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CTRI Number  CTRI/2026/02/103498 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Comparison of Intranasal Tapentadol and Intravenous Tramadol for Pain Relief After Lower Limb Orthopaedic Surgery Under Spinal Anaesthesia 
Scientific Title of Study   Comparison Of Intrasnasal Tapentadol Versus Intravenous Tramadol For Post Operative Analgesia In Lower Limb Orthopedic Surgeries 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  Bhuvaneswari prasad k 
Designation  First year Pg md anesthesiology  
Affiliation  Kshegde medical academy  
Address  Department of anesthesiology first floor kshegde hospital deralakatte manglore
Kshegde medical academy
Dakshina Kannada
KARNATAKA
533106
India 
Phone  8247731185  
Fax    
Email  kbhuvana4397@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Govindraj bhat 
Designation  Associate professor department of Anesthesiology  
Affiliation  K S Hegde medical academy  
Address  Department of anesthesiology first floor kshegde hospital deralakatte manglore
K S Hegde medical academy
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9343561152  
Fax    
Email  govindrajbhat@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Bhuvaneswari prasad k 
Designation  First year Pg md anesthesiology  
Affiliation  Kshegde medical academy  
Address  Department of anesthesiology first floor kshegde hospital deralakatte manglore
Kshegde medical academy

KARNATAKA
533106
India 
Phone  8247731185  
Fax    
Email  kbhuvana4397@gmail.com  
 
Source of Monetary or Material Support  
Justice K S Hegde Hospital, Nithyananda nagar, Deralakatte, Manglore, Dakshina Kannada district, 575018 Karnataka, India  
 
Primary Sponsor  
Name  Justice K S Hegde Hospital 
Address  Deralakatte manglore 575018 
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 
Bhuvaneswari prasad k  Kshegde medical academy   1st floor, PACU, Department of Anesthesiology and critical care, Justice K S Hegde Charitable Hospital, Deralakatte manglore 575018
Dakshina Kannada
KARNATAKA 		 08247731185

kbhuvana4397@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethnics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention   Intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Asa physical status classification grade 1 to 3
Patients undergoing elective lower limb orthopedic surgeries under spinal anaesthesia  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess reduction in pain scores following Tapentadol Nasal Spray and IV Tramadol for Postoperative pain management following lower limb orthopaedic surgeries  1hr ,2hr,4hr,6hrs for first 6hrs and every 6hrs for 48hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To assess adverse effects, the impact on early mobilization & patient satisfaction after 48hrs
 		 At & after 48hrs  
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   01/03/2026 
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="1"
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   The study titled “Comparison of Intranasal Tapentadol versus Intravenous Tramadol for Postoperative Analgesia in Lower Limb Orthopaedic Surgeries under Spinal Anaesthesia” is a prospective observational study aimed at evaluating the effectiveness of intranasal tapentadol compared to intravenous tramadol in controlling postoperative pain.

Background: Postoperative pain management is crucial for faster recovery and early mobilization. Tapentadol offers potent analgesia with fewer side effects due to its dual mechanism of action. Intranasal delivery provides rapid onset and better bioavailability.

Aim: To compare the analgesic efficacy of intranasal tapentadol nasal spray and intravenous tramadol.

Objectives:

Primary: To assess reduction in pain scores.

Secondary: To evaluate adverse effects, early mobilization, and patient satisfaction.


Methods:

Conducted at K.S. Hegde Medical Academy (2025–2027).

Sample size: 86 patients.

Inclusion: Adults (18–60 yrs) undergoing elective lower limb orthopedic surgeries under spinal anesthesia.

Two groups: Tapentadol NS vs IV Tramadol.

Pain scores assessed using VAS at multiple intervals up to 48 hours.

Adverse effects and rescue analgesic use monitored.


Statistical Analysis: Unpaired t-test, Mann–Whitney U, Chi-square, significance set at p < 0.05.


 Expected Outcome: Intranasal tapentadol is anticipated to provide faster onset, better pain control, fewer side effects, and improved early mobilization compared to IV tramadol.
 
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