Osteoarthritis, KneePhase 4NCT03604354
Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery
A Phase 4 study testing Tapentadol 100 MG Oral Tablet and Pregabalin 150mg in people with Osteoarthritis, Knee, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
Preemptive analgesia is a treatment modality which starts even before the surgery, so that the central sensitization is prevented due to incisional injury at the time of surgery, so it covers the period of surgery and initial post-operative period preventing the development of central sensitization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Tapentadol 100 MG Oral Tablet and Pregabalin 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2018to 19 May 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients both males and females undergoing total knee arthroplasty surgery. 2. Patients are capable of providing an informed consent. 3. Age group between 18-75 years.
Who cannot join
- 1.Patients with asthma, COPD or any other respiratory disease. 2. Persistent nausea and vomiting at time of randomization 3. Epilepsy. 4. Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re-uptake inhibitors, gabapentinoids.
- 5. Patient with known neurological/ neuropsychiatric disorders. 6. Drug or alcohol abuse history 7. Opioid tolerance or opioid dependence. 8. Known history of opioid allergy or pregabalin allergy. 9. Renal disease (creatinine >1.5mg/dl) 10. Liver disease (total bilirubin >1.5mg/dl) 11. Pregnancy and lactation. 12. Cardiovascular insufficiency. 13. Patient with potential serotonin syndrome. 14. Patient with history of constipation and prone to paralytic ileus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Unilateral Total Knee Arthroplasty- A Randomised, Double Blind, Active Control, Clinical Trial
Preemptive analgesia is a treatment modality which starts even before the surgery, so that the central sensitization is prevented due to incisional injury at the time of surgery, so it covers the period of surgery and initial post-operative period preventing the development of central sensitization.
Gabapentinoid compounds are gabapentin and pregabalin which have been extensively used in seizure disorder patient. Role of gabapentinoid compounds in the management of pain, as a pre-emptive analgesia is yet to be completely evaluated in post operative pain. Opioids have always been the preferred drugs to manage post operative pain. Since opioids have major side effects of nausea vomiting associated with its treatment their use comes with management of these side effects.
Read more
Currently, diagnostic and therapeutic approaches to manage pain experienced by individuals are limited especially because there's a lack of bio-markers predictive of therapeutic outcome. In search of an objective method for pain measurement, as pain has always been subjective and it is perceived by different people differently the study will also include finding the use of COX(cyclo-oxygenase)-2 as a bio-marker of pain in post-operative patients.
Although several randomized clinical trials and met-analyses have been conducted comparing the safety and efficacy of tapentadol or pregabalin in post-operative pain, there is no head to head clinical trial conducted comparing the preemptive use of two drugs for postoperative pain following total knee arthroplasty (TKA). Hence the present study is planned.
Read the detailed description
MATERIALS AND METHODS
After approval of the institutional Ethics committee board, written informed consent will be taken from all the eligible and willing patients.
- Study design: Randomized double blind active controlled parallel group noninferiority clinical trial.
- Randomization: A variable block randomization. The allocation ratio will be 1:1 ratio between two interventions arms i.e. tapentadol 100 mg(milligram) and pregabalin 150 mg(milligram) orally.
- Allocation concealment: This study will be participant and investigator blinded. Allocation concealment will be done by sequentially numbered sealed drug pouches.
- Study site: Department of Pharmacology and Orthopedics of AIIMS, Bhubaneswar.
Selection Criteria
- Inclusion criteria
- Patients both males and females undergoing total knee arthroplasty surgery.
- Patients are capable of providing an informed consent.
- Age group between 18-75 years.
- Exclusion criteria
- Patients with asthma, COPD(Chronic obstructive pulmonary disease) or any other respiratory disease.
- Persistent nausea and vomiting at time of randomization
- Epilepsy.
- Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re-uptake inhibitors, gabapentinoids.
- Patient with known neurological/ neuropsychiatric disorders.
- Drug or alcohol abuse history
- Opioid tolerance or opioid dependence.
- Known history of opioid allergy or pregabalin allergy.
- Renal disease (creatinine >1.5mg/dl)
- Liver disease (total bilirubin >1.5mg/dl)
- Pregnancy and lactation.
- Cardiovascular insufficiency.
- Patient with potential serotonin syndrome.
