| 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
|
|
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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
|
|
|
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.
|
|
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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. |