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CTRI Number  CTRI/2024/04/065069 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A future study involving observation aimed to assess pain occurring after surgery at the surgical sites in head and neck cancer patients who were undergoing cosmetic surgery. 
Scientific Title of Study   Postoperative donor site pain in head and neck cancer patients following reconstructive free tissue transfer surgery: A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Project no 4330 Version 1.0 dated 12 Sept 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vandana Agarwal 
Designation  Professor 
Affiliation  Tata Memorial Hospital,Mumbai 
Address  Department of Anesthesia, Critical Care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819762668  
Fax    
Email  vandanachaukar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana Agarwal 
Designation  Professor 
Affiliation  Tata Memorial Hospital,Mumbai 
Address  Department of Anesthesia, Critical Care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Parel Mumbai


MAHARASHTRA
400012
India 
Phone  9819762668  
Fax    
Email  vandanachaukar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Komal Nikhare 
Designation  Junior Resisdent 
Affiliation  Tata Memorial Hospital,Mumbai 
Address  Department of Anesthesia, Critical Care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8530609664  
Fax    
Email  komalnikhare1994@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel Mumbai-12 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Road, Parel Mumbai-12 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not Any  Not Any 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Komal Nikhare  Tata Memorial Hospital, Mumbai  Room No MB101 Male General Ward and MB102, Female General Ward, First Floor, Main Building, Tata Memorial Hospital, Dr E Borges Road, Parel,
Mumbai
MAHARASHTRA 
8530609664

komalnikhare1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Tata Memorial Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not Any  Not Any 
Comparator Agent  Not Any  Not Any 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adults age more than 18 years patients undergoing head and neck surgery with free flap reconstruction. 
 
ExclusionCriteria 
Details  3 Age less than 18 years
2 Patients requiring prolonged post-operative ventilator support more than 2 days
1 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 donor site pain in the postoperative period  up to day 5 after enrollment  
 
Secondary Outcome  
Outcome  TimePoints 
1 Nature of pain Somatic or neuropathic based on patients description  up to day 5 after enrollment  
2 Incidence of Neuropathic pain  up to day 5 after enrollment 
3 Duration of analgesics used in the postoperative period  up to day 5 after enrollment  
4 Need for Acute Pain Services referral  up to day 5 after enrollment  
 
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)   15/04/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 become a gold standard for reconstruction in head and neck cancers. Radial artery, Antero lateral thigh and Fibula osteo-cutaneous flap are three most popular free flaps for reconstruction following head and neck cancer resections. The goals of reconstructive surgery are to restore appearance and functions like speech, swallowing. The success rate of free flapis more than 95%in majority of centers.

 

However, there are certain disadvantages such as mild postoperative deficits and rarelypatients may experience significant donor-site morbidity. Minimizing flap donor site morbidity is equally important.Donor site complications are hematoma, infection, wound dehiscence, sensory loss, pain, gait disturbances, limb weakness, neuroma, seroma, etc. The overall incidence of acute pain in head and neck cancer surgery is high. Pathological cancer staging, surgicalcomplexity, tumor site are associated with increase in severity of pain. In addition treatment, these patients may often be on mild to moderate analgesics for acute pain.Hinther et al,reported high prevalence of chronic postoperative opioid use in patients undergoing head and neck cancer surgery with free flap reconstruction. They identified preoperative opioid use, prior tobacco use, tumor stage, and adjuvant treatment as risk factors for chronic postoperative opioid use.The etiology of postoperative chronic opioid use are complex and multifactorial.Postoperative period isvery crucial forachieving optimal analgesia with minimal side effects but also decreasing the risk of chronic opioid use.

 

To the best of our knowledge, there is no literature evaluating impact ofreconstructive surgery and donor site pain on overall incidence of pain in head and neck surgery

Donor site pain can be due to multitude factors such as nerve injury, muscle excision and injury, bone excision causing neuropathic, somatic pain. It may be anadditional source pain, morbidity and quality of life of these patients. However, there is sparse literature evaluating the severity, duration of acute donor site pain associatedmorbidity,use and duration of postoperative opioids and its impact on quality of life.

 

Methods and materials:

After IEC and CTRI approval, patients will be screened one day before surgery for enrollment in the study. Informed consent form will be administered in the ward following hospital admission. All patients undergoing head and neck cancer surgery in TMH will be recruited. Perioperative data of patients undergoing elective head and neck cancer surgery will be recorded in the case record form. Patients will be followed until postoperative day (POD)5. Pain score (NRS) at donor site (i.e. flap and skin graft), and surgical site will be recorded once a day. The lowest, and worst pain score both at rest and on movement will be recorded. NRS will be recorded on postoperative day 1, 3, and 5.  Brief Pain Inventory (BPI) and Pain DETECT questionnaire  will be administered at discharge.

 

Statistical analysis:

Descriptive data will be expressed as mean or median depending on the distribution of data and to report the results of the questionnaire items. Categorical data will be analyzed using the chi-square test or Fisher Exact test (for binary data). Logistic regression   will   be used for multivariate analysis to find predictive factors associated with NRS score >5.P-value < 0.05 will be considered statistically significant.We will analyse the data at the end of May 2024, for the purpose of thesis.

Ethical considerations:

Patients will be identified by a unique no. and access to study documents will be available only to the investigators and the Institutional Ethics Committee. The trial will be conducted in compliance with the “Ethical Guidelines for Biomedical Research on Human Participants” by the ICMRand ICH-GCP and according to approved study protocol and applicable regulations. 
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