- Patient with history of constipation and prone to paralytic ileus.
Study procedure, tools \& evaluation
- Consent: Patients will be explained the benefit and harm of joining the study and freedom of withdrawing from the study any moment they would like to. A full voluntary written informed consent will be obtained from each patient. Study will be conducted following the principles of Helsinki after getting written permission of the institutional ethics committee. Before enrolment of first patient in this study registration for clinical trial will be done.
- All the patients will be screened before enrollment after eliciting detailed history they will undergo complete medical and laboratory examinations.
- A total of 90 patients of either sex will be selected randomly and will be assigned to receive 100 mg of Tapentadol or 150mg Pregabalin orally 1hr before surgery in a double-blind manner. The patient will be assessed for pain at 0,6,12, and 24hrs, post operatively by visual analogue scale score(VAS) (0-100). Pain measurements will also be done on TOTPAR scale at 0,6,12,24 hours. Total rescue analgesic consumption also will be assessed at 24hrs post operatively. All treatment emergent adverse events will be documented. The time to 1st patient request for supplemental analgesia also will be recorded.
- A blood sample will be obtained from each of the patients twice once at 0 hrs. and again at 6hrs post operatively to evaluate concentration of COX-2 levels by ELISA with commercially available ELISA kits.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Tapentadol 100 MG Oral Tablet, Pregabalin 150mg
- Keywords
- OA knee,pre-emptive analgesia,TKA,Opioids,gabapentinoids
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol 100 MG Oral TabletDrug
This arm will receive drugs one hour before undergoing unilateral total knee arthroplasty. Interventions tapentadol 100mg oral tablets.
Pregabalin 150mgDrug
This arm will receive drugs one hour before undergoing unilateral total knee arthroplasty. Interventions pregabalin 150mg oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Pregabalin 150mg oral tablets before one hour before undergoing unilateral total knee arthroplasty Receives: Drug: Pregabalin 150mg |
| Tapentadol | Experimental | tapentadol 100mg oral tablets before one hour before undergoing unilateral total knee arthroplasty Receives: Drug: Tapentadol 100 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of pregabalin and tapentadol by measuring the mean difference in the mean VAS score.
Visual analogue scale (VAS) from 0 to 100 mm score at 0,6,12,24 hrs. post operatively in both the groups.
Measured: Evaluated over 24hrs post unilateral total knee arthroplasty
Secondary outcomes (6)
Comparing differences in TOTPAR scale through different time points of 24 hours Comparing differences in TOTPAR (none, mild, moderate and severe) scale through different time points of 24 hours
Scoring on TOTPAR scale at 0,6,12,24 hrs. post operatively in both the groups
Measured: Recorded over 24hrs post unilateral total knee arthroplasty
Measuring the rescue analgesic requirement in both the groups
Mean difference in total analgesic consumption in both the groups post operatively
Measured: Recorded over 24hrs post unilateral total knee arthroplasty
Monitoring adverse events in both the groups including post-operative nausea vomiting (PONV)
Frequency of nausea and vomiting in both the groups.
Measured: Recorded over 24hrs post unilateral total knee arthroplasty
Percentage of adverse events in a 4-point verbal scale.
On a scale (None, Mild, Moderate, Severe) in both the groups.
Measured: Recorded over 24hrs post unilateral total knee arthroplasty
Estimation of COX-2 at 0hrs and 6hrs post operatively in both the groups by ELISA.
Estimated in both the groups by ELISA.
Measured: In two blood samples one at 0hrs and 6hrs post operatively
Reduction of VAS and nausea/vomiting
Reduction of VAS to 3 at the end of 6 hours and 12 hours without nausea and vomiting
Measured: Evaluated at the end of 6 hours and 12 hours without nausea and vomiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Aug 2018
- Primary completion24 Mar 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 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
- NCT03604354
- Sponsor's protocol ID
- IEC/AIIMSBBSR/PGTH/18/12
- Status last verified
- Jun 2020
- First submitted
- 19 Jul 2018
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noah NM, Mwilu SK, Sadik OA, Fatah AA, Arcilesi RD. Immunosensors for quantifying cyclooxygenase 2 pain biomarkers. Clin Chim Acta. 2011 Jul 15;412(15-16):1391-8. doi: 10.1016/j.cca.2011.04.017. Epub 2011 Apr 17.
