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CTRI Number  CTRI/2025/08/093546 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of Tapentadol nasal spray vs multimodal systemic analgesia for pain relief in patient with multiple rib fracture 
Scientific Title of Study   Comparison of efficacy of Tapentadol nasal spray vs multimodal systemic analgesia for pain control in patient with multiple rib fracture 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjay Marwah  
Designation  Senior proffesor & Unit Head 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences  
Address  Department of surgery,Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences, Rohtak, Haryana, 124001, india
Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences, Rohtak, Haryana, 124001, india
Rohtak
HARYANA
124001
India 
Phone  7988589889  
Fax    
Email  drsanjay.marwah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepak 
Designation  Resident 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences  
Address  Department of surgery,Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences, Rohtak, Haryana, 124001, india
Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences, Rohtak, Haryana, 124001, india
Rohtak
HARYANA
124001
India 
Phone  8571011867  
Fax    
Email  deepakdpk185@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepak 
Designation  Resident 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences  
Address  Department of surgery,Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences, Rohtak, Haryana, 124001, india
Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences, Rohtak, Haryana, 124001, india

HARYANA
124001
India 
Phone  8571011867  
Fax    
Email  deepakdpk185@gmail.com  
 
Source of Monetary or Material Support  
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana Pincode- 124001 India 
 
Primary Sponsor  
Name  Sanjay Marwah 
Address  Senior Professor and unit head, Department of Surgery, PGIMS rohtak, Haryana Pincode- 124001 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Deepak  Pt. B.D. Sharma PGIMS   Department of General Surgery, PGIMS Rohtak,Haryana Pincode 124001 India
Rohtak
HARYANA 
8571011867

deepakdpk185@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethicss Committee, Pt B.D. Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S225||Flail chest, (2) ICD-10 Condition: S224||Multiple fractures of ribs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intravenous tramadol, intravenous paracetamol, intravenous diclofenac   intravenous tramadol, intravenous paracetamol, intravenous diclofenac these are being used for pain control. duration of intervention is hospital stay and till 7 days post discharge and patient discharge on oral tablet of all 3 drugs 
Comparator Agent  Tapentadol nasal spray  Tapentadol nasal spray is being used for pain control. duration of comparison during hospital stay & till 7 days post discharge 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with chest injury with two or more rib fracture
Patients between 18-65 years of age
 
 
ExclusionCriteria 
Details  Chest injury without rib fracture or with a single rib fracture
Glasgow coma scale less than 15
Patients on ventilator support
Patients requiring epidural analgesia
Patients leaving against medical advice or in hospital mortality
Known allergy to study drug
Patients with severe renal or hepatic impairment
Patient refusal to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the pain scores and rescue analgesia requirement in patients receiving Tapentadol nasal spray and multimodal systemic analgesia in patients with multiple rib fractures  ENTIRE HOSPITAL STAY AND POST 7 DAY DISCHARGE 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the tolerability and side effects of the drugs used in two groups.
To compare the satisfaction scores of patients receiving two types of analgesia as well as treating surgeons
 
ENTIRE HOSPITAL STAY AND POST 7 DAY DISCHARGE 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   05/09/2025 
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  

Patients with chest trauma admitted through the emergency department will be managed as per ATLS guidelines, including resuscitation, stabilization, IV analgesics, intercostal nerve block, antibiotics, oxygen support and, if indicated intercostal chest drainage . After stabilization of patient and taking informed consent, they will be randomized by computer-generated numbers into two groups. Group A will receive Tapentadol nasal spray (22.5 mg per nostril, four times daily) along with intercostal nerve block . Group B will receive multimodal systemic analgesia (Tramadol, Paracetamol, Diclofenac in rotation) along with intercostal nerve block  as required. For initial 48 hours, Group A and Group B patients will receive blanket cover of intercostal nerve block (twice a day) and multimodal systemic analgesia /Tapentadol nasal spray. In both the groups, after 48 hours, rescue analgesia with injection diclofenac will be given whenever the pain score is >4. For assessment of pain VAS score is used, a 10-cm line marked on paper, with 0 meaning no pain and 10 denoting maximum pain will be used . Appropriate statistical test of significance will be used to study the differences between both the groups.

 
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