 minutes |
To compare the time to demand of first rescue analgesia and the total dose of rescue
analgesia in first 48 hours post operatively between the groups |
post operative period |
To note any adverse events such as allergic reactions, local anaesthetic toxicity,
infection, hematoma, Horner’s syndrome and phrenic nerve palsy |
in post operative period 48 hours |
To assess the quality of recovery of the patient using the QoR-15 score in the
postoperative period. |
in post operative period 48 hours |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
10/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drravneetkgill@gmail.com].
- For how long will this data be available start date provided 20-11-2025 and end date provided 20-11-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Mastoid surgeries are now commonly performed for middle ear pathologies. They are usually associated with moderate degree of post operative pain. Various modalities like intravenous NSAIDs, opioids and regional nerve blocks are used to attenuate the degree of post operative pain.(1) In regional anaesthesia techniques, superficial cervical plexus block, greater auricular nerve block, auriculotemporal nerve block are often used for pain relief Study Design: A randomized prospective, placebo-controlled trial Study Duration: 1 year Participants will be randomized into 3 groups using a computer-generated table. Concealment of allocation will be done with sealed, numbered, opaque, white envelopes which will be opened after the patient is taken into the OR. Group I (n=25): will receive ultrasound guided LOGAB (lesser occipital greater auricular block) with 5 ml of 0.25% Ropivacaine Group II (n=25): will receive ultrasound guided superficial cervical plexus block with 10 ml of 0.25% Ropivacaine. Group III (n=25): will receive conventional opioid analgesia only. |