| CTRI Number |
CTRI/2026/03/105996 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of ultrasound guided nerve block in reducing restlessness after nasal surgery |
|
Scientific Title of Study
|
To study the efficacy of ultrasound guided suprazygomatic maxillary nerve block for prevention of emergence agitation in patients undergoing nasal 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 M Rupinder Singh |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9814046459 |
| Fax |
|
| Email |
drmrupindersinghdmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhavi Garg |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9056132165 |
| Fax |
|
| Email |
chhavigarg22092000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhavi Garg |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9056132165 |
| Fax |
|
| Email |
chhavigarg22092000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar ,Civil lines,Ludhiana ,141001 Punjab India |
| 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 |
| Chhavi Garg |
Dayanand medical college and hospital , Ludhiana |
Dayanand medical college and hospital , Tagore nagar , Ludhiana , Punjab (141001)
Ludhiana
PUNJAB |
9056132165
chhavigarg22092000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research & Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J348||Other specified disorders of noseand nasal sinuses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficacy of ultrasound guided Suprazygomatic Maxillary nerve block for prevention of emergence agitation in patients undergoing nasal surgeries |
in group Y no block will be given after induction of General anaesthesia |
| Intervention |
Efficacy of ultrasound guided Suprazygomatic Maxillary nerve block for prevention of emergence agitation in patients undergoing nasal surgeries |
Patients in group Z will recieve b/l USG guided Suprazygomatic Maxillary nerve block after induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18-60 years posted for elective nasal surgeries under general anaesthesia of American Society of Anaesthesiologists Class l-lll |
|
| ExclusionCriteria |
| Details |
1. Refusal to participate in study
2.Allergy to local anaesthetic used
3.Coagulopathy
4.Chronic opioid use
5.Psychiatric / neurological illness |
|
|
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 |
| Incidence and severity of emergence agitation |
Immediately after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain scores (VAS), postoperative analgesic requirementover 24 hours (tramadol) and time of first rescue analgesia |
0,1,2,4,6,12,24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
22/03/2026 |
| 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="29" |
|
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
|
Nasal surgeries are often associated with postoperative discomfort due to nasal packing and postoperative pain. This if inadequately controlled my lead to patient discomfort and higher incidence of emergence agitation. Use of opioids in post operative period is often associated with many side effects. Use of regional anaesthesia techniques like ultrasound guided suprazygomatic maxillary nerve block may offer targeted pain relief with minimal side effects thus decreasing emergecne agitation and opioid consumption. A prospective ,double blinded,randomized study will be conducted on a total of 126 patients posted for elective nasal surgeries under general anaesthesia. These patients will be randomly allocated into 2 groups. The technique of general anaesthesia will be standardized in both groups. Group Z will recieve b/l ultrasound guided suprazygomatic maxillary nerve block with 5 ml of 0.5% bupivacaine and group Y will recieve no block. The aim is to study the efficacy of ultrasound guided suprazygmatic maxillary nerve block for prevention of emergence agitation in patients undergoing nasal surgeries. The primary outcome of this study is to assess the severity and incidence of emergence agitation using sedation agitation scale and secondary outcome is to assess postoperative pain scores and analgesia requirement. |