FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/06/019675 [Registered on: 14/06/2019] Trial Registered Prospectively
Last Modified On: 12/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Pain after radiation treatment for cancer cervix 
Scientific Title of Study   A prospective observational study of post-procedural pain in women undergoing intracavitary brachytherapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Ranganathan 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Room No 210, Main Building, Tata Memorial Hospital, Ernest Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  drpriyaranganathan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shilpa Awaskar 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Room No 210, Main Building, Tata Memorial Hospital, Ernest Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  shilpawaskar22@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shilpa Awaskar 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Room No 210, Main Building, Tata Memorial Hospital, Ernest Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  shilpawaskar22@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Ernest Borges Road, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  No funding 
Address  Not applicable 
Type of Sponsor  Other [Nil] 
 
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 
Priya Ranganathan  Tata Memorial Hospital  Room No 210, Main Building, Ernest Borges Road Parel Mumbai
Mumbai
MAHARASHTRA 
022-24177000
022-24146937
drpriyaranganathan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital IEC 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Female 
Details  Adult females (more than 18 years)
ASA 1,2,3
Cervical cancer patients undergoing intra-cavitary brachytherapy applications 
 
ExclusionCriteria 
Details  Refusal of consent
Cognitive dysfunction or psychiatric illness
Procedures other than standard ICA (e.g., implants or examination under anaesthesia) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain score on numerical rating scale of 0 to 10  30 minutes, 1 hour and 2 hours after completion of brachytherapy procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Need for rescue analgesia  within 2 hours after brachytherapy procedure 
To compare pain scores between patients having first brachytherapy versus subsequent brachytherapies  within 2 hours after procedure 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   17/06/2019 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cervical cancer is the second most common oncological morbidity in women in India after

breast cancer.Patients undergo various treatment modalities including surgery,

chemotherapy and radiation therapy which includes external beam radiation therapy and

brachytherapy. Locally advanced cervical cancer (LACC) constitutes approximately 70% of all the

cervical cancers for which the definitive treatment is chemo-radiation. Radical radiation therapy,

including brachytherapy, forms the mainstay of treatment in LACC. Brachytherapy involves radiation

treatment by placing the radioactive sources into the utero-cervico-vaginal cavity for cervical

cancers. The procedure involves insertion of an intra-cavitary applicator (ICA) under

anaesthesia and adequate analgesia. The steps include examination under anaesthesia, bladder

catheterization, dilatation of cervical canal, sounding of utero-cervical canal, placement of the

intra-cavitary brachytherapy applicator system and vaginal packing. The brachytherapy

applicator system has intrauterine tandem and intravaginal components in the form of ring or

ovoids, so that high doses of radiation are delivered to the cervix/ tumor while relatively

sparing neighbouring pelvic organs.

After recovery from the procedure, the patient receives parenteral analgesics and is transferred

for imaging, treatment planning and delivery. After brachytherapy completion, the applicators

are removed under adequate analgesia. Inadequate analgesia during the procedure may lead to

poor patient compliance, suboptimal evaluation, & applicator placement, inadequate vaginal

packing and inability to place the applicator which could adversely affect morbidity and local

control of disease. Various techniques for minimising discomfort during ICA placement

include general anaesthesia, regional anaesthesia (spinal, epidural, caudal and paracervical

blocks) and sedation with or without local anaesthesia. 

The current standard of care in our institute is to perform ICA placement under general

anaesthesia with systemic analgesics to address the post-procedure pain. Less than 5% of

patients may undergo the procedure under spinal anaesthesia, sedation and/or paracervical

block due to systemic factors which make them high-risk for general anaesthesia

The aim of this study is to observe the incidence and severity of post-procedure pain in patients

undergoing ICA procedures, and to look at the need of supplementary analgesics post

procedure and to compare the severity of pain in different groups of patients such as naive ICA

placements and consecutive ICA placements.

 
Close