| 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
|
|
|
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
|
|
|
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. |