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
|
|
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
|
|
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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