Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

Study Overview
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Brief Summary
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The aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries. Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode of action is responsible for its opioid-sparing effect, which contributes to a reduction in some of the typical opioid-related adverse effects

Detailed Description
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Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of Anesthesiologists (ASA) physical status: 1 & 2, posted for elective lower limb orthopedic surgeries Exclusion criteria Sepsis at the site of injection Coagulopathy Patients with history of renal, hepatic, cardiovascular disease Patient on chronic opioid use Outcome Comparing postoperative analgesia between the groups every 12 hours after the intervention till about 72 hours post intervention. The secondary outcome is to compare the need for the rescue analgesia between the groups

Official Title
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A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'

Conditions
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Lower Limb Fracture

Intervention / Treatment
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* Drug: Tapentadol Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1 & 2 Posted for elective lower limb orthopaedic surgeries Exclusion Criteria: Sepsis at the site of injection Coagulopathy Patients with history of renal, hepatic, cardiovascular disease Patient on chronic opioid use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tapentadol<br>Tapentadol is a novel, centrally acting analgesic with dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition.this dual mode of action is responsible for its opioid sparing effect, which contributes to reduction in some of the typical opioid related adverse effects | Drug: Tapentadol Hydrochloride<br>* Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia<br>* Other names: Paracetamol;|
| Active Comparator: Paracetamol<br>Paracetamol is one of the most frequently used analgesic and antipyretic agent, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDS. | Drug: Tapentadol Hydrochloride<br>* Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia<br>* Other names: Paracetamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured with Visual analogue scale | The pain rating was done as per a visual analogue scale (VAS) of 0-100 (score 0 = no pain, score 100 - most severe pain). Patients with a VAS score of more than 30, at what is considered as base line, in group A=received IV paracetamol 1gm given every 5-6 hourly and in group B=received intranasal tapentadol 44.5mg nasal spray administered every 5-6 hourly. Patient was assessed for pain by using VAS half an hour after administration and the scores were documented. Pain score were recorded at and after 30 minutes of the intervention in the following time frames - 12hr,24hr,36hr,48hr, 60hr and 72hrs after the baseline intervention (0hr). | Every 12 hours after the intervention till about 72 hours after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for rescue analgesia | The need for the add on analgesic whenever the subjects request for the same | In the first 72 hours after the initiation of the intervention |