AnalgesiaNCT03351517
Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty
A study testing Tapentadol 100 MG in people with Analgesia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
The study intends to evaluate the efficacy of Tapentadol against placebo as a preemptive analgesic in the management of post-operative pain in the patiens undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Tapentadol 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2017to 7 Sep 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex undergoing elective tota knee replacement surgery
- Patients are capable to provide an informed consent
- Age 18-65 years
Who cannot join
- Patients with Asthma, copd or any other respiratory disease
- Persistent nausea , vomiting at the time of randomization
- Treated with MAO inhibitors, Tricyclic antidepressants, SSRIs and SNRIs
- Patients with ASA grading 3 or more
- Drug abuse history, opioid tolerance or dependence, known history of opiod allergies
- Renal or liver disease
Show all 10Show fewer
- Major psychiatric disorder
- Pregnancy and lactation
- Emergency surgery
- Bone tumor, epilepsy or patients with migraine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty: A Randomized Double Blind Placebo-controlled Trial.
The study intends to evaluate the efficacy of Tapentadol against placebo as a preemptive analgesic in the management of post-operative pain in the patiens undergoing total knee arthroplasty.
The primary objective is to evaluate th epain score in visual analogue scale at various time points within 24 hours post operarively
Read the detailed description
METHODOLOGY
- Consent: Participants will be explained the benefit and harm of joining the study and the freedom of withdrawing from the study at any moment they would like to. A full voluntary written informed consent will be obtained from each participant. Study will be conducted following the principles of Helsinki after getting written permission of the institutional ethics committee. Before enrolment of first subject in this study registration for clinical trial will be done.
- Participants: Patients of either sex, above 18 yrs. of age undergoing Total Knee Arthroplasty will be the participants in this study.
- Inclusion Criteria:
- Patients both males and females undergoing elective total knee replacement surgery
- Patients are capable to provide an informed consent
- Age 18-75 yrs.
- Exclusion Criteria:
- Patients with Asthma, COPD or any other respiratory disease.
- Persistent nausea and vomiting at the time of randomization.
- Epilepsy.
- Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re uptake inhibitors.
- Patients with ASA grading 3 or more.
- Drug abuse history.
- Opioid tolerance or opioid dependence.
- Renal disease(creatinine>1.5 mg/dl).
- Liver disease (total bilirubin>1.5 mg/dl).
- Known history of opioid allergies.
- Major psychiatric disorder.
- Pregnancy and lactation.
- Emergency surgery.
- Bone tumor
- Migraine patients or patients complaining dizziness, vertigo.
Screening: The trial will be comprised of complete medical history and physical examination and screening. Pre-operative laboratory investigations will be recorded in case record form.
- Randomization: A total of 90 Participants will be selected by computer generated random list.
- Blinding: The study will be conducted in a double blinded manner.
- Treatment Administration and baseline follow up: The participants will be assigned to receive 100 mg of Tapentadol or a matched placebo orally 1 hr before spinal anesthesia in a double-blind manner. All the participants, both control and Tapentadol group will be anesthetized (SP) as per the standard protocol after similar pre-medication. Single dose of injection Paracetamol 1 gm i.v. will be provided in both the groups immediately after operation.
- Assessment of efficacy and safety and Duration: All the subjects will be assessed for pain at rest, before surgery, at 0, 6 12 \&, 24 hrs. post operatively by visual analogue scale score(VAS) (0 mm: no pain,100 mm: Worst pain imaginable).16 and TOTPAR SCALE(None-Mild-Moderate-Severe) *. They also will be evaluated for nausea, vomiting, drowsiness, and pruritus and will be rated on0,6,12, \& 24 hrs.16. Total rescue analgesic consumption also will be assessed at 24 hrs post operatively 16. The time of 1st request for supplemental analgesia also will be recorded. A blood sample will be obtained from each participant at 0 hrs. post operatively to measure the tapentadol concentration and Cholecystokinin by ELISA method.
- Conditions
- Analgesia
- Being tested
- Tapentadol 100 MG, Placebo Oral Tablet
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol 100 MGDrug
100 mg of oral extended release tapentadol will be given to the patients undergoing total knee replacement surgery on spinal anesthesia to evaluate its efficacy in the management of post-operative pain.
Placebo Oral TabletDrug
A matching placebo will be given to the patients undergoing total knee replacement surgery on spinal anesthesia to evaluate its efficacy in the management of post-operative pain.
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol arm | Experimental | Single dose of 100 mg of extended release oral tapentadol will be administered 1 hour before surgery. Receives: Drug: Tapentadol 100 MG |
| Placebo arm | Placebo comparator | A comparable placebo will be administered 1 hour before surgery. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Change of Pain score compared to plecebo by visual analogue scale
All the subjects will be assessed for pain at various time points post-operatively by visual analogue scale(VAS) (minimum value 00- no pain to maximum value-100 - worst pain imaginable) Higher values indicate worse outcome
Measured: 24 hrs. post-operatively( 0,2,4,6,12,24 hrs post operatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Nov 2017
- Primary completion20 Aug 2018
- Study completion7 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Debasish Hota, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- DEBASISH HOTA, MD,DM, Principal investigator, AIIMS Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351517
- Sponsor's protocol ID
- T/IM-NF/Pharma/02/17
- Status last verified
- Sep 2018
- First submitted
- 11 Nov 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty: A Randomized Double Blind Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT03351517
- Acronym / sponsor ID
- T/IM-NF/Pharma/02/17
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 7 Sep 2018 (actual)
- First posted
- 24 Nov 2017 (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 study intends to evaluate the efficacy of Tapentadol against placebo as a preemptive analgesic in the management of post-operative pain in the patiens undergoing total knee arthroplasty.
