Lower Limb FracturePhase 4NCT05999890
Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol
A Phase 4 study testing Tapentadol Hydrochloride in people with Lower Limb Fracture, run by Kempegowda Institute of Medical Sciences, Bangalore at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lower Limb Fracture
- What is being tested?
- Tapentadol Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jul 2021to 30 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1 \& 2
- Posted for elective lower limb orthopaedic surgeries
Who cannot join
- Sepsis at the site of injection
- Coagulopathy
- Patients with history of renal, hepatic, cardiovascular disease
- Patient on chronic opioid use
Trial locations and contacts
1 site in 1 country.
India1 site
Kempegowda Institute of Medical Sciences
Bangalore, Karnataka, 560004
About this study
Official title: A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'
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
Read the 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
- Conditions
- Lower Limb Fracture
- Being tested
- Tapentadol Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol HydrochlorideDrug
Also called Paracetamol
Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol | Experimental | 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 Receives: Drug: Tapentadol Hydrochloride |
| Paracetamol | Active comparator | 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. Receives: Drug: Tapentadol Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured with Visual analogue scale
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).
Measured: Every 12 hours after the intervention till about 72 hours after the intervention
Secondary outcomes (1)
The need for rescue analgesia
The need for the add on analgesic whenever the subjects request for the same
Measured: In the first 72 hours after the initiation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start5 Jul 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kempegowda Institute of Medical Sciences, Bangalore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Priyanka Suresh, Kempegowda Institute of Medical Sciences, Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999890
- Sponsor's protocol ID
- KIMS/IEC/A035/D/2021
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared; If needed only anonymised individual data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'
- ClinicalTrials.gov ID
- NCT05999890
- Acronym / sponsor ID
- KIMS/IEC/A035/D/2021
- Conditions
- Lower Limb Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kempegowda Institute of Medical Sciences, BangaloreOther government
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia
| Arm | Type | Receives |
|---|---|---|
| Tapentadol | Experimental | Drug: Tapentadol HydrochlorideTapentadol 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 |
| Paracetamol | Active comparator | Drug: Tapentadol HydrochlorideParacetamol 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status 1 \& 2
- Posted for elective lower limb orthopaedic surgeries
Key exclusion criteria (4 listed)
- Sepsis at the site of injection
- Coagulopathy
- Patients with history of renal, hepatic, cardiovascular disease
- Patient on chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapentadol HydrochlorideAlso: ParacetamolIntranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia | Drug | Paracetamol, Tapentadol |
Primary outcome
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).
1 secondary outcome
The need for rescue analgesia
Time frame: In the first 72 hours after the initiation of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No. Individual patient data will not be shared; If needed only anonymised individual data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tapentadol Hydrochloride in people with Lower Limb Fracture, run by Kempegowda Institute of Medical Sciences, Bangalore at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as measured with Visual analogue scale (time frame: Every 12 hours after the intervention till about 72 hours after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.