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CTRI Number  CTRI/2026/02/102866 [Registered on: 03/02/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study Comparing Different Methods of Pain Relief After Uterus Removal Surgery 
Scientific Title of Study   Comparison of Diclofenac Suppository, Patch and Intramuscular Injection for Postoperative Analgesia in patients undergoing Abdominal Hysterectomy under Spinal Anaesthesia 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranjith Kumar J 
Designation  Pg Scholar 
Affiliation  SRM Institute of Science and Technology 
Address  Room No:D4 23,4th floor, D block Extension, Department of Anesthesia SRM medical college, SRM Nagar Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu 603203

Chennai
TAMIL NADU
603203
India 
Phone  9360675986  
Fax    
Email  rk9984@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Ranjith Kumar J 
Designation  Pg Scholar 
Affiliation  SRM Institute of Science and Technology 
Address  Room No:D4 23,4th floor, D block Extension, Department of Anesthesia SRM medical college, SRM Nagar Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu 603203


TAMIL NADU
603203
India 
Phone  9360675986  
Fax    
Email  rk9984@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Ranjith Kumar J 
Designation  Pg Scholar 
Affiliation  SRM Institute of Science and Technology 
Address  Room No:D4 23,4th floor, D block Extension, Department of Anesthesia SRM medical college, SRM Nagar Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu 603203


TAMIL NADU
603203
India 
Phone  9360675986  
Fax    
Email  rk9984@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology 
 
Primary Sponsor  
Name  SRM Institute of Science And Technology 
Address  SRM Medical college Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu, 603203, 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 Dheepak KumaranAS  SRM Medical College Hospital  Room No:D4 23,4th floor, D block Extension, Department of Anesthesia SRM medical college, SRM Nagar Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu 603203 India
Chennai
TAMIL NADU 		 9360675986

dheepaka@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre Institutional Ethics Committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diclofenac sodium 100 mg rectal suppository for postoperative analgesia  Arm A – Diclofenac Suppository Intervention: Diclofenac sodium rectal suppository Dose: 100 mg Route of administration: Rectal Timing: First dose administered immediately at the end of surgery. Frequency: Every 12 hours Duration: First 24 hours postoperatively. Indication: Postoperative analgesia following abdominal hysterectomy under spinal anaesthesia. 
Intervention  Diclofenac sodium 100 mg transdermal patch for postoperative analgesia  Arm B – Diclofenac Transdermal Patch Intervention: Diclofenac sodium transdermal patch Dose: 100 mg Route of administration: Transdermal Timing: Patch applied 1 hour before the end of surgery Frequency: Single application (effective for 24 hours) Duration: First 24 hours postoperatively Site of application: Lateral aspect of the dominant upper arm (deltoid region) Indication: Postoperative analgesia following abdominal hysterectomy under spinal anaesthesia 
Comparator Agent  Diclofenac sodium 75 mg intramuscular injection for postoperative analgesia  Arm C – Diclofenac Intramuscular Injection (Comparator) Intervention: Diclofenac sodium intramuscular injection Dose: 75 mg Route of administration: Intramuscular Timing: First dose administered immediately at the end of surgery Frequency: Every 12 hours Duration: First 24 hours postoperatively Indication: Postoperative analgesia following abdominal hysterectomy under spinal anaesthesia 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1.Patients age group between 35to 70 years
2.Patients with ASA I, II & III
3.Patients having BMI of less than or equal to 40 kg/m²
4.Patients who scheduled for elective abdominal hysterectomy under spinal anesthesia.
5.Expected to stay in the hospital for at least 24 h after surgery 
 
ExclusionCriteria 
Details  1.Patients with impaired cognitive function or psychiatric disorders
2.Patients who decline participation or withdraw consent
3.Patients with history of chronic pain
4.Patients with history of allergy to local anaesthetics or NSAIDs.
5.Patients with coagulopathy and cardiovascular disease.
6.Patients with history of kidney disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The findings from this research will provide valuable evidence to guide clinical decision making in postoperative pain management, potentially improving patient outcomes, satisfaction and quality of care.  1.Patients will be assessed for their baseline pain level using the Visual Analog Scale (VAS) during preanesthetic visit.
2.Intervention administration: At end of surgery / 1 hour before end of surgery (patch)
3.Postoperative pain assessment: Every 2 hours for 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Rescue analgesic requirement, time to first rescue analgesia, patient satisfaction score, and incidence of adverse effects assessed during the first 24 postoperative hours.  Every 2 hours for first 24-hour postoperative period 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 4 
Date of First Enrollment (India)   16/02/2026 
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="0"
Months="6"
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   This prospective, randomized, open-label study compares the postoperative analgesic efficacy of diclofenac administered as a rectal suppository, transdermal patch, and intramuscular injection in patients undergoing elective abdominal hysterectomy under spinal anaesthesia. Ninety ASA I–III patients are randomly allocated into three groups. Postoperative pain is assessed using the Visual Analog Scale every two hours for 24 hours. Rescue analgesic requirement, patient satisfaction, and adverse effects are evaluated to identify an effective and patient-friendly alternative to intramuscular diclofenac. 
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