The primary objective is to evaluate th epain score in visual analogue scale at various time points within 24 hours post operarively
Detailed description
METHODOLOGY
- Consent: Participants will be explained the benefit and harm of joining the study and the freedom of withdrawing from the study at any moment they would like to. A full voluntary written informed consent will be obtained from each participant. Study will be conducted following the principles of Helsinki after getting written permission of the institutional ethics committee. Before enrolment of first subject in this study registration for clinical trial will be done.
- Participants: Patients of either sex, above 18 yrs. of age undergoing Total Knee Arthroplasty will be the participants in this study.
- Inclusion Criteria:
- Patients both males and females undergoing elective total knee replacement surgery
- Patients are capable to provide an informed consent
- Age 18-75 yrs.
- Exclusion Criteria:
- Patients with Asthma, COPD or any other respiratory disease.
- Persistent nausea and vomiting at the time of randomization.
- Epilepsy.
- Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re uptake inhibitors.
- Patients with ASA grading 3 or more.
- Drug abuse history.
- Opioid tolerance or opioid dependence.
- Renal disease(creatinine>1.5 mg/dl).
- Liver disease (total bilirubin>1.5 mg/dl).
- Known history of opioid allergies.
- Major psychiatric disorder.
- Pregnancy and lactation.
- Emergency surgery.
- Bone tumor
- Migraine patients or patients complaining dizziness, vertigo.
Screening: The trial will be comprised of complete medical history and physical examination and screening. Pre-operative laboratory investigations will be recorded in case record form.
- Randomization: A total of 90 Participants will be selected by computer generated random list.
- Blinding: The study will be conducted in a double blinded manner.
- Treatment Administration and baseline follow up: The participants will be assigned to receive 100 mg of Tapentadol or a matched placebo orally 1 hr before spinal anesthesia in a double-blind manner. All the participants, both control and Tapentadol group will be anesthetized (SP) as per the standard protocol after similar pre-medication. Single dose of injection Paracetamol 1 gm i.v. will be provided in both the groups immediately after operation.
- Assessment of efficacy and safety and Duration: All the subjects will be assessed for pain at rest, before surgery, at 0, 6 12 \&, 24 hrs. post operatively by visual analogue scale score(VAS) (0 mm: no pain,100 mm: Worst pain imaginable).16 and TOTPAR SCALE(None-Mild-Moderate-Severe) *. They also will be evaluated for nausea, vomiting, drowsiness, and pruritus and will be rated on0,6,12, \& 24 hrs.16. Total rescue analgesic consumption also will be assessed at 24 hrs post operatively 16. The time of 1st request for supplemental analgesia also will be recorded. A blood sample will be obtained from each participant at 0 hrs. post operatively to measure the tapentadol concentration and Cholecystokinin by ELISA method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tapentadol arm | Experimental | Drug: Tapentadol 100 MGSingle dose of 100 mg of extended release oral tapentadol will be administered 1 hour before surgery. |
| Placebo arm | Placebo comparator | Drug: Placebo Oral TabletA comparable placebo will be administered 1 hour before surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either sex undergoing elective tota knee replacement surgery
- Patients are capable to provide an informed consent
- Age 18-65 years
Key exclusion criteria (10 listed)
- Patients with Asthma, copd or any other respiratory disease
- Persistent nausea , vomiting at the time of randomization
- Treated with MAO inhibitors, Tricyclic antidepressants, SSRIs and SNRIs
- Patients with ASA grading 3 or more
- Drug abuse history, opioid tolerance or dependence, known history of opiod allergies
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 100 MG100 mg of oral extended release tapentadol will be given to the patients undergoing total knee replacement surgery on spinal anesthesia to evaluate its efficacy in the management of post-operative pain. | Drug | Tapentadol arm |
| Placebo Oral TabletA matching placebo will be given to the patients undergoing total knee replacement surgery on spinal anesthesia to evaluate its efficacy in the management of post-operative pain. | Drug | Placebo arm |
Primary outcome
Assessment of Change of Pain score compared to plecebo by visual analogue scale
Time frame: 24 hrs. post-operatively( 0,2,4,6,12,24 hrs post operatively)
All the subjects will be assessed for pain at various time points post-operatively by visual analogue scale(VAS) (minimum value 00- no pain to maximum value-100 - worst pain imaginable) Higher values indicate worse outcome
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 10 Sep 2018.
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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.
DEBASISH HOTA, MD,DM principal investigator
AIIMS Bhubaneswar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tapentadol 100 MG in people with Analgesia, run by All India Institute of Medical Sciences, Bhubaneswar 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 3 inclusion and 10 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 10 Sep 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Assessment of Change of Pain score compared to plecebo by visual analogue scale (time frame: 24 hrs. post-operatively( 0,2,4,6,12,24 hrs post operatively)). 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 10 Sep 2018.