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CTRI Number  CTRI/2025/07/091523 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study of the type, severity and duration of pain after surgery for removal of tumours of the chest wall in adult patients  
Scientific Title of Study   Ambispective observational study of Perioperative acute pain management and incidence of chronic chest pain after chest wall excision involving excision of rib and intercostal nerve in adult cancer patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhavi Shetmahajan 
Designation  Prof and head, Clinical Anaesthesia 
Affiliation  Tata Memorial Centre  
Address  Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, E Borges, Parel, Mumbai, India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, E Borges, Parel, Mumbai, India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India 
Phone  9819372075  
Fax    
Email  mshetmahajan@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Madhavi Shetmahajan 
Designation  Prof and head, Clinical Anaesthesia 
Affiliation  Tata Memorial Centre  
Address  Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, E Borges, Parel, Mumbai, India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, E Borges, Parel, Mumbai, India Mumbai MAHARASHTRA 400012 India

MAHARASHTRA
400012
India 
Phone  9819372075  
Fax    
Email  mshetmahajan@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Purva Kale 
Designation  Junior Registrar 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, E Borges, Parel, Mumbai, India Mumbai MAHARASHTRA 400012 India
Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, E Borges, Parel, Mumbai, India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India 
Phone  9604359022  
Fax    
Email  purvakale11@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  E Borges Marg, Parel, Mumbai 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 
Purva Kale  Tata Memorial Hospital   Main Operation Theatre complex, Second floor, Dept of Anaesthesiology, Critical care and pain, Tata memorial Hospital ,E borges marg, Parel, Mumbai 400012 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9604359022

purvakale11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Institutional Ethics Committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients aged 18 years to 99 years undergoing surgical resectionofchest wall involving excision of ribs and intercostal nerves. 
 
ExclusionCriteria 
Details  1. Any patient having additionalincisions.
2.Any chest wall tumor resection in which ribs/ intercostals are not resected.
3. Unwilling to fill out a questionnaire.
4. Refusal of consent
5. Unable to understand Hindi, Marathi or English
6. Patients with pre-existing diagnosed cognitive dysfunction
7. Pregnant patient
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Worst pain score in the first 24 hours after surgery  Worst pain score in the first 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain scores at rest and on deep breathing in the first 24 hours after surgery
2. Proportion of patients in moderate and severe pain on D0-D3
3. Dermatomal distribution of sensory deficit at hospital discharge, 3 months and 6 months
4. Incidence of chronic pain at 3 months and 6 monthsafter surgery
5. Methods of chronic pain management
 
Pain scores will be recorded at 0-2 hours, 5-7 hours, 19-22 hours after surgery, at 9-10 AM on postoperative day 2-5.

Chronic pain endpoints will be assessed at hospital discharge and at 3 months and 6 months post surgery. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   04/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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

 Postoperative analgesia for chest wall excision surgeries is important as it directly affects the respiratory mechanics of the patient. Inadequate analgesia usually results in inability to breathe deeply and cough forcefully, both of which hamper postoperative pulmonary rehabilitation with subsequent retention of secretions, atelectasis and pneumonia.

 In chest wall surgeries, ribs and intercostal nerves are resected. Logically, the area distal to the excised nerve should be insensitive and therefore painless. However cross innervation from intact adjoining intercostal nerves can contribute to pain sensation. The underlying pathophysiology of pain after excision of chest wall along with the rib and intercostal nerve can be both somatic and neuropathic. The severity of pain would also depend upon the extent of surgery and methods of postoperative analgesia.

While there is abundant literature on post thoracotomy acute and chronic pain, studies on pain after chest wall excisions are lacking. Pain after rib resection is likely to be different from that after thoracotomy incisions. In thoracotomy procedures, during rib spreading, multiple intercostal nerves are injured. Typically, the nerves immediately above and below the incision may be injured completely or partially. The type of injury may be different as the nerve is not resected completely. Therefore, the severity and character of pain after rib and intercostal nerve excision may be different from that of thoracotomy incisions limiting the extrapolation of information regarding one to the other.

We therefore plan to conduct this observational study to understand the character of acute and chronic pain in these cases and examine its association if any with the sensory deficits consequent to intercostal nerve excision. As chronic pain data will be difficult to obtain retrospectively, we will study chronic pain prospectively and acute pain both prospectively and retrospectively. 

AIM AND OBJECTIVES

Aim: 1. To understand incidence and character of postoperative acute and chronic pain after chest wall excision involving rib and intercostal nerve excision

2. To understand management of postoperative acute and chronic pain in these patients.

3. To identify areas of sensory deficit after these surgeries and its association with the incidence and site of acute and chronic pain.

Primary objective: To evaluatea cute pain incidence and severity after rib and intercostal nerve excision and the pain management technique used

METHODOLOGY:

Single centre ambispective study conducted in a tertiary care cancer hospital.

Study duration:Retrospective: 5 years: 1st January 2020 to 31st December 2024.

Prospective:  2 years

We expect to recruit around 80-100 patients in the retrospective study and around 50 patients prospectively

The retrospective data will be collected   from the patient’s electronic medical record (EMR), acute pain service (APS) database, physical forms and case file wherever available. The worst pain scores and pain scores at rest and on deep breathing will be recorded for 5 postoperative days.  Retrospectively patients will be recruited from thoracic database, hospital OT register and OT logbook.

Prospective study:

The study will commence after IEC approval and CTRI registration. Patients undergoing chest wall excision surgery will be screened for inclusion and exclusion criteria. Eligible patients will be recruited after obtaining an informed consent.

The patients’ demographic data and preoperative analgesic usage will be recorded. Details of intraoperative and postoperative analgesia including methods of pain relief and numerical pain scores at rest and deep breathing will be recorded. i

At discharge, 3 and 6 months after surgery, the patient will be administered the painDETECTquestionnaire to diagnose neuropathic pain. Brief pain inventory (BPI) will also be administered to assess the severity of pain and impact of pain on daily functions at discharge and around 3 and 6 months postoperatively. Analgesics consumed by the patient will be recorded. Sensations at the surgical site will be recorded at discharge, 3 and 6 months after surgery. The patients will be examined at around 3 and 6 months when they visit the hospital as part of their standard postoperative follow up. If they do not visit the hospital at around 3 and 6 months, a member of the study team will contact the patient telephonically or by email to collect the relevant data. 

Chronic Pain Assessment

PainDETECTquestionnaire :

The PainDETECT Questionnaire (PDQ) will be used distinguish between neuropathic and nociceptive pain (NP). This PDQ will be explained and given to the patient at discharge, 3 and 6 months to diagnose neuropathic pain. The patients will be examined at discharge and at 3 and 6 months when they visit the hospital as part of their standard postoperative follow up. If they do not visit the hospital at 3 and 6 months, a member of the study team will contact the patient to collect the relevant data by telephone or email.The PDQ will be administered to the patients in the language they understand.

 Brief pain inventory ( BPI)

The BPI is an instrument to assess the severity of pain and impact of pain on daily functions in patients with pain from chronic diseases. The short form comprises of nine questions related to the severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.

Statistics

Data will be described as frequencies and percentages. Categorical data will be compared using the chisquare/Fisher’s test and numerical data will be compared using the unpaired t-test or the Mann Whitney Utest. p values less than 0.05 will be considered significant for all comparisons. Data will be entered into a statistical software (SPSS 22.0) for analysis.

 


 
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