| 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
|
|
|
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
|
|
|
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
|
|
|
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. |