Lower Limb Fracture
Conditions
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
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
Interventions
Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia
Sponsors
Kempegowda Institute of Medical Sciences, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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
Intervention model description
It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Outcome results
None listed