Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: spinal Anaesthesia: Under strict aseptic conditions, spinal anesthesia will be administered in the left lateral position using 2.2 ml of 0.5 percent heavy levobupivacaine with a 26G Qui
Sponsors
SGRD
Eligibility
Inclusion criteria
Inclusion criteria: 1. American Society of Anesthesiologists (ASA) II 2. Singleton pregnancy 3. Patients willing to give consent for spinal anesthesia for elective LSCS.
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity to tapentadol and diclofenac. 2.History of drug allergy. 3.Active or suspected gastrointestinal ulcers, bleeding, or motility disorders within the past 6 months prior to screening. 4.Chorioamnionitis. 5.Recent intranasal medication within the 72 hours preceding randomization. 6.Bleeding diathesis, bleeding tendency or coagulation disorders. 7.Concurrent use of TCAs, SSRIs, SNRIs, anticonvulsants, neuroleptics, triptans,steroids, MAO inhibitors, or drugs with potential to lower seizure threshold inthe 4 weeks prior to enrolment. 8.History of alcoholism / drug abuse. 9.Medical disorders like seizures, gastric ulcers,bronchial asthma and COPD 10.Unable to rate their pain on scales used due to psychiatric reasons. 11.Hepatic/ renal/CVS/ pulmonary disease/ central or peripheral nervous systemdisease. 12.Mild to moderate traumatic brain injury, stroke, or brain neoplasm within thepast year or severe traumatic brain injury within the last 15 days. 13.Chronic abdominal pain. 14.On treatment with analgesics and anticoagulants. 15.Clinically significant ECG abnormalities or QTC more than or equal to 450 msec for males and more than or equal to 470 msec for females at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the analgesic efficacy of tapentadol administered through two routes for post operative pain management in elective LSCS.Timepoint: Postoperative vital signs will be monitored every 4 hours. Study medications will be given every 6 hours, and pain will be assessed using the visual analog scale (VAS) every 4 hours for 48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the side effects of drug & complications of routes of administration.Timepoint: Postoperative vital signs will be monitored every 4 hours. Study medications will be given every 6 hours, and pain will be assessed using the visual analog scale (VAS) every 4 hours for 48 hours. | — |
Countries
India
Contacts
Public ContactDr Bhavshereen Kaur
Sri Guru Ram Das Institute of Medical Sciences and Research
Outcome results
None listed