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CTRI Number  CTRI/2026/01/101653 [Registered on: 20/01/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of a Nasal Spray Pain Medication for Patients Undergoing Lower Limb Orthopaedic Surgery 
Scientific Title of Study   Comparison of analgesic efficacy of intranasal tapentadol for lower limb orthopaedic surgeries - A Randomised Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yadhu Nandhan G 
Designation  Post graduate 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology, 2nd floor,Hospital block Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam.

Pondicherry
PONDICHERRY
607403
India 
Phone  9626566676  
Fax    
Email  yadhugnandhan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Annie Sheeba J 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology, 2nd floor, Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam.

Pondicherry
PONDICHERRY
607403
India 
Phone  9655035791  
Fax    
Email  dr.anniej@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Annie Sheeba J 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology, 2nd floor, Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam.

Pondicherry
PONDICHERRY
607403
India 
Phone  9655035791  
Fax    
Email  dr.anniej@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mahathma Gandhi Medical College and Research Institute 
Address  Pillaiyarkuppam, Cuddalore Main Road, Puducherry - 607402,  
Type of Sponsor  Private medical college 
 
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 Yadhu Nandhan G  Mahatma gandhi medical college and reasearch institute,  Department of anaesthesiology, 2nd floor,Hospital Block Mahatma gandhi medical college and reasearch institute Pillaiyarkuppam
Pondicherry
PONDICHERRY 
9626566676

yadhugnandhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S829||Unspecified fracture of lower leg, (2) ICD-10 Condition: S899||Unspecified injury of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group NS  0.9% normal saline 2 sprays 0.1ml in the same nostril for each dose (1ml) twice daily from postoperative day 0 to postoperative day 3. IV Paracetamol 15 mg/kg (max 4g), every 8 hours (three times daily) and IV Ketorolac 30mg every 12 hours (two times daily).  
Intervention  Group Tp   Intranasal Tapentadol group: Intranasal Tapentadol two sprays (22.5mg per spray) in the same nostril for each dose (total dose: 45mg), twice daily from postoperative day 0 to postoperative day 3. IV Paracetamol 15 mg/kg (max 4g), every 8 hours (three times daily) and IV Ketorolac 30mg every 12 hours (two times daily).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients aged 18–70 years

ASA Physical Status I–II

Undergoing elective lower limb orthopedic surgery under spinal anesthesia

Able to understand and use the Verbal Numerical Rating Scale (VNRS) for pain

Provided written informed consent.
 
 
ExclusionCriteria 
Details  Chronic opioid use or history of substance abuse.
Nasal pathology (e.g., deviated septum, nasal polyps, frequent epistaxis).
Patients with significant renal or hepatic impairment.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the static and dynamic Pain scores (VNRS) at the end of 72hrs post-surgery.  72 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the static and dynamic pain score at 0,2,4,6,8,10,12,48 and 72 hours post-surgery using VNRS.

To assess and compare the total number of breakthrough pain episodes and the rescue analgesia used.

To assess and compare the total amount of tramadol used.

To assess and compare the incidence of complication (nausea, vomiting, sedation, respiratory depression, dizziness, nasal irritation)
 
0,2,4,6,8,10,12,48 and 72 hrs 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   02/03/2026 
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="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 randomized, double-blind, placebo-controlled, parallel-group clinical trial will be conducted at Mahatma Gandhi Medical College Hospital and Research Institute, Sri Balaji Vidyapeeth. 

Patients will be randomly allocated in a 1:1 ratio to one of the two treatment groups determined by a computer-generated random sequence. This gives all the patients equal (50/50) chance of being placed in either group. This reduces bias and ensures fair comparison of the treatment being studied. The study will be conducted in a single-blind manner, wherein the patients will be blinded to their group allocation, while the investigators and clinical staff will be not blinded. To maintain blinding at the patient level, identical-appearing intranasal spray devices containing either Tapentadol 22.5 mg per nostril (Group TP) or normal saline (Group NS), ensuring similarity in appearance, volume, and administration technique. Pain assessments will be conducted by an independent obese to treatment allocation to minimize assessment bias.

Groups P : (STANDARD ANALGESIC REGIME)

This group will receive Intravenous Paracetamol 15mg/kg, thrice daily (not exceeding 4g/day) + Inj.Ketorolac IV 30mg twice daily + Intranasal normal saline 2 sprays 0.1ml in the same nostril for each dose (1ml) twice daily from postoperative day 0 to  postoperative day 3.

GROUP TP : (Intranasal Tapentadol group)

This group will receive Intravenous Paracetamol 15mg/kg, thrice daily (not exceeding 4g/day) + Inj.Ketorolac IV 30mg twice daily + Intranasal Tapentadol two sprays (i.e.) 22.5mg per spray in the same nostril for each dose (45mg), twice daily from postoperative day 0 to postoperative day 3.

After obtaining approval from the Institutional Research Committee and Institutional Ethics Committee, patients fulfilling inclusion criteria will be recruited for the study and informed consent will be obtained. Patient will be educated about the study protocol and how to express VNRS for level of pain. Patient’s demographic details- Age, co-morbidities, surgical data will be documented. Patients will be randomly allocated (1:1) into either Group NS or Group Tp.

On the day of surgery patient will receive spinal anaesthesia with 0.5% hyperbaric bupivacaine plus 60mcg of buprenorphine (volume of LA based on patients demography) as per the primary OT anaesthesiologist.

Duration of surgery, intraoperative blood loss, intraoperative adverse events such as arrythmias, hypotension will be documented.

At the end of surgery, patient will be shifted to postoperative care unit (PACU). Sensory blockade level will be assessed. When the patient complains of a VNRS- static > 3, patient will receive the first dose of Intravenous Paracetamol and assessed after 30 mins, if the VNRS  is >3 persistently then Intravenous Tramadol (1mg/kg) is administered. End of 6 hours after receiving paracetamol, patients will receive intranasal saline/ tapentadol based on their group allocation and repeated every 12 hours .Patient will be assessed 30 mins post spray for pain relief and tabulated in VNRS.

 
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