Health Condition 1: S829- Unspecified fracture of lower leg Health Condition 2: S899- Unspecified injury of lower leg
Conditions
Interventions
Intervention1: 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
Sponsors
Mahathma Gandhi Medical College and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the static and dynamic Pain scores (VNRS) at the end of 72hrs post-surgery.Timepoint: 72 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) Timepoint: 0,2,4,6,8,10,12,48 and 72 hrs | — |
Countries
India
Contacts
Public ContactAnnie Sheeba J
Mahatma Gandhi Medical College and Research Institute
Outcome results
None listed