| 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
|
|
|
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
|
|
|
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. |