FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/03/040867 [Registered on: 07/03/2022] Trial Registered Prospectively
Last Modified On: 04/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   PERSISTENT PAIN FOLLOWING OPERTION ON CHEST  
Scientific Title of Study   PERSISTENT PAIN FOLLOWING THORACIC SURGERY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Chatterjee 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dr. E Borges Marg, Parel, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  02224177051   
Fax    
Email  aparnasanjay@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aparna Chatterjee 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dr. E Borges Marg, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  02224177051   
Fax    
Email  aparnasanjay@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shital Tupkar 
Designation  Postgraduate student 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical Care & Pain, 2nd floor, Main Buiding, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177051   
Fax    
Email  shitaltupkar@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre 
 
Primary Sponsor  
Name  Dr Aparna Sanjay Chatterjee 
Address  Tata Memorial Hospital, Dr E Borges Road, PArel, Mumbai 
Type of Sponsor  Other [Principal investigator] 
 
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 Aparna Chatterjee  Tata Memorial Centre  Department of Anaesthesia, Critical Care & Pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA 
02224177051

aparnasanjay@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - adults undergoing thoracic surgery with intercostal incisions, all lateral incisions including single port/Multiple port.
- can read and write in English/Hindi/Marathi
 
 
ExclusionCriteria 
Details  - <18 years of age
- History of prior thoracic surgery
- Preoperative neuropathic pain
- A median sternotomy incision
- Unwilling to fill out a questionnaire
- Refusal of consent
- Cognitively impaired
- Emergency surgery
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify incidence and severity and nature of persistent pain at 3 and 6 months following thoracic surgery with intercostal incisions.  180 days 
 
Secondary Outcome  
Outcome  TimePoints 
- Postoperative pain severity and association with persistent pain
- Postoperative Analgesia techniques and association with persistent pain
 
180 days 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   15/03/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publications yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

One of the most severe types of postoperative pain is following a thoracotomy. Presence of 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 pneumonia1. Analgesic techniques such as Intercostal, paravertebral, interpleural and thoracic epidurals with local anesthetic and opioids have been employed for pain relief.2 Thoracic epidural analgesia (TEA) is by far the best option of relieving pain following a thoracotomy, especially with low concentration of local anesthetic and a lipophilic opioid.3 Neuropathic pain following thoracotomy, known as post thoracotomy pain is common , sometimes severe enough to incapacitate and often becomes chronic.4,5Post-thoracotomy pain syndrome or PTPS (chronic post-thoracotomy pain or post-thoracotomy neuralgia) is defined by the International Association for the Study of Pain (IASP) as ‘pain that recurs or persists along a thoracotomy incision at least two months following the surgical procedure’. In general, it is burning and stabbing pain with dysesthesia and thus shares many features of neuropathic pain6. Over the years there has been a gradual shift towards minimally invasive or thoracoscopic or VATS (video assisted thoracoscopic surgery) approach. This approach has shown early and better recovery with early discharge from the hospital.7 Despite being less invasive, VATS procedures have not had a favourable impact on pain as was anticipated.8 They too present with similar pain and sometimes even after discharge, and have been reported to be of neuropathic nature.9,10 The incidence of Chronic Post surgical pain11,12 following VATS approach has been reported in the range of 20-47%.

Grosen et al13, reported sensory changes in the painful area in 62% patients with post thoracotomy pain syndrome.  Simultaneous occurrence of pain and sensory disturbances caused by nerve injury is one of the mechanisms believed to cause PTPS.14 However, it has been noticed that, sensory disturbances are not always associated with pain15.

At Tata Memorial Hospital, over the last 10 years there has been as steady shift towards minimally invasive VATS approach for thoracic surgeries. A thoracic epidural catheterization, which is an important aspect for providing analgesia for thoracotomy, is seldom employed in those undergoing VATS approach. The trend is to use IV opioids intraoperatively along with NSAIDS (if not contraindicated) & Paracetamol along with IV PCA (Patient controlled analgesia) postoperatively.

