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CTRI Number  CTRI/2024/08/071824 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
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 patient satisfaction with the pain relief services provided after surgeries 
Scientific Title of Study   Patient satisfaction with postoperative pain management at a Tertiary Cancer Centre: A Prospective Audit 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4471_version 1.0 dated 15.04.24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Chatterjee 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9322243936  
Fax    
Email  aparnasanjay@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aparna Chatterjee 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital


MAHARASHTRA
400012
India 
Phone  9322243936  
Fax    
Email  aparnasanjay@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tamanna Raghuwanshi 
Designation  Junior Resident 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9028534008  
Fax    
Email  trraghuvanshi474@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012, Maharashtra, India 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012, Maharashtra, India 
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 Aparna Chatterjee  Tata Memorial Hospital  Dept of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
9322243936

aparnasanjay@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  99.00 Year(s)
Gender  Both 
Details  1. Adult patients more than 18years old
2. Those undergoing major surgery
3. Those not likely to require overnight ventilation beyond the night of surgery
 
 
ExclusionCriteria 
Details  1. Patients less than 18 years of age
2. Those requiring ventilation beyond the night of surgery
3. Postoperative patients not under APS care
4. Refusal of consent
5. Cognitively impaired
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients satisfied with acute pain services provided to them postoperatively  on postoperative day 3 or post regional/epidural catheter removal 
 
Secondary Outcome  
Outcome  TimePoints 
1. Predictors of satisfaction as obtained from the satisfaction questionnaire  On postoperative day 3 or post catheter removal 
2. Pain relief in first 48 hours based on Pain score (average & worst in first 48 hours)  AT post operative 48 hours 
3. Side effects of pain management techniques/drugs  on postoperative day 3 or post catheter removal 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   12/08/2024 
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:

Pain is an inevitable outcome of surgery. Patient’s who undergo surgery will invariably have pain because of the intra operative tissue handling, which leads to tissue damage results in pain. Pain relief has been accepted by the World Health Organization as a basic human right and is now considered as the 5th Vital sign (1)Globally, postoperative pain is a major concern and is well known that untreated or suboptimal treated postoperative pain , could lead to a variety of negative consequences such as, myocardial ischemia, pulmonary complications, delayed mobilization with increased incidence of thromboembolic episodes , impair rehabilitation, prolong hospital stay decrease quality of life and increase the risk for the development of persistent postsurgical pain and thereby chronic pain (2) However, Pain relief and the procedures done thereof, are also associated with certain side effects such as sedation, respiratory depression, postdural puncture headache (PDPH), nausea, vomiting etc.  Traditionally, pain scores and  side effects were the major outcome measures for service improvement, however in recent times patient satisfaction is considered an important tool to measure outcomes.

Patient satisfaction is the measure of the extent to which the patient is content with the health care they receive from the provider. (3) Pain management may be affected by multiple factors such as the gender ,age, preoperative expectations, information given prior to surgery, ASA status, pain medications, type of surgery & anesthesia, communication of staff with patient, prior experience of pain and current pain relief which may affect patient satisfaction.

In 1991, the American Pain Society (APS)  published its first American Pain Society-Patient Outcome Questionnaire (APS-POQ) as part of quality assurance (QA) standards for the treatment of acute and cancer pain to assist health care organizations to explore patient experiences and outcomes (4). The revised version American Pain Society-Patient Outcome Questionnaire revised (APS-POQ-R) measures 6 aspects of quality, including (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment. (5) ability to participate in pain treatment decisions; and (6) use of non-pharmacological strategies. (5). The APS-POQ-R has since been found to be easy to administer and useful for quality evaluation in postoperative pain management. (6)

The revised version of the questionnaire APS-POQ-R has been translated & validated in Indian languages, chiefly Hindi & Marathi (7)

At our hospital approximately 9652 surgeries are performed annually. Majority of the patients, especially those undergoing thoracic, GI, Gynecology Urology and limb surgery have their postoperative pain managed by the Acute Pain Service (APS). In the last 6 months a total of 1797 patients were managed by the APS team. The APS team of doctors and a pain nurse visits the patients for the first 3 -4 postoperative days and sometimes longer as per need with the chief aim of ensuring good pain relief with no adverse effects.  Pain scores, catheter site check (epidural or otherwise) and any related side effects are documented and managed by the team. The pain scoring is based on a ten point numerical rating scale. The pain considered mild if scores are 3 or less, moderate when scores are 4 but less than 7 and severe when scores are greater than 7 on a Numerical rating scale which is a ten point scale from 0-10. Pain is assessed regularly after shifting  to the PACU, and at regular intervals in the postoperative period .

Despite improved knowledge, and advances with better options and modalities for postoperative pain management, suboptimal satisfaction with postoperative pain management is quite common. (8)

We therefore aimed to assess the level of satisfaction among our patients with the care provided by the Acute Pain Service.

AIM

Primary:

To assess patient satisfaction with the postoperative pain management by the APS using the APS-POQ-R that is percentage of patients satisfied with acute pain services.

Secondary: to identify

1.     Predictors of satisfaction as obtained from the satisfaction questionnaire

2.     Pain relief in first 48 hours based on Pain score (average & worst in first 48 hours)

3.     Side effects of pain management techniques/drugs

 

METHODOLOGY

Prospective observational study will be conducted over a period of 6 months after Institutional Ethics Committee approval and CTRI registration. Eligible patients will be enrolled after obtaining their consent.

The data will be retrieved from EMR and APS data and revised APQ form which will be administered by Pain sister under APS team on postoperative day 3 or post catheter removal. The information regarding age, sex, body mass index, ASA grading, name of surgery and other modalities used with general anesthesia to reduce postoperative pain will be collected. The postoperative pain on the day of surgery and POD 1 and POD2 will be recorded. The revised APQ form will be filled by patients with help of pain nurse in the language best suited to them that is Hindi, English, Marathi.


CONSENT

Written informed consent will be obtained from each study participant after a clear explanation of what they would have to do and take part in the study. Anyone not willing to participate in the study will be informed that they have the full right not to participate or stop at any time and those who are not voluntary will be excluded. Confidentiality will be guaranteed by keeping the secrecy of personal identification, keeping the completed questionnaires and checklist results in a well-secured area.

 

SAMPLE SIZE

Based on the departmental data, we estimate to screen more than 2000 patients in 6 months and therefore approximately 2000 patients can be recruited in 6 months (whichever is earlier).

 

STATISTICS

Categorical data will be reported as counts (percentage) and continuous variables will be reported as Mean (sd) or Median (IQR) depending on the distribution of data.

The Primary Objective Patient satisfaction is an item measured in the APS-POQ-R will be presented as mean(sd) or median(IQR) based on the distribution of data. Linear and logistic regressions will be used to identify the potential risk factors and subscale scores from the APS-POQ-R (except “patient satisfaction”), and surgical and demographic factors that will be predictors of satisfaction.  Risk factors significantly associated with patient satisfaction in univariate analysis were included in multiple linear regression, including gender, diagnosis (cancer), and chronic pain history, as well as all other items from the APS-POQ-R (except “patient satisfaction”). Average & worst in first 48 hours Pain score will be presented as mean(sd) or median(IQR) based on the distribution of data. Side effects of pain management techniques/drugs will be presented as counts and percentages. Normality assumptions will be assessed using the Kolmogorov-Smirnov test. P value set at 5% level of significance. All data analysis will be carried out using SPSS version 25.

 
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