| CTRI Number |
CTRI/2026/04/109290 [Registered on: 24/04/2026] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Painkillers Affect Bone Healing After Tibia Surgery Comparing Diclofenac and Tramadol |
|
Scientific Title of Study
|
Effect of Diclofenac Versus Tramadol on fracture healing following intramedullary Nailing of tibia:A Randomized control trial study |
| 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 Niranjan Atpadkar |
| Designation |
PG Resident Orthopaedics |
| Affiliation |
Chhattisgarh Institute of Medical Sciences,Bilaspur |
| Address |
Chhattisgarh Institute of Medical Sciences,Gond Para, Sadar Bazar, Bilaspur,Chhattisgarh,India
Bilaspur
CHHATTISGARH
495001
India |
| Phone |
9004718832 |
| Fax |
|
| Email |
niranjanatpadkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravikant Das |
| Designation |
Professor and HOD, Department of Orthopaedics |
| Affiliation |
Pt.JNM Medical College,Raipur |
| Address |
E-9 Doctor’s housing Campus,Pt. J.N.M.Medical College,Raipur,Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827184212 |
| Fax |
|
| Email |
drravikantdas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kr Ghilley |
| Designation |
Assistant Professor,Department of Orthopaedics |
| Affiliation |
Chhattisgarh Institute of Medical Sciences,Bilaspur |
| Address |
Flat No 204,A block,Real Heavens Apartment,Shanti nagar ,Mangla Chowk,Bilaspur,Chhattisgarh
Bilaspur
CHHATTISGARH
495001
India |
| Phone |
9038919277 |
| Fax |
|
| Email |
Sanjay.lifesgud@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chhattisgarh Institute of Medical Sciences,Bilaspur |
| Address |
Chhattisgarh Institute of Medical Sciences, Gond Para, Sadar Bazar, Bilaspur, Chhattisgarh - 495001, India |
| Type of Sponsor |
Government 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 Niranjan Atpadkar |
Chhattisgarh institute of Medical Sciences |
Department of Orthopaedics,Ground Floor,CIMS,Bilaspur,Chhattisgarh
Bilaspur
CHHATTISGARH |
9004718832
niranjanatpadkar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,CIMS,BILASPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S822||Fracture of shaft of tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet Diclofenac |
Dose-50MG, Frequency-Two Times A Day, Route of Administration-Per Oral, Duration Of Therapy-7 Days Post Operatively |
| Intervention |
Tablet Tramadol |
Dose-50MG, Frequency-Two Times A Day, Route of Administration-Per Oral, Duration Of Therapy-7 Days Post Operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Fracture type Closed fractures As well as Gustillo Anderson Classification type 1 Open Fracture.
Patients undergoing intramedullary nailing as the primary treatment.
Patients who will provide informed written consent.
Patients suitable for receiving either Diclofenac or tramadol for postoperative pain management. |
|
| ExclusionCriteria |
| Details |
Patient with pathological fractures as well as gustillo Anderson classification type 2,3 open fractures.
Patient with comorbid conditions such as hepatic or gastrointestinal disorders that will contraindicated diclofenac use.
Known hypersensitivity or intolerance to either tramadol or Diclofenac.
History of chronic use of Diclofenac, opioids within the last 3 months.
Patients unlikely to adhere to follow-up protocol or have significant psychiatric illness.
Female patients who are pregnant or breastfeeding. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fracture healing assessed both clinically (absence of tenderness or pain on weight bearing) and radiologically (bridging callus seen in 4 cortices on AP and lateral views). |
4 Weekly radiological assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Time taken to achieve union incidence of delayed union
2 Time taken to achieve union incidence of nonunion or no progression
3 Pain score by Visual Analog Scale |
24 Weeks
36 Weeks
1,3 Days 1,2,4,6,12,24 Weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/05/2026 |
| 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 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
|
A Randmoized control Trial study In which Patients with tibial fractures are screened based on inclusion and exclusion criteria followed by informed consent will obtained and participants will be randomized into two groups Group A Diclofenac and Group B Tramadol.
All patients underwent tibia nailing surgery followed by postoperative analgesia as per group allocation Clinical VAS scores and radiological X rays at 4 6 12 and 24 weeks assessments are conducted to monitor pain relief and fracture healing.
The two groups are compared for pain control efficacy as well as time to radiological union and incidence of complications to determine the impact of Diclofenac versus Tramadol on postoperative fracture healing. |