The purpose of the study is to determine the incidence, nature and severity of persistent pain if any at 3 and 6 months following thoracic surgery with intercostal incisions 

 

REFERENCES

1.      Perttunen K, Nilsson E, Heinonen J, Hirvisalo EL, Salo JA, Kalso E. Extradural, paravertebral and intercostal nerve blocks for post-thoracotomy pain. British journal of anaesthesia. 1995 Nov 1;75(5):541-7.

2.      Gottschalk A, Cohen SP, Yang S, Ochroch EA, Warltier DC. Preventing and treating pain after thoracic surgery. The Journal of the American Society of Anesthesiologists. 2006 Mar 1;104(3):594-600

3.      Slinger P, editor. Principles and practice of anesthesia for thoracic surgery. Springer Science & Business Media; 2011 Jul 12

4.      Karmakar MK, Ho AM. Postthoracotomy pain syndrome. Thorac Surg Clin. 2004 Aug;14(3):345-52. doi: 10.1016/S1547-4127(04)00022-2. PMID: 15382766 5.Butler S,Jonzon B, Branting-Ekenback C et al.Predictors of severe pain in a cohort of 5271 individuals with self reported neuropathic pain. Pain 2013;154:141-6.

6.      Koehler RP, Keenan RJ. Management of postthoracotomy pain: acute and chronic.

Thorac Surg Clin. 2006 Aug;16(3):287-97. doi: 10.1016/j.thorsurg.2006.05.006. PMID: 17004557

7.      Doki Y, Ichiki K, Tsuda M et al. Complete port-accessed lobectomy by the muscle sparing method.Ann Thoracic Surg;77:2230-1

8.      Landreneau RJ, Mack MJ, Hazelrigg SR, Naunheim K, Dowling RD, Ritter P, Magee MJ, Nunchuck S, Keenan RJ, Ferson PF. Prevalence of chronic pain after pulmonary resection by thoracotomy or video-assisted thoracic surgery. The Journal of thoracic and cardiovascular surgery. 1994 Apr 1;107(4):1079-86

9.      Homma T, Doki Y, Yamamoto Y, Ojima T, Shimada Y, Kitamura N, Yoshimura N. Risk factors of neuropathic pain after thoracic surgery. Journal of Thoracic Disease. 2018 May;10(5):2898

10.  Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A prospective study of chronic pain after thoracic surgery. Anesthesiology. 2017 May;126(5):938-51.

11.  Wang H, Li S, Liang N , Liu W, Liu H. Postoperative pain experiences in Chinese  adult patients after thoracotomy and VATS surgery.J Clin Nurs. 2017;20(17-18) : 2744-2754

12.  Weinrib AZ, Azam MA, Birnie KA, Burns LC, Clarke H, Katz J. The psychology of chronic post-surgical pain : new frontiers in risk factor identification, prevention and management. Br. J. Pain. 2017;11(4):169-177

13.  Grosen K, Laue PG, Pfeiffer-Jensen M, Hoejsgaard A, Pilegaard HK. Persistent postsurgical pain following anterior thoracotomy for lung cancer: a cross-sectional study of prevalence, characteristics and interference with functioning. Eur J Cardiothorac Surg.

2013;43(1):95–103

14.  Doan LV, Augustus J, Androphy R, Schechter D, Gharibo C. Mitigating the impact of acute and chronic post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1048-56. doi: 10.1053/j.jvca.2014.02.021. PMID: 25107721.

15.  Wildgaard K, Ravn J, Nikolajsen L, Jakobsen E, Jensen TS, Kehlet H. Consequences of persistent pain after lung cancer surgery: a nationwide questionnaire study. Acta Anaesthesiol Scand. 2011 Jan;55(1):60-8. doi: 10.1111/j.1399-6576.2010.02357.x. Epub 2010 Nov 15. PMID: 21077845.

 
Close