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CTRI Number  CTRI/2020/06/025817 [Registered on: 11/06/2020] Trial Registered Prospectively
Last Modified On: 30/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of trans-tracheal injection of local anaesthetic on post-operative sore-throat in patients undergoing breast cancer surgeries- 
Scientific Title of Study   Effect of trans-tracheal injection of local anaesthetic on the incidence of post-operative sore-throat in patients undergoing breast cancer surgeries- A Randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitu PV 
Designation  Associate Professor 
Affiliation  Amrita Institute of medical Sciences 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences

Ernakulam
KERALA
682041
India 
Phone  09495962020  
Fax  2802020  
Email  nituveesundeep@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nitu PV 
Designation  Associate Professor 
Affiliation  Amrita Institute of medical Sciences 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences


KERALA
682041
India 
Phone  09495962020  
Fax  2802020  
Email  nituveesundeep@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nitu PV 
Designation  Associate Professor 
Affiliation  Amrita Institute of medical Sciences 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences


KERALA
682041
India 
Phone  09495962020  
Fax  2802020  
Email  nituveesundeep@gmail.com  
 
Source of Monetary or Material Support  
Amrita Institute of Medical Sciences, AIMS Ponekkara, Kochi-682041 
 
Primary Sponsor  
Name  Amrita Institute of Medical Sciences 
Address  AIMS Ponnekkara, Kochi-682041 
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 
Nitu PV  Amrita Institute of medical Sciences  Department of Anaesthesia, Breast clinic OT
Ernakulam
KERALA 
09495962020
2802020
nituveesundeep@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo group  control group patients will receive trans-tracheal injection of 5ml of 0.9% saline.  
Intervention  Transtracheal local anaesthetic group  Patients will receive trans-tracheal injection of 5ml of 4% lignocaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Patients aged 18–60 years, of the American Society of Anaesthesiologists (ASA) physical status 1–2, undergoing breast cancer surgeries lasting 2-3h under general anaesthesia with laryngeal mask airway  
 
ExclusionCriteria 
Details  Patients with an anticipated difficult airway, history of allergy to the test drug, who required more than one attempt at insertion and those with pre-operative sore throat or already on analgesics or steroids (systemic or inhaled)  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary objective is to assess the reduction in incidence and severity of postoperative sore throat.  Post operative period upto 24 h 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objectives include reduction in incidence of postoperative hoarseness of voice and cough.   Post operative period upto 24 h 
 
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   Phase 3 
Date of First Enrollment (India)   15/06/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  



Breast surgeries are commonly performed under general anaesthesia with laryngeal mask airway. Post operatively sore-throat (POST), hoarseness and cough are common complaints following breast surgery. Even though these symptoms resolve spontaneously, prophylactic management of POST is recommended to improve the quality of post-anaesthesia care.  Various drugs like intravenous dexamethasone, ketamine, magnesium sulphate have been studied for their efficacy to reduce the incidence of sore-throat. Nebulization or local application of local anaesthetic has been used to reduce the development of POST [1]. Trans- tracheal administration of local anaesthetic is used in awake fiberoptic intubation.[2] This study is performed to assess the effectiveness of single dose 5ml of  trans-tracheal lignocaine 4% on the incidence of POST, hoarseness and cough.

Methods

This prospective, randomised, double blinded study will be conducted after obtaining approval from hospital ethical committee, clinical trial registry of India (CTRI)  and informed written consent from patients.  Patients aged 18–60 years, of the American Society of Anaesthesiologists (ASA) physical status 1–2, undergoing breast cancer surgeries lasting 2-3h under general anaesthesia with laryngeal mask airway will be included in this study. Patients with anticipated difficult airway, history of allergy to the test drug, who required more than one attempt  at insertion and those with pre-operative sore throat or already on analgesics or steroids (systemic or inhaled) will be excluded from the study.

The patients will be randomly assigned into two equal groups, T and S, based on computer-generated random sequence of numbers. Concealment will be achieved by closed envelope technique. Standard general anaesthesia protocol will be followed in both groups. Patients will receive oral ranitidine 150 mg, metoclopramide10 mg, and alprazolam 0.25 mg on the night before surgery and ranitidine 150 mg and metoclopramide 10 mg on the morning of

surgery.

In the operation theatre, intravenous (IV) cannula will be inserted and monitoring with electrocardiography, noninvasive blood pressure monitor, and pulse oximeter will be done. Patients in group T will receive a trans-tracheal injection of 5ml of 4% lignocaine and group S will receive a trans-tracheal injection of 5ml of 0.9% saline. Patients will be pre oxygenated with 100% O2; glycopyrrolate 0.2 mg, midazolam 2 mg and fentanyl 2 µg/kg will be given intravenously.  They will then be induced with IV propofol 1.5–2.5 mg/kg till there is loss of response to verbal command and the patient becomes apnoeic. Classic LMA size 3/4 will be inserted after full deflation. The patient will be maintained on O2, N2O and isoflurane 0.5%–1.5%. LMA cuffs will be filled with 20/30 ml of room air. If >1attempt will be required for insertion, the patients will be excluded from the study.

The trans-tracheal injection will be given by a single consultant anaesthetist. The cuff pressure will be measured and will be set to 25 cmH2O using Portex cuff inflator (manufacturer: Smiths Medical International Ltd., UK) in both groups. Patients will be maintained on spontaneous ventilation. Rise in heart rate and/or mean arterial pressure more than 20% from the baseline value will be initially treated with increasing the inspired concentration of isoflurane to 1.5%–2%. If there was no response, IV 20 μg boluses of fentanyl will be given. Toward the end of the surgery, IV ondansetron 4 mg and IV paracetamol 1 g will be given to all patients. On completion of the surgery, LMA will be removed after suctioning and deflating the cuff. Four hours after surgery all patients will receive oral paracetamol 650 mg 8th hourly. Patients will be given rescue analgesia with IV tramadol 1mg.kg−1 if the patient complained of pain. The total dose of tramadol given in the first 24 h will be noted for both groups. Postoperative sore throat, cough and hoarseness will be monitored  by the anaesthetist who will be blinded and the responses will be noted at 0, 2, 4, 12, and 24 h.



 
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