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CTRI Number  CTRI/2024/07/070922 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 16/12/2024
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   Effectiveness of superficial cervical plexus block as adjuvant to General anesthesia in reconstructive commando surgery  
Scientific Title of Study   Effectiveness of superficial cervical plexus block as adjuvant to General anesthesia in reconstructive commando surgery  
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 POOJA SHARMA 
Designation  Resident doctor Department of Anaesthesia  
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  Room no 1 Department of Anaesthesiology RIICO Institutional Area Sitapura Tonk Road Jaipur Rajasthan JAIPUR

Jaipur
RAJASTHAN
302022
India 
Phone  9783466888  
Fax  01412770677  
Email  docpoojasharma23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Namita Gupta 
Designation  Associate Professor Department of Anaesthesia 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  Room no 2 Department of Anaesthesia pain management and critical care RIICO Institutional Area Sitapura Jaipur Rajasthan Tonk Road JAIPUR

Jaipur
RAJASTHAN
302022
India 
Phone  9462083676  
Fax  01412770677  
Email  drnamita2007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Namita Gupta 
Designation  Associate Professor Department of Anaesthesia 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  Room no 2 Department of Anaesthesia pain management and critical care RIICO Institutional Area Sitapura Jaipur Rajasthan Tonk Road JAIPUR

Jaipur
RAJASTHAN
302022
India 
Phone  9462083676  
Fax  01412770677  
Email  drnamita2007@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Hospital 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Hospital  
Address  RIICO Institutional Area Sitapura Tonk Road Jaipur Rajasthan 302022  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR POOJA SHARMA  OT Complex and ICU Mahatma Gandhi Medical College and Hospital   Department of Anaesthesiology RIICO Institutional Area Sitapura Tonk Road
Jaipur
RAJASTHAN 
9783466888
01412770677
docpoojasharma23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Mahatma Gandhi College of Medical Sciences and Technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effectiveness of superficial cervical plexus block as adjuvant to General anaesthesia in reconstructive commando surgery  This group will be block group (superficial cervical plexus block with 0.5%levobupvicaine 10 ml with 0.5%levobupvicaine 5ml for inferior alveolar nerve block and will be administered with general anaesthesia & monitor for hemodynamic parameters for 420 minutes 
Comparator Agent  Effectiveness of superficial cervical plexus block as adjuvant to General anaesthesia in reconstructive commando surgery  This group will be the control group and will be administered with general anaesthesia alone and will be monitored for haemodynamic parameters for 420 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA grade II III AND IV
Patient undergoing head & neck cancer surgery
Giving written informed consent for the study
 
 
ExclusionCriteria 
Details  Patient with preexisting cardiac disease
Uncontrolled Hypertension and Diabetes
Asthma
Severe renal or hepatic dysfunction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe attenuation of stress response by assessing hemodynamic variation  Days of stay in hospital
Early recovery after Surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on graft viability, re exploration rate ,recovery profile and length of stay in I.C.U and hospital.

 
Aims to observe patient recovery and parameters capillary refill time chances of re-expolaration and hospital stay/icu stay.
 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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 3 
Date of First Enrollment (India)   27/07/2024 
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
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The superficial cervical plexus block (SCPB) is a simple and easy to perform technique which is well elicited for Regional anesthesia of the peri mandibular region It is a potentially valuable anesthetic technique for patient to be operated  with conditions such as ear lobe laceration  submandibular abscesses  injuries to the mandibular region or and neck  thyroid surgeries(superficial neck surgeries),carotid endarterectomy. 

Heidenhein launched the lateral approach technique and labat popularized it in the USA.

 Regional anesthesia is incomparably the best-established procedure  offering stress free anesthesia  as its simple technique, lower catecholamine release, decreased blood loss due to local vasoconstrictors and sympathetic blockade and negligible morbidity rates with appropriate dosages of the local anesthetic .

Oral surgical and dental procedures are routinely performed in an outpatient setting.

 Many techniques can be  employed to achieve anesthesia of the dentition and surrounding hard and soft tissues of the maxilla and mandible. 

 The superficial cervical plexus (CP) has its origins from the ventral rami of the nerve roots C2 to C4.
These  nerve roots provide sensation to the skin and superficial structures of the ear auricle,acromioclavicular joint and anterolateral neck.
These branches exit at a midpoint along the posterior border of the sternocleidomastoid muscle at the same level as the thyroid cartilage notch.
These roots combine to form the four terminal branches  (1)  lesser occipital  (2) greater auricular (3) transverse cervical (4) supraclavicular nerves.
They emerge from behind the posterior border of the SCM.
Anaesthesia will be maintained using 50% o2 with air; and isoflurane (1.2- 1.5 vol %). Duration of surgery will be      defined as the time from surgical incision till closure of the wound. The following variables (SBP, DBP, MAP, HR, SPO2)  would be recorded just before medications (baseline), after SCPB,  after induction,   and 1 min, 5 min, 10min,  15min and 30min 60 min and 90 min  after intubation and than hourly till the completion of surgery in both the groups
 
Injection Dexmedetomidine 1ug/kg i.v bolus  slowly within 30 minutes followed by intravenous infusion @0.2-0.5ug/kg/hr for maintanace of hemodynamic. Adverse effects such as  bradycardia,  hypotension, respiratory depression, headache, nausea, vomiting or restlessness would  be noted. 
Hypertension will be defined as SBP >30% of baseline value or > 140 mmhg and hypotension defined as a decrease in the systolic arterial pressure 30% from baseline values. Similarly tachycardia and bradycardia defined as variations in hr 30% from baseline values. patient shifted to icu, intubated, sedated , paralysed Serum lactate level would be monitoring just pre induction and before extubation.
.
Following parameters will be noted capillary refill time, chances of re-expolaration and   hospital stay/icu stay.

A Prospective hospital based  observational study including all cases  in a time period between April 2023 to October 2024.  
Data will be collected by using self design questionnaire.
Entire data would be entered into a Microsoft office software and appropriate statistical test will be applied and results will be calculated.



 
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