PubMed 21530501Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.
PubMed 17578977Kissin I. Preemptive analgesia. Anesthesiology. 2000 Oct;93(4):1138-43. doi: 10.1097/00000542-200010000-00040. No abstract available.
PubMed 11020772Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.
PubMed 24436674Pogatzki-Zahn EM, Segelcke D, Schug SA. Postoperative pain-from mechanisms to treatment. Pain Rep. 2017 Mar 15;2(2):e588. doi: 10.1097/PR9.0000000000000588. eCollection 2017 Mar.
PubMed 29392204Harsoor S. Emerging concepts in post-operative pain management. Indian J Anaesth. 2011 Mar;55(2):101-3. doi: 10.4103/0019-5049.79872. No abstract available.
PubMed 21712862Jain P, Jolly A, Bholla V, Adatia S, Sood J. Evaluation of efficacy of oral pregabalin in reducing postoperative pain in patients undergoing total knee arthroplasty. Indian J Orthop. 2012 Nov;46(6):646-52. doi: 10.4103/0019-5413.104196.
PubMed 23325966Dahl JB, Moiniche S. Pre-emptive analgesia. Br Med Bull. 2004 Dec 13;71:13-27. doi: 10.1093/bmb/ldh030. Print 2004.
PubMed 15596866Meacham K, Shepherd A, Mohapatra DP, Haroutounian S. Neuropathic Pain: Central vs. Peripheral Mechanisms. Curr Pain Headache Rep. 2017 Jun;21(6):28. doi: 10.1007/s11916-017-0629-5.
PubMed 28432601Rosero EB, Joshi GP. Preemptive, preventive, multimodal analgesia: what do they really mean? Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):85S-93S. doi: 10.1097/PRS.0000000000000671.
PubMed 25255012American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PubMed 22227789Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
PubMed 8346839Silverman RB. From basic science to blockbuster drug: the discovery of Lyrica. Angew Chem Int Ed Engl. 2008;47(19):3500-4. doi: 10.1002/anie.200704280. No abstract available.
PubMed 18307181Wang YM, Xia M, Shan N, Yuan P, Wang DL, Shao JH, Ma HW, Wang LL, Zhang Y. Pregabalin can decrease acute pain and postoperative nausea and vomiting in hysterectomy: A meta-analysis. Medicine (Baltimore). 2017 Aug;96(31):e7714. doi: 10.1097/MD.0000000000007714.
PubMed 28767611Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009 Feb;31(2):260-71. doi: 10.1016/j.clinthera.2009.02.009.
PubMed 19302899
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Unilateral Total Knee Arthroplasty- A Randomised, Double Blind, Active Control, Clinical Trial
- ClinicalTrials.gov ID
- NCT03604354
- Acronym / sponsor ID
- IEC/AIIMSBBSR/PGTH/18/12
- Conditions
- Osteoarthritis, Knee
- Keywords
- OA knee,pre-emptive analgesia,TKA,Opioids,gabapentinoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 27 Jul 2018 (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.
Preemptive analgesia is a treatment modality which starts even before the surgery, so that the central sensitization is prevented due to incisional injury at the time of surgery, so it covers the period of surgery and initial post-operative period preventing the development of central sensitization.
Gabapentinoid compounds are gabapentin and pregabalin which have been extensively used in seizure disorder patient. Role of gabapentinoid compounds in the management of pain, as a pre-emptive analgesia is yet to be completely evaluated in post operative pain. Opioids have always been the preferred drugs to manage post operative pain. Since opioids have major side effects of nausea vomiting associated with its treatment their use comes with management of these side effects.
Currently, diagnostic and therapeutic approaches to manage pain experienced by individuals are limited especially because there's a lack of bio-markers predictive of therapeutic outcome. In search of an objective method for pain measurement, as pain has always been subjective and it is perceived by different people differently the study will also include finding the use of COX(cyclo-oxygenase)-2 as a bio-marker of pain in post-operative patients.
Although several randomized clinical trials and met-analyses have been conducted comparing the safety and efficacy of tapentadol or pregabalin in post-operative pain, there is no head to head clinical trial conducted comparing the preemptive use of two drugs for postoperative pain following total knee arthroplasty (TKA). Hence the present study is planned.
