| CTRI Number |
CTRI/2024/06/069242 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relief injections by using ultrasound machine to nerve groups in neck for thyroid removal surgeries for continuous pain relief even after surgery. |
|
Scientific Title of Study
|
A Randomized Comparative Double Blinded Study of Postoperative Analgesic efficacy of 0.25 percent ropivacaine with Dexmedetomidine versus 0.25 percent ropivacaine with dexamethasone in ultrasound guided bilateral superficial cervical plexus block for thyroidectomy patients |
| 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 Kavselyaa Rai V |
| Designation |
Post Graduate student in Department of Anesthesiology Vijayanagar institute of medical sciences |
| Affiliation |
Vijayanagar Institute of medical sciences, Rajiv Gandhi University of medical sciences |
| Address |
Post Graduate
Department of Anaesthesiology
Vijayanagar institute of medical sciences
Bellary KARNATAKA 583104 India |
| Phone |
9790120371 |
| Fax |
|
| Email |
vkavsirai1800@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kavselyaa Rai V |
| Designation |
Post Graduate in Department of Anesthesiology |
| Affiliation |
Vijayanagar institute of medical sciences, Rajiv Gandhi University of medical sciences |
| Address |
Post Graduate
Department of Anesthesiology
Vijayanagar institute of medical sciences,
Cantonment,
Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9790120371 |
| Fax |
|
| Email |
vkavsirai1800@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Raghunath S S |
| Designation |
Associate Professor in Department of Anesthesiology |
| Affiliation |
Vijayanagar institute of medical sciences, Rajiv Gandhi University of medical sciences |
| Address |
Department of Anesthesiology,
Vijayanagar institute of medical sciences
Bellary KARNATAKA 583104 India |
| Phone |
9945434495 |
| Fax |
|
| Email |
docraghu2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar institute of medical sciences,
Ballari 583104
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of medical sciences |
| Address |
Department of Anesthesiology
Cantonment
Ballari
Karnataka
583104
Karnataka
India
|
| 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 |
| Dr Kavselyaa Rai V |
Vijayanagar institute of medical sciences |
Department of Anesthesiology,
Major OT Complex, Cantonment Bellary KARNATAKA |
9790120371
vkavsirai1800@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Vijayanagar Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
0.25% ropivacaine added with dexamethasone 0.05mg/kg diluted to 1 ml and under Ultrasound guidance, superficial cervical plexus is identified and given and post operative analgesic is observed at baseline followed by every 30 minutes till 24 hours |
| Intervention |
Dexmedetomidine |
0.25% ropivacaine added with dexmedetomidine 1mcg/kg under Ultrasound guidance, superficial cervical plexus is identified and given and post operative analgesic is observed at baseline followed by every 30 minutes till 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Normal cardiopulmonary status
Patients with euthyroid status
ASA I , II |
|
| ExclusionCriteria |
| Details |
Refusing to be a part of study
Allergy of Drug
Neural disorder
Substernal goitre
Bleeding, Hypertension, Diabetes
Recent steroid or opioid usage
Stridor
Infection at local site
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia with 0.25% ropivacaine with dexmedetomidine and dexamethasone |
0 time at 9.00am every 30 minutes for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rescue Analgesic Requirement in the first 24 post operative hours
Measure postoerative pain assessment by NRS scoring |
0 time at 9.00Am every 30 minutes for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
30/06/2024 |
| 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="0" 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 associated with moderate incisional pain, burning sensation, uneasiness in swallowing and post-operative nausea vomiting (PONV) attributable to endotracheal intubation, tissue dissection, and hyperextension during surgery. Cervical plexus blocks can be performed in patients undergoing thyroid surgery and prolonged postoperative analgesia can be provided by administering local anaesthetic solutions with or without adjuvant. It has been reported that up to 90% of patients require narcotic analgesics during the first postoperative day. BSCPB is a procedure with a low serious complication rate. The risks of phrenic nerve palsy and total spinal anaesthesia from injection into a dural cuff are restricted to blockade of the deep cervical plexus only; diffusion of local anaesthetic is not sufficient to account for these phenomena with a superficial technique Local anaesthetics, when used alone, offer a short duration of analgesia. Therefore, various adjuvants have been studied, including dexmedetomidine, an α2 agonist, which provides stable haemodynamics, and prolonged analgesia with minimal side effects and Dexamethasone, a corticosteroid, is a recent addition to the list with promising results in BSCPB. We will be investigating the effects of dexmedetomidine and dexamethasone as adjuvants with ropivacaine on the duration of analgesia as a primary outcome and NRS, rescue analgesic requirement, haemodynamic parameters, PONV, and adverse events as secondary outcomes in BSCPB for thyroidectomy under general anaesthesia
Patients of ASA I and II of either sex posted for elective thyroidectomy under general anesthesia, will be randomly assigned to each group (A and B). After obtaining written informed consent, participants will be randomized to receive bilateral SCPB with Group A will be receiving ropivacaine 0.25% with dexmedetomidine 1mcg/kg and Group B will be receiving ropivacaine 0.25% with dexamethasone 0.05mg/kg 1ml. To reduce subjective and objective bias, the study will be double-blinded so that the anaesthesiologist doing the procedure, the patient, and the monitoring personnel will be not aware of group allocation i.e., the mixture used for the BSCPB. The syringe will be labelled with a number, and a record of the syringe’s contents will be preserved. Patients in this trial will be evaluated by taking detailed history, airway assessment, and routine investigations along with thyroid function tests. All standard ASA monitors connected and baseline vitals will be recorded. Patients will be given intravenous midazolam 0.02 mg/kg and fentanyl 2µg/kg as premedication along with preoxygenation with 100% oxygen. Propofol 2 mg/kg and vecuronium 0.1 mg/kg will be used for inducing general anaesthesia, which will be followed by tracheal intubation. Anaesthesia will be maintained with inhalational agent sevoflurane (MAC 0.7–1.3) in a mixture of O2 :N2 O in a ratio of 50:50. The block is normally performed in supine position with the patients head turned to the contra-lateral side. Once the skin is cleaned and prepared with antiseptic, the transducer is placed over the lateral side of the neck at the midpoint of the posterior border of the sternocleidomastoid muscle (SCM).The patients will undergo ultrasound evaluation with SONOSITE (linear probe- 5-12 MHz). The transducer is positioned such that the tapering end (posterior border on the ultrasound image) of the SCM is in the centre of the screen . The needle is then introduced from the posterior aspect through the skin and platysma and 5-10 ml of LA deposited just behind this landmark. This will involve two injections, starting from mid-point of SCM, one from caudal to cranial end and the second one from cranial to caudal end. Duration of Postoperative analgesia: The time between the onset of block and the first rescue analgesia i.e., NRS more than or equal to 4. Rescue Analgesia: Injection Tramadol 1mg/kg. Side effects- PONV, Shivering will be assessed. Sedation score is assessed by Modified Ramsay Sedation score |