| CTRI Number |
CTRI/2024/05/066752 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the intervention of post operative pain for two drugs as a additive in ultrasound guided neck block among participants |
|
Scientific Title of Study
|
Comparison of post operative analgesic efficacy of dexmedetomidine versus dexamethasone as an adjuvant in ultrasound guided bilateral superficial cervical block for thyroid surgeries-A randomised control 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 |
Vasanthi V |
| Designation |
Post graduate |
| Affiliation |
Pondicherry university |
| Address |
Room number 109 First floor Department of anesthesiology Sri manakula vinayagar medical college and hospital kalitheerthalkuppam madagadipet
605107
India
Room number 109 First floor Department of anesthesiology Sri manakula vinayagar medical college and hospital kalitheerthalkuppam madagadipet
605107
India
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9952362851 |
| Fax |
|
| Email |
vasanthi.vijay12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dilip Chandar D |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Sri manakula vinayagar medical college and hospital
Room no107
First floor
kalitheerthalkuppam
madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dilip Chandar D |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Sri manakula vinayagar medical college and hospital
Room no 107
First floor
kalitheerthalkuppam
madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 109 First floor Department of anesthesiology Sri manakula vinayagar medical college and hospital kalitheerthalkuppam madagadipet
605107
India |
|
|
Primary Sponsor
|
| Name |
Vasanthi V |
| Address |
Room number 107
First floor
Sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet |
| 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 |
| Vasanthi V |
Sri manakula vinayagar medical college and hospital |
Room number 107
First floor
Sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
Pondicherry
PONDICHERRY |
9952362851
vasanthi.vijay12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ETHICS COMMITTEE |
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: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone 8mg |
post operative analgesia after using as an adjuvant with 0.5% bupivacaine 5ml every one hour |
| Intervention |
Dexmeditomidine 50mcgs |
Post operative analgesia after using as an adjuvant with 0.5% bupivacaine 5ml for 24 hours will be monitored every one hour |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled toundergo elective thyroid surgeries under general anesthesia.
2. Patients of ASA physical status I & 1. 3. Patients of either sex aged 16 to 60 years. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the adjuvant effect of duration of post op analgesia with DEXMEDETOMIDINE (group A)versus DEXAMETHASONE(group B) when added with 0.2% ropivacaine in terms of total duration of analgesia. |
To assess the pain by VAS score post operatively every hour for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the intraoperative hemodynamic parameters between two groups |
To assess the hemodynamic parameter intra operatively by measurement of heart rate and blood pressure for every 5mins for 3hours |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/05/2024 |
| 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="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
|
Thyroidectomy is the commonest endocrine surgical procedure being carried out throughout the
globe.Majority of these patients have deranged thyroid functions and
sometimes may have even malignant changes in the thyroid gland’ The
commonest implications during such procedures involve the management of a potential difficult airway, especially in cases of retrosternal
goiter, and an enlarged thyroid gland compressing over the trachea for a
prolonged duration. Cardiac complications are equally challenging as
also the presence of various comorbidities which make the task of
anaesthesiologist extremely difficult.The
complexity of surgical intervention also adds to these existing
challenges as the procedure may vary from simple excision of a thyroid
nodule to removal of a large gland which may have a retrosternal
extension. Moreover, there always exists a potential risk of
uncontrolled hemorrhage from a vascular injury as the major vessels lie
in the vicinity of thyroid gland and sometimes from the injury to the
thyroid vessels itself.Thyroidectomy causes
postoperative pain and patient discomfort. Bilateral superficial
cervical plexus block is a regional anesthesia technique that can
provide analgesia during and after surgery.
The purpose of the study is to compare the characteristics and side effects following bilateral superficial cervical plexus block with ropivacaine supplemented with either dexmedetomidine or dexamethasone in patients scheduled for elective thyroidectomy surgeries. |