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CTRI Number  CTRI/2024/12/077619 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   A study to evaluate the frequency of pain in head and neck cancer patients until 6 months after surgery 
Scientific Title of Study   Incidence and severity of chronic pain and its impact on quality of life in patients undergoing major reconstructive head and neck cancer surgery: A Prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4543_Version 1.1 dated 16.09.24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vandana Agarwal  
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of anaesthesia critical care and pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr E Borges marg, Parel Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177042  
Fax    
Email  vandanachaukar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana Agarwal  
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of anaesthesia critical care and pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr E Borges marg, Parel Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177042  
Fax    
Email  vandanachaukar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pratik Kumar Shinde 
Designation  Post Graduate Student 
Affiliation  Tata Memorial Hospital 
Address  Department of anaesthesia critical care and pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr E Borges marg, Parel Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  8806439877  
Fax    
Email  pratikkumarshinde.ps@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Maharashtra- 400012  
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Dr Ernest Borges road, Parel East, Parel, Mumbai, Maharashtra, 400012 
Type of Sponsor  Research institution and hospital 
 
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 Vandana Agarwal   Tata Memorial Hospital  Department of Anaesthesia, Critical care and Pain, 2nd floor, OT complex and recovery area, Main Building, Tata Memorial Hospital, Dr E Borges marg, Parel Mumbai MAHARASHTRA.
Mumbai
MAHARASHTRA 
02224177042

vandanachaukar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital_Institutional Ethics Committee I  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, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adult more than 18 years of age patients undergoing head and neck surgery with free flap
reconstruction. 
 
ExclusionCriteria 
Details  Age less than 18 years
Pregnant and Lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence and severity of chronic postoperative pain in patients undergoing
free flap reconstruction for head and neck cancer. 
at 6 months post hospital discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Nature of pain (Somatic/neuropathic) based on patients’ description
Incidence of Neuropathic pain (Pain Detect score).
Postoperative quality of life from a pain perspective (based on Brief Pain Inventory) 
patients at discharge, and
3-months post hospital discharge
 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   16/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Introduction: 

Microvascular surgery has revolutionized the field of head and neck cancer reconstruction, offering patients the prospect of functional and aesthetic restoration following surgical resections. Among the array of available techniques, the radial artery forearm flap (FRAF), anterolateral thigh flap (ALT), and fibula osteocutaneous flap (FFOCF) have emerged as the foremost choices for reconstructive procedures. These free flaps offer versatility, reliability, and favourable outcomes, contributing to their widespread adoption as the cornerstone of contemporary reconstructive strategies.

The primary objectives of reconstructive surgery extend beyond mere anatomical restoration to encompass the restoration of critical functions such as speech and swallowing, pivotal for maintaining patients` overall quality of life. The remarkable success rates exceeding 95percent reported in numerous centres underscore the efficacy of free flap reconstruction in achieving these goals. (1-3) However, the multifactorial nature of postoperative quality of life necessitates understanding factors influencing patient outcomes beyond surgical success alone.

The influence of reconstruction type, surgical approach, cancer stage on postoperative quality of life cannot be overstated. (4) Complications such as primary and donor site morbidity and chronic postsurgical pain (CPSP) can significantly impact patients long-term well-being.

Recent studies have shed light on the prevalence and characteristics of donor site pain following reconstructive procedures, particularly with the anterolateral thigh flap (ALT). Shen et al (4), Townley et al. (5) and Weise et al. (6) have highlighted the persistence of pain and sensory disturbances at the donor site of ALT flap, emphasizing the need for thorough evaluation and proactive pain management strategies. Moreover, in a retrospective study, head and neck cancer pain has been linked to chronic opioid use, which in turn is associated with decreasing survival rates. (7) This finding underscores the intricate interplay between pain management, oncologic outcomes, and overall patient well being.

Poorly controlled acute pain can give rise to chronic pain. Chronic postsurgical pain (CPSP) is a complex clinical entity with profound implications for postoperative long term outcomes and quality of life. It persists beyond the normal healing period (3 months), and encompasses various dimensions of pain severity, distress, and interference with daily activities. (8)

To the best of our knowledge there is there is no literature evaluating the incidence of chronic pain at primary and donor site following head neck cancer surgery with free tissue transfer reconstruction.

Thus, we to study the incidence and severity of chronic postoperative pain at primary and donor site in patients undergoing free flap reconstruction for head and neck cancer. 

Purpose:

The purpose of this study is to find the amount of pain in patients undergoing head, neck and plastic surgery. Pain scores on discharge and post operative day (day after the surgery) 30,60,180 will be noted. The pain killers used preoperatively, intraoperatively and postoperatively period will also be noted. In case if the pain is unbearable, we will refer the patient to the chronic pain services to take care of their pain and make them comfortable. No additional intervention will be done for the purpose of the study. On the day of discharge, we will also administer questionnaires to see the effect of pain and pain management techniques on quality of life and to understand the nature of pain.

This audit or study will help us to understand effectiveness of our current management and help us further improve the quality of care delivered.  We will record the necessary information from patients file, charts and electronic medical record and contact through telecommunication, WhatsApp, messages, and if possible assess physically.

 
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