Postoperative Painvasso-annieNCT04718116
Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery
A study testing Group tapentadol 50 mg, group tapentadol 75 mg and group tramadol 100 mg in people with Postoperative Pain and Surgery, run by Aretaieion University Hospital at 2 sites in Greece.
Trial summary
The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain) in cardiac surgery patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Surgery, Pain, Postoperative
- What is being tested?
- Group tapentadol 50 mg, group tapentadol 75 mg and group tramadol 100 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Nov 2022to 31 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age <75 years old
- patients discharged from Intensive Care Unit (ICU) in less than 30 hours
- elective cardiac surgery
Who cannot join
- hepatic failure (increased transaminase levels
- renal failure (creatinine> 2 mg/dL)
- ileus
- emergency surgery (hemorrhage, tamponade, aortic dissection)
- readmission in ICU
- treatment with monoaminoxidase inhibitors, selective serotonine reuptake inhibitors or antiepileptics
Show all 9Show fewer
- age>75 years old
- communication or language barriers
- Lack of informed consent
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
Onassis Cardiac Surgery Centre
Athens, 17674
Theophani Antoniou, MD, PhD, antoniou_fani@yahoo.gr
Vassiliki Lavranou, MD, vasolav82@hotmail.gr
- Recruiting
Ygeia General Hospital of Athens
Athens
Vassiliki Lavranou, MD
About this study
Official title: Management of Postsurgical Pain After Cardiac Operations: Comparison of Tapentadol and Tramadol Analgesia
The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain) in cardiac surgery patients
Read the detailed description
Management of post-surgical pain is a daily challenge for every anaesthetist. Undertreated post-surgical pain can result in cardiovascular, pulmonary and gastrointestinal complications, as well as chronic pain and negative psychological effects. A negative impact may be seen on immune function, coagulation and wound healing. Opioids have been the cornerstone in the treatment of pain after cardiac surgery. However, opioids have a number of adverse effects such as respiratory depression, gastrointestinal alterations, dizziness, delirium, addiction.
Tapentadol is a new synthetic opioid with dual mechanism of action. It acts as a mu-receptor agonist, as well as norepinephrine reuptake inhibitor. It is used to treat moderate to severe pain and is associated with