| CTRI Number |
CTRI/2025/09/095108 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of post operative pain relief using Dexamethasone or Dexmedetomidine as additive to Bupivacaine in ultrasound guided superficial cervical plexus block after Mastoid surgery. |
|
Scientific Title of Study
|
Comparative evaluation of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in ultrasound guided Superficial Cervical Plexus Block for post operative analgesia in patients undergoing mastoid surgery . |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akansha Chona |
| Designation |
PG Student |
| Affiliation |
ESIC Medical College and Hospital, Faridabad |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9899963951 |
| Fax |
|
| Email |
akanshachona19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Soni |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital, Faridabad |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9654235054 |
| Fax |
|
| Email |
meghasoniarora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Jain |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College and Hospital, Faridabad |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
7043693398 |
| Fax |
|
| Email |
jainmansi@aol.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Faridabad 121001 Haryana |
|
|
Primary Sponsor
|
| Name |
Dr Akansha Chona |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital Faridabad 121001 |
| 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 Akansha Chona |
ESIC Medical College and Hospital Faridabad |
Department of Anaesthesiology ESIC Medical College and Hospital Faridabad 121001
Faridabad
HARYANA |
9899963951
akanshachona19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College & Hospital Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H712||Cholesteatoma of mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ultrasound guided superficial cervical plexus block |
Ultrasound guided superficial cervical plexus block using 5 ml of 0.25% bupivacaine and 4 mg dexamethasone as adjuvant . |
| Comparator Agent |
ultrasound guided superficial cervical plexus block |
ultrasound guided superficial cervical plexus block using 5 ml of 0.25% bupivacaine and 25mcg dexmedetomidine as adjuvant . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients belonging to American Society of Anaesthesiologists (ASA) physical status I or II
2 Body mass index 18 to 30 kg/m²
3 Patients undergoing elective mastoid surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Local infection at site of block
2. Bleeding disorders or patients on anticoagulants.
3. History of allergy to study drugs
4. Pregnant or lactating female
5. Patients with cognitive impairment
|
|
|
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 |
| Time of first rescue analgesia post operatively |
Time of first rescue analgesia post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain score (Numerical rating scale) |
postoperatively at 30 minutes, 1 hour, 4 hours, 8 hours, and 24 hours. |
| Post operative sedation score (Ramsay sedation scores) for sedation |
Post operatively at 30 minutes, 1 hour, 4 hour, 8 hour, and 24 hour. |
| Postoperative haemodynamic parameters. |
Postoperatively at 30 minutes, 1 hour, 4 hour, 8 hour, and 24 hour. |
| Total rescue analgesic requirement in first 24 hour postoperatively. |
|
| Incidence of PONV in first 24 hour postoperatively. |
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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 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
|
Study Title:Comparative evaluation of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in ultrasound guided superficial cervical plexus block for post operative analgesia in patients undergoing mastoid surgery Study Type: randomised controlled study Objective: To compare the effect of dexamethasone versus dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided superficial cervical plexus block for post operative analgesia in patients undergoing mastoid surgery . Participants: Patients of either sex , aged 18-60 yrs with American Society of Anaesthesiologist Physical Status I/II , BMI 18-30 kg/m2, scheduled for elective mastoid surgery under general anaesthesia .
Interventions: Group A: Patients will be given Ultrasound guided Superficial cervical plexus block using 5 ml of 0.25% bupivacaine and 4 mg dexamethasone as adjuvant . Group B: Patients will be given Ultrasound guided Superficial cervical plexus block using 5 ml of 0.25% bupivacaine and 25mcg dexmedetomidine as adjuvant .
Primary Outcome: To evaluate and compare the duration of post operative analgesia using dexmedetomidine vs dexamethasone as an adjuvant to bupivacaine in ultrasound guided superficial cervical plexus block in patients undergoing mastoid surgery. Secondary Outcomes: To evaluate and compare:- 1. Post operative pain score (Numerical rating scale) for pain at 30 minutes, 1 hour, 4 hours, 8 hours, and 24 hours. 2. Post operative sedation score (Ramsay sedation scores) for sedation at 30 minutes, 1 hour, 4 hour, 8 hour, and 24 hour. 3. Postoperative haemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate) at 30 minutes, 1 hour, 4 hour, 8 hour, and 24 hour. 4. Total rescue analgesic requirement in first 24 hour postoperatively. 5. Incidence of PONV in first 24 hour postoperatively. In both the groups
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