CTRI/2024/03/064850Not yet recruitingPhase 4
To evaluate the efficacy of pre-operative Intranasal Tapentadol spray on Postoperative pain in patients undergoing infraumblical surgeries under Spinal Anaesthesia -Randomised Controlled Study. - nil
Bangalore Medical College and Research Institute0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Patients who have given written informed consent.
- •2. Patients aged 18-60 years.
- •3. Sex- males and females.
- •4. Patients scheduled for elective infraumblical surgery under spinal
- •anesthesia.
- •5. Patients with ASA grade I & II.
Exclusion Criteria
- •1. Patients not willing to give consent and refusing to participate in the study.
- •2. Patients with any contraindications for neuraxial blockade.
- •3. Known allergy to any of the study medication.
- •4. Patient on Opioid dependence.
- •5. Patients who have taken any medication by intranasal route within the past 72
- •hours prior to randomization.
- •6. Patients with severe bronchial asthma, paralytic ileus, nasal allergy, upper
- •respiratory tract infection.
- •7. Patients with current history of psychiatric illness and being treated with
- •tricyclic antidepressants, selective serotonin reuptake inhibitors, selective
- •noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans,
- •monoamine oxidase inhibitors, steroids , a-2 agonists or opioid medications
- •within 28 days before scheduled surgery.
- •8. Patient with any end organ dysfunction.
- •9. Pregnancy.
- •10. Patient with history of alcohol abuse, smoking habit, drug abuse.
- •11. Uncontrolled cases of diabetes mellitus, hypertension, ischemic heart disease,
- •arrhythmias.
Investigators
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