| CTRI Number |
CTRI/2026/03/105342 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Oncosurgical patient post op pain management satisfaction |
|
Scientific Title of Study
|
Post Operative Pain Management in Oncosurgerical Patients:An Observational Analysis of Outcome And Satisfaction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nirali Paanchal |
| Designation |
Professional of department of Anaesthesiology |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical College,Shree krishna Hospital,Karamsad,Anand,Gujarat.
Anand
GUJARAT
388325
India |
| Phone |
9825031808 |
| Fax |
|
| Email |
dr.niralipanchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirali Paanchal |
| Designation |
Professional of department of Anaesthesiology |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical College,Shree krishna Hospital,Karamsad,Anand,Gujarat.
Anand
GUJARAT
388325
India |
| Phone |
9825031808 |
| Fax |
|
| Email |
dr.niralipanchal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Elisha Patel |
| Designation |
1st year resident |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical College,Shree krishna Hospital,Karamsad,Anand,Gujarat.
Anand
GUJARAT
388325
India |
| Phone |
8849325142 |
| Fax |
|
| Email |
elishapatel1508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology,Pramukh Swami Medical College,Shree krishna Hospital,Karamsad,Anand,Gujarat. |
|
|
Primary Sponsor
|
| Name |
Shree krishna hospital |
| Address |
Shree Krishna Hospital, Karamsad, Anand, Gujarat, India ,388325 |
| Type of Sponsor |
Private medical college |
|
|
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 Nirali Panchal |
shree Krishna Hospital |
Department of Anesth esiology,Surgical operation theater complex Anand, GUJARAT
Anand
GUJARAT |
9825031808
dr.niralipanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University,Karamsad,Anand,Gujarat- 388325 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: R458||Other symptoms and signs involvingemotional state, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients posted for oncosurgeries |
|
| ExclusionCriteria |
| Details |
Patients remain intubated
Patients undergoing emergency surgery
Patients undergoing neurosurgical oncology procedures
Patients with life-threatening illness
Patients with impaired cognition
Patients with a history of substance abuse Patients currently on antiepileptic medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of postoperative pain management in oncosurgery patients using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R), focusing on patient-reported pain intensity and relief,evaluate the impact of pain on . physical function, emotional well-being, and sleep quality |
24 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the incidence & nature of pain-related side effects
To explore associations between pain outcomes & demographic or clinical factors
To assess patient satisfaction with postoperative pain management |
24 hours postoperative |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
15/03/2026 |
| 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
|
Postoperative pain (POP) remains a significant global healthcare challenge. Despite advancements in surgical techniques and pharmacological options, many patients continue to experience moderate to severe pain after surgery. This has been linked to inconsistent pain assessment, limited availability or underuse of opioids, lack of provider training, and absence of structured pain protocols, particularly in resource-limited settings [1,2,3]. These deficiencies not only impair patient comfort but also contribute to complications, prolonged hospital stays, and reduced satisfaction with care [2,4]. International studies have shown that effective POP management improves substantially with the use of validated pain assessment tools and structured feedback systems. Institutions that have implemented such approaches report better pain relief outcomes and fewer side effects [3,4]. For instance, hospitals in Southeast Asia and North Africa have documented low opioid usage and inadequate analgesic practices due to regulatory constraints and lack of standardized protocols [1,3]. In India, similar issues persist. Although analgesics are generally available, pain is often under-assessed due to the absence of consistent documentation and language-appropriate tools. Studies in tertiary care centers have found variable practices and low patient satisfaction linked to this inconsistency [6,7]. To address the language barrier, the APS-POQ-R tool has been recently translated and validated in Hindi and Marathi, providing a reliable, culturally relevant instrument for Indian patients [8]. However, its routine use in clinical settings, especially for cancer surgery patients, is still limited. Acute Pain Services (APS) are structured, multidisciplinary teams aimed at providing consistent, effective, and patient-centered pain management. These services include regular assessment, personalized analgesic regimens, patient education, and outcome monitoring. While APS has demonstrated success in improving postoperative outcomes globally, its adoption in India remains sporadic and often lacks standardization [10]. The need for structured pain assessment is especially important in oncosurgery patients, who typically undergo more extensive procedures, often with pre-existing cancer-related pain. Inadequate postoperative pain control in this group can lead to poor functional recovery, immune suppression, psychological distress, and delays in starting chemotherapy or radiotherapy. Additionally, patients may underreport pain or accept it as inevitable, masking the actual burden [5]. The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) is a validated tool that captures various aspects of the pain experience, including intensity, functional interference, side effects, and satisfaction with treatment [9]. Applying this tool specifically in oncosurgical patients can help assess current practices, identify shortcomings, and support the development of evidence-based Acute Pain Services tailored to oncology care in India. |