Detailed description
MATERIALS AND METHODS
After approval of the institutional Ethics committee board, written informed consent will be taken from all the eligible and willing patients.
- Study design: Randomized double blind active controlled parallel group noninferiority clinical trial.
- Randomization: A variable block randomization. The allocation ratio will be 1:1 ratio between two interventions arms i.e. tapentadol 100 mg(milligram) and pregabalin 150 mg(milligram) orally.
- Allocation concealment: This study will be participant and investigator blinded. Allocation concealment will be done by sequentially numbered sealed drug pouches.
- Study site: Department of Pharmacology and Orthopedics of AIIMS, Bhubaneswar.
Selection Criteria
- Inclusion criteria
- Patients both males and females undergoing total knee arthroplasty surgery.
- Patients are capable of providing an informed consent.
- Age group between 18-75 years.
- Exclusion criteria
- Patients with asthma, COPD(Chronic obstructive pulmonary disease) or any other respiratory disease.
- Persistent nausea and vomiting at time of randomization
- Epilepsy.
- Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re-uptake inhibitors, gabapentinoids.
- Patient with known neurological/ neuropsychiatric disorders.
- Drug or alcohol abuse history
- Opioid tolerance or opioid dependence.
- Known history of opioid allergy or pregabalin allergy.
- Renal disease (creatinine >1.5mg/dl)
- Liver disease (total bilirubin >1.5mg/dl)
- Pregnancy and lactation.
- Cardiovascular insufficiency.
- Patient with potential serotonin syndrome.
- Patient with history of constipation and prone to paralytic ileus.
Study procedure, tools \& evaluation
- Consent: Patients will be explained the benefit and harm of joining the study and freedom of withdrawing from the study any moment they would like to. A full voluntary written informed consent will be obtained from each patient. Study will be conducted following the principles of Helsinki after getting written permission of the institutional ethics committee. Before enrolment of first patient in this study registration for clinical trial will be done.
- All the patients will be screened before enrollment after eliciting detailed history they will undergo complete medical and laboratory examinations.
- A total of 90 patients of either sex will be selected randomly and will be assigned to receive 100 mg of Tapentadol or 150mg Pregabalin orally 1hr before surgery in a double-blind manner. The patient will be assessed for pain at 0,6,12, and 24hrs, post operatively by visual analogue scale score(VAS) (0-100). Pain measurements will also be done on TOTPAR scale at 0,6,12,24 hours. Total rescue analgesic consumption also will be assessed at 24hrs post operatively. All treatment emergent adverse events will be documented. The time to 1st patient request for supplemental analgesia also will be recorded.
- A blood sample will be obtained from each of the patients twice once at 0 hrs. and again at 6hrs post operatively to evaluate concentration of COX-2 levels by ELISA with commercially available ELISA kits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: Pregabalin 150mgPregabalin 150mg oral tablets before one hour before undergoing unilateral total knee arthroplasty |
| Tapentadol | Experimental | Drug: Tapentadol 100 MG Oral Tablettapentadol 100mg oral tablets before one hour before undergoing unilateral total knee arthroplasty |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients both males and females undergoing total knee arthroplasty surgery. 2. Patients are capable of providing an informed consent. 3. Age group between 18-75 years.
Key exclusion criteria (2 listed)
- 1.Patients with asthma, COPD or any other respiratory disease. 2. Persistent nausea and vomiting at time of randomization 3. Epilepsy. 4. Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re-uptake inhibitors, gabapentinoids.
- 5. Patient with known neurological/ neuropsychiatric disorders. 6. Drug or alcohol abuse history 7. Opioid tolerance or opioid dependence. 8. Known history of opioid allergy or pregabalin allergy. 9. Renal disease (creatinine >1.5mg/dl) 10. Liver disease (total bilirubin >1.5mg/dl) 11. Pregnancy and lactation. 12. Cardiovascular insufficiency. 13. Patient with potential serotonin syndrome. 14. Patient with history of constipation and prone to paralytic ileus.
