| CTRI Number |
CTRI/2024/02/062922 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of bilateral superficial cervical plexus block versus local wound infiltration using a bupivacaine dexamethasone mixture |
|
Scientific Title of Study
|
Comparative Study of Analgesic Efficacy of Preoperative Bilateral Superficial Cervical Plexus Block with that of Simple Wound Infiltration with Bupivacaine Dexamethasone Mixture for Thyroidectomies - A Prospective Blinded Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini H |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari Medical College and Hospital |
| Address |
Department of Anaesthesia, Rajarajeshwari Medical College and Hospital, Bengaluru
Bangalore KARNATAKA 560074 India |
| Phone |
8971265579 |
| Fax |
|
| Email |
ashwinih@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ashwini H |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari Medical College and Hospital |
| Address |
Department of Anaesthesia, Rajarajeshwari Medical College and Hospital, Bengaluru
KARNATAKA 560074 India |
| Phone |
8971265579 |
| Fax |
|
| Email |
ashwinih@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Ashwini H |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari Medical College and Hospital |
| Address |
Department of Anaesthesia, Rajarajeshwari Medical College and Hospital, Bengaluru
KARNATAKA 560074 India |
| Phone |
8971265579 |
| Fax |
|
| Email |
ashwinih@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeshwari Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Aditya Kheny |
| Address |
Department of Anaesthesia, Rajarajeshwari Medical College and Hospital |
| 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 Aditya Kheny |
Rajarajeshwari Medical College and Hospital |
Department of Anaesthesia, Rajarajshwari Medical College and Hospital Bangalore KARNATAKA |
9483149909
khenyaditya97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E012||Iodine-deficiency related (endemic) goiter, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Superficial Cervical Plexus Block |
Patients undergoing thyroidectomies will be into group A. Group A will receive Bilateral Superficial Cervical Plexus Block with 8ml of 0.25% Bupivacaine and 2mg dexamethasone on each side. Analgesic efficacy is compared between both groups. Total analgesic consumption in 24 hours is studied.
Dose - 8ml of 0.25% Bupivacaine and 2mg Dexamethasone on each side
Route of administration - Bilateral Superficial Cervical Plexus Block under USG guidance
Total duration - 12 to 14 hours |
| Comparator Agent |
Local Wound Infiltration |
Patients undergoing thyroidectomies will be into group B. Group B will receive Local Wound Infiltration with 10ml of 0.25% bupivacaine with 4mg dexamethasone before skin incision. Analgesic efficacy is compared between both groups. Total analgesic consumption in 24 hours is studied
Dose - 10ml of 0.25% bupivacaine with 4mg dexamethasone
Route of Administration - Local wound infiltration
Duration - 4 to 6 hours |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I to III patients posted for thyroidectomies
2. Aged between 20 to 60 years. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with history or allergy to local anaesthetics
3. Mentally retarded patients
4. Local infection at the site of procedure
5. Patients with history of chronic analgesic use
6. Patients with huge thyroid swellings
7. Patients with malignant thyroid swellings |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy of superficial cervical plexus block with that of local wound infiltration.
To compare the duration of action of superficial cervical plexus block with that of local wound infiltration. |
Vitals will recorded every 5 mins for the first 20 mins and then every 30 mins till the end of the surgery. Postoperatively, pain assessment will be done using Visual Analog Scale (VAS) at 1 hour after
extubation, 2nd hour, 3rd hour, 6th hour, 12th hour, 24th hour.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe for any postoperative complications.
Total analgesic consumption in 24 hours. |
First 24 hours monitoring |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| 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
|
Pain after thyroid surgeries is considered to be of moderate intensity and short duration. Patient may experience sore throat, odynophagia, burning sensation in the throat, nausea and vomiting which may be cause by the surgical procedure or due to endotracheal tube. Usually, multimodal analgesia is tried for post operative patients. Non-steroidal anti-inflammatory drugs (NSAIDs) may not be effective for postoperative pain and opioids cause post operative nausea and vomiting. So, recent studies concerning post thyroidectomy analgesia are focused on the efficacy of regional techniques. Local anaesthetic wound infiltration (LWI), bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus blocks are tried with variable results. All these methods share the same principal of cervical plexus sensory blockade at different levels. LWI is a simple method of post operative pain management, because of its simplicity, safety and low cost. Its efficacy in decreasing post operative pain and analgesic consumption is demonstrated in many procedures like cholecystectomy, hysterectomy and hernia repair. BSCPB is a popular regional anaesthesia used in thyroidectomy because of its feasibility and efficacy. Use of ultrasound guidance (US) facilitates the procedure by real-time visualisation of anatomical structures and needle movements and increases the chances of successful blockade while decreasing the rate of complications. So, in this study, we are planning to compare the effectiveness of US guided BSCPB with that of LWI using bupivacaine dexamethasone mixture for post operative analgesia following thyroidectomies. In our study an effort has been made to compare analgesic efficacy and duration of analgesia of superficial cervical plexus block with that of local wound infiltration. |