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CTRI Number  CTRI/2024/06/068668 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Quality improvement project]  
Study Design  Single Arm Study 
Public Title of Study   Improving Acute Pain services in orthopedic trauma patients in a trauma center of India 
Scientific Title of Study   A multidisciplinary team approach for improving the Acute Pain Services in Orthopaedic Trauma in a level I trauma centre of India: A Quality Improvement Project 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Riniki Sarma 
Designation  Assistant Professor 
Affiliation  JPNATC, AIIMS 
Address  Room no-122, Dept of Anesthesia (JPNATC), AIIMS

South
DELHI
110029
India 
Phone  8447456976  
Fax    
Email  rinikirs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Riniki Sarma 
Designation  Assistant Professor 
Affiliation  JPNATC, AIIMS 
Address  Room no-122, Dept of Anesthesia (JPNATC), AIIMS


DELHI
110029
India 
Phone  8447456976  
Fax    
Email  rinikirs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Riniki Sarma 
Designation  Assistant Professor 
Affiliation  JPNATC, AIIMS 
Address  Room no-122, Dept of Anesthesia (JPNATC), AIIMS


DELHI
110029
India 
Phone  8447456976  
Fax    
Email  rinikirs@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical sciences, New Delhi 
 
Primary Sponsor  
Name  JPN Apex Trauma Centre AIIMS 
Address  Ring Road, New Delhi-110029 
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 Riniki Sarma  JPN Apex Trauma Centre,All India Institute of Medical Sciences, New Delhi  Room no-122, Dept of Anesthesia (JPNATC), All India Institute of Medical Sciences
South
DELHI 
8447456976

rinikirs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T798||Other early complications of trauma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Postoperative pain in patients after quality improvement measures  NRS scores in patients on post-operative day 1,2,3,4 
Comparator Agent  Postoperative pain in patients before quality improvement measures  NRS scores in patients on post-operative day 1, 2,3,4  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients admitted in the orthopaedic wards of JPN Apex trauma centre will be included in the study. 
 
ExclusionCriteria 
Details  Patients who were admitted in the ICU postoperatively or transferred to the intensive care unit during their stay in the wards would be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in NRS score by 50% at the time of discharge after implementation of QIP  At seventh day on day of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
NRS at immediate postoperative period  Immediate postoperative period 
patient satisfaction score  at discharge 
Time from analgesic request to analgesic administration  post-operative period 
 
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)   25/06/2024 
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 Yet Recruiting 
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  

Acute postoperative pain management in orthopaedic trauma patients is paramount for ensuring optimal recovery and patient comfort. Employing a multimodal approach, is essential to address the multifaceted nature of postoperative pain. Opioid analgesics remain the cornerstone in pain management; however, their use should be judicious due to the associated risks of tolerance and dependence, and untoward  systemic effects like respiratory depression, nausea and vomiting and urinary retention. Non-opioid analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and neuropathic pain medications can complement opioids while reducing their overall dosage. Regional anesthesia techniques, such as epidural analgesia or peripheral nerve blocks, offer effective pain relief while minimizing systemic opioid exposure. Individualized treatment plans, tailored to patients’ specific needs and risk profiles, are essential for optimizing postoperative pain management outcomes in orthopaedic trauma settings.

Despite substantial advancement in availability of drugs and regional techniques, pain relief continues to be suboptimal across all types of postoperative patients. As a solution, evidence based acute pain services (APS) was introduced to manage postoperative pain. It is a dedicated round the clock team of health care personnel that assesses, monitors and treats pain and the side effects of analgesic techniques/medications (3). APS has been started and managed by the Department of Anesthesia of our trauma centre since 2012. However, it is not clear as to what extent the patients felt benefitted. The APS was a well-structured system with routine training and education of staff on pain management, extensive and meticulous pain rounds and prompt referrals to APS team in case of any perioperative pain. During the Covid-19 pandemic, there was a sudden disruption in the efficient management of APS. Post Covid-19, when the Trauma centre started functioning to its full capacity, it was noted that there was a significant drop in the performance of APS. Suboptimal competence indicates the need of re-training health personnel and incorporating strategies to improve the quality of care. Hence, we decided to conduct this Quality Improvement Project involving nursing staff, orthopaedicians, anesthesiologists  team and operation theatre (OT) T technologists  for capacity building of the APS and to evaluate its effectiveness and sustainability in a high-volume level I trauma centre of India.

 
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