| CTRI Number |
CTRI/2018/10/016018 [Registered on: 15/10/2018] Trial Registered Retrospectively |
| Last Modified On: |
03/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Bilateral superficial cervical plexus block for post-operative analgesia in thyroid surgeries using ropivacaine(0.2%) with or without dexmedetomidine |
|
Scientific Title of Study
|
A prospective, double blind, randomised control study on bilateral superficial cervical plexus block using ropivacaine (0.2%) with and without dexmedetomidine (1mcg/kg)for post-operative analgesia in thyroid surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva Aseri |
| Designation |
PG student |
| Affiliation |
RNT Medical College,Udaipur |
| Address |
Pavitra kunj,New light colony,near bus stand,bilara , jodhpur Rajasthan
Department of Anaesthesia
RNT Medical College,
Udaipur
Udaipur
RAJASTHAN
342602
India |
| Phone |
9460662200 |
| Fax |
|
| Email |
aseriapoorva91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrLalit Kumar Raiger |
| Designation |
Professor |
| Affiliation |
RNT Medical College,Udaipur |
| Address |
12 Rudra vihar, near sun tower, Keshav nagar,
Department of Anaesthesia
RNT Medical College,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414352823 |
| Fax |
|
| Email |
drlalitkumar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrLalit Kumar Raiger |
| Designation |
Professor |
| Affiliation |
RNT Medical College,Udaipur |
| Address |
12 Rudra vihar, near sun tower, Keshav nagar,
Department of Anaesthesia
RNT Medical College,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414352823 |
| Fax |
|
| Email |
drlalitkumar@hotmail.com |
|
|
Source of Monetary or Material Support
|
| RNT medical college,
Maharana Bhupal Hospital,
Near court circle,Udaipur
Rajasthan |
|
|
Primary Sponsor
|
| Name |
MB hospital Udaipur |
| Address |
MB Hospital udaipur rajasthan |
| Type of Sponsor |
Government 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 |
| Apoorva Aseri |
Maharana Bhupal Hospital udaipur rajasthan |
Rnt Medical college campus
Near court circle
Udaipur
Udaipur
RAJASTHAN |
9460662200
aseriapoorva91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT Medical College and Controller and attached hospitals Udaipur Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, (2) ICD-10 Condition: E079||Disorder of thyroid, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bilateral superficial cervical plexus block |
for post-operative analgesia in thyroid surgeries |
| Comparator Agent |
dexmedetomidine |
bilateral superficial cervical plexus block using ropivacaine (0.2%) with and without dexmedetomidine (1mcg/kg)for post-operative analgesia in thyroid surgeries |
| Comparator Agent |
ropivacaine (0.2%) |
bilateral superficial cervical plexus block using ropivacaine (0.2%) with and without dexmedetomidine (1mcg/kg)for post-operative analgesia in thyroid surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
the study conducted on 60 patients of ASA Grade I & II of either sex, aged 18 to 60 years, having a euthyroid state, who undergone elective thyroid surgeries under general anesthesia and after completion of surgery bilateral superficial cervical plexus block given. |
|
| ExclusionCriteria |
| Details |
patient refusal,age <18yrs, ASA grade >2,patient havong severe respiratory,cardiac or renal disorders,and acute psychiatric illness,infection at the injection site,allergy to agent used,morbid obesity (bmi>35),coagulation disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative analgesia.
To determine the adverse effects, if any of ropivacaine and dexmedetomidine.
To study the post-operative pain management, rescue analgesic requirement, sedation in patients, hospital stay and patient comfort.
|
to study post-operative analgesia at 0hour,4hour,8hour,12hour and 24hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the post-operative pain management, rescue analgesic requirement, sedation in patients, hospital stay and patient comfort. |
to study post-operative analgesia at 0hour,4hour,8hour,12hour and 24hour |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/05/2018 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the effects of dexmedetomidine (1mcg/kg), adding to ropivacaine(0.2%)in bilateral superficial cervical plexus block in thyroid surgery regarding effect on : Postoperative analgesia. To determine the adverse effects, if any of ropivacaine and dexmedetomidine. To study the post-operative pain management, rescue analgesic requirement, sedation in patients, hospital stay and patient comfort. |