| CTRI Number |
CTRI/2019/09/021335 [Registered on: 19/09/2019] Trial Registered Prospectively |
| Last Modified On: |
08/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of thyroidectomy surgery under USG guided local nerve block |
|
Scientific Title of Study
|
Prospective observational study of thyroidectomy under USG guided bilateral superficial cervical plexus block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Kumar Kannaujia |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate institute of medical sciences |
| Address |
Deptt of anaesthesia, 1st floor ,A block
Sanjay Gandhi Post Graduate institute of medical sciences, Lucknow ,UTTAR PRADESH
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974042 |
| Fax |
|
| Email |
ashishkannaujia77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Kumar Kannaujia |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate institute of medical sciences |
| Address |
Deptt of Anaesthesia,1st Floor, A Block Sanjay Gandhi Post Graduate institute of medical sciences, Lucknow ,Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974042 |
| Fax |
|
| Email |
ashishkannaujia77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashutosh Chaurasia |
| Designation |
Junior Resident |
| Affiliation |
Sanjay Gandhi Post Graduate institute of medical sciences |
| Address |
Junior Resident (2nd year),1st floor,A - Block, Anaesthesia department, Sanjay Gandhi Post Graduate institute of medical sciences,
Rai barely road,Habibut Mau Mawaiya ,Lucknow ,Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9582926702 |
| Fax |
|
| Email |
ashutosh8081@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate institute of medical sciences,Raebareli Road, Haibat Mau Mawaiya, Lucknow, Uttar Pradesh 226014 |
|
|
Primary Sponsor
|
| Name |
sanjay gandhi post graduate institute of medical sciences lucknow |
| Address |
Raibarely road lucknow 226014 |
| 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 |
| Ashish Kumar Kannaujia |
Sanjay Gandhi Post Graduate Institute of medical sciences |
Department of Anaesthesiology 1st Floor,A Block ,Sanjay Gandhi Post Graduate institute of medical sciences , Raibarely road, Lucknow
Lucknow
UTTAR PRADESH |
8765974042
ashishkannaujia77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Sanjay Gandhi Post graduate institute of medical sciences, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E040||Nontoxic diffuse goiter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 & 2 patients
2.Age 18-65 years (male &female )
3.Small goitre (upto 4x4cm)
|
|
| ExclusionCriteria |
| Details |
1.Patient Refusal
2.ASA 3 & 4 patients
3.Not cooperative and not able to understand instructions,communication barrier (dementia, language barrier, mental retardation)
4.Allergy to LA
5.Proven compromise in IDL in Vocal cords
6.Obese
7. H/o OSA, dyspnoea, tracheal deviation/ compression on neck X-ray
8.Recurrent goitre
9.Renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation of anesthetic efficacy of US guided cervical plexus block block for thyroidectomy |
every 5 minutes for first half hour and then every 15 minutes till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intra op and post op analgesic requirement |
0 6 12 24 hrs after surgery |
| block related complications |
0 6 12 24 hrs after surgery |
| patient satisfaction score |
24 hours after surgery |
| surgeon satisfaction score |
24 hours after surgery |
| hospital stay duration |
once at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/10/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Traditionally general anesthesia is used for head and neck surgeries, including thyroidectomy /hemithyroidectomy/parathyroidectomy. However nowadays there is resurgence of regional anesthesia in form of superficial cervical plexus block( SCPB). It has various advantage over GA in form of no cardiovascular depression ,lesser post op depression, & sedation ,less PONV, no respiratory complications, no interference with bowel function, early recovery and discharge,decreased cost of treatment etc.Traditionally this block is given by landmark technique which has its own limitation and complication in form of injury to vascular structures ,intraneural injection phrenic nerve paralysis etc.these complications can be minimised by giving the block under guidance of ultrasound. Our primary objective will be evaluation of anesthetic efficacy of US guided cervical plexus block for thyroidectomy/parathyroidectomy. Secondary objective will be intra op and post op analgesic requirement, patient & surgeon satisfaction score, block related complications, & hospital stay duration. It will be a prospective observational study over a period of next 1 year.Standard ASA monitoring will be done.Bilateral superficial cervical plexus block will be given with 10 ml of bupivacaine 0.25 % with 22 G 2.5 inch needle.Effect of block will be assessed after 5 mins by pin prick test and reassessed again. After successful block surgeon will start surgery.In case of failed block patient will be given GA. For pain intraop we will be using fentanyl. In post op we will be using paracetamol and tramadol for rescue analgesia. Amount of Analgesic requirement will be noted.Post operative pain will be assessed on VAS scale at 0, 6 12 24 hours.Surgeon and patient satisfaction score will be asssessed alongwith duration of hospital stay and complications. |