Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

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

Aim of the study to compare the analgesic efficacy of intranasal tapentadol nasal spray 44.5mg and intravenous paracetamol 1gm during postoperative period by Visual analogue scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries. 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. 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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Fracture
• Intervention / Treatment: Drug: Paracetamol; Drug: Tapentadol Hydrochloride

Detailed Description

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

1. Sepsis at the site of injection
2. Coagulopathy
3. Patients with history of renal, hepatic, cardiovascular disease
4. 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

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560004
      • Kempegowda Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) physical status 1 & 2 2. Posted for elective lower limb orthopaedic surgeries

Exclusion Criteria:

1. Sepsis at the site of injection
2. Coagulopathy
3. Patients with history of renal, hepatic, cardiovascular disease
4. Patient on chronic opioid use -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tapentadol; 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; Intranasal administration of tapentadol would be compared with intravenous paracetamol for postoperative analgesia
Active Comparator: Paracetamol; 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: Paracetamol; Paracetamol

What is the study measuring?

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 0-10 (score 0 = no pain, score 10 - most severe pain). Patients with a VAS score of more than 3, 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

Collaborators and Investigators

• Sponsor: Karnataka Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Acetaminophen; Tapentadol
• Other Study ID Numbers: KIMS/IEC/A035/D/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will not be shared; If needed only anonymised data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No