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 MG Oral TabletThis arm will receive drugs one hour before undergoing unilateral total knee arthroplasty. Interventions tapentadol 100mg oral tablets. | Drug | Tapentadol |
| Pregabalin 150mgThis arm will receive drugs one hour before undergoing unilateral total knee arthroplasty. Interventions pregabalin 150mg oral tablets. | Drug | Pregabalin |
Primary outcome
Efficacy and safety of pregabalin and tapentadol by measuring the mean difference in the mean VAS score.
Time frame: Evaluated over 24hrs post unilateral total knee arthroplasty
Visual analogue scale (VAS) from 0 to 100 mm score at 0,6,12,24 hrs. post operatively in both the groups.
6 secondary outcomes
Comparing differences in TOTPAR scale through different time points of 24 hours Comparing differences in TOTPAR (none, mild, moderate and severe) scale through different time points of 24 hours
Time frame: Recorded over 24hrs post unilateral total knee arthroplasty
Measuring the rescue analgesic requirement in both the groups
Time frame: Recorded over 24hrs post unilateral total knee arthroplasty
Monitoring adverse events in both the groups including post-operative nausea vomiting (PONV)
Time frame: Recorded over 24hrs post unilateral total knee arthroplasty
Percentage of adverse events in a 4-point verbal scale.
Time frame: Recorded over 24hrs post unilateral total knee arthroplasty
Estimation of COX-2 at 0hrs and 6hrs post operatively in both the groups by ELISA.
Time frame: In two blood samples one at 0hrs and 6hrs post operatively
Reduction of VAS and nausea/vomiting
Time frame: Evaluated at the end of 6 hours and 12 hours without nausea and vomiting
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 25 Jun 2020.
- Background: PubMed 21530501Noah NM, Mwilu SK, Sadik OA, Fatah AA, Arcilesi RD. Immunosensors for quantifying cyclooxygenase 2 pain biomarkers. Clin Chim Acta. 2011 Jul 15;412(15-16):1391-8. doi: 10.1016/j.cca.2011.04.017. Epub 2011 Apr 17.
- Results publication: PubMed 17578977Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.
- Results publication: PubMed 11020772Kissin I. Preemptive analgesia. Anesthesiology. 2000 Oct;93(4):1138-43. doi: 10.1097/00000542-200010000-00040. No abstract available.
- Results publication: PubMed 24436674Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.
- Results publication: PubMed 29392204Pogatzki-Zahn EM, Segelcke D, Schug SA. Postoperative pain-from mechanisms to treatment. Pain Rep. 2017 Mar 15;2(2):e588. doi: 10.1097/PR9.0000000000000588. eCollection 2017 Mar.
- Results publication: PubMed 21712862Harsoor S. Emerging concepts in post-operative pain management. Indian J Anaesth. 2011 Mar;55(2):101-3. doi: 10.4103/0019-5049.79872. No abstract available.
- Results publication: PubMed 23325966Jain P, Jolly A, Bholla V, Adatia S, Sood J. Evaluation of efficacy of oral pregabalin in reducing postoperative pain in patients undergoing total knee arthroplasty. Indian J Orthop. 2012 Nov;46(6):646-52. doi: 10.4103/0019-5413.104196.
- Results publication: PubMed 15596866Dahl JB, Moiniche S. Pre-emptive analgesia. Br Med Bull. 2004 Dec 13;71:13-27. doi: 10.1093/bmb/ldh030. Print 2004.
- Results publication: PubMed 28432601Meacham K, Shepherd A, Mohapatra DP, Haroutounian S. Neuropathic Pain: Central vs. Peripheral Mechanisms. Curr Pain Headache Rep. 2017 Jun;21(6):28. doi: 10.1007/s11916-017-0629-5.
- Results publication: PubMed 25255012Rosero EB, Joshi GP. Preemptive, preventive, multimodal analgesia: what do they really mean? Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):85S-93S. doi: 10.1097/PRS.0000000000000671.
- Results publication: PubMed 22227789American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Results publication: PubMed 8346839Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Tapentadol 100 MG Oral Tablet and Pregabalin 150mg in people with Osteoarthritis, Knee, 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 1 inclusion and 2 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 25 Jun 2020. 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?
Efficacy and safety of pregabalin and tapentadol by measuring the mean difference in the mean VAS score. (time frame: Evaluated over 24hrs post unilateral total knee arthroplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604354, which also lists 17 linked publications.
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 25 Jun 2020.