Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

Sponsor

Kempegowda Institute of Medical Sciences, Bangalore (Other)

Overall Status

Completed

CT.gov ID

NCT05999890

Collaborator

(none)

Enrollment

Location

Arms

5.8

Actual Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lower Limb Fracture	Drug: Tapentadol Hydrochloride	Phase 4

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesiaIt is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia

Masking:

Single (Outcomes Assessor)

Masking Description:

Single (Outcomes Assessor) The assessor of the outcome would measure hemodynamic parameters and severity of the pain at the mentioned time intervals. The assessor was not involved in the randomization / administration of the intervention

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 5, 2021

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

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 was compared with intravenous paracetamol for postoperative analgesia Other Names: Paracetamol
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: Tapentadol Hydrochloride Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia Other Names: Paracetamol

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 was compared with intravenous paracetamol for postoperative analgesia

Other Names:

Paracetamol

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: Tapentadol Hydrochloride

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

Other Names:

Paracetamol

Outcome Measures

Primary Outcome Measures

Pain as measured with Visual analogue scale [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 Outcome Measures

The need for rescue analgesia [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kempegowda Institute of Medical Sciences	Bangalore	Karnataka	India	560004

Sponsors and Collaborators

Kempegowda Institute of Medical Sciences, Bangalore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Priyanka Suresh, Assistant Professor, Kempegowda Institute of Medical Sciences, Bangalore

ClinicalTrials.gov Identifier:

NCT05967221

Other Study ID Numbers:

KIMS/IEC/A035/D/2021
NCT05967221

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tapentadol

Study Results

No Results Posted as of Aug 21, 2023