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Completed

NCT Number: NCT05999890

Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

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

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Key information

Conditions

Lower Limb Fracture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kempegowda Institute of Medical Sciences

Bangalore, Karnataka, 560004, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tapentadol Hydrochloride

Drug

Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia

Other names: Paracetamol

Primary outcomes

  1. Pain as measured with Visual analogue scale

    Time frame: Every 12 hours after the intervention till about 72 hours after the intervention

    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).

Secondary outcomes

  1. The need for rescue analgesia

    Time frame: In the first 72 hours after the initiation of the intervention

    The need for the add on analgesic whenever the subjects request for the same

Sponsors and collaborators

Lead sponsor

Kempegowda Institute of Medical Sciences, Bangalore

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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