Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

Lower Limb Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05967221
• Other study ID #: KIMS/IEC/A035/D/2021
• Status: Completed
• Phase: Phase 4
• Start date: July 5, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2023
• Source: Karnataka Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Lower Limb Fracture

Intervention

Drug:
• Tapentadol Hydrochloride
Intranasal administration of tapentadol would be compared with intravenous paracetamol for postoperative analgesia
• Paracetamol
Paracetamol

Locations

Country	Name	City	State
India	Kempegowda institute of medical sciences	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Karnataka Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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