| 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
|
|
|
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
|
|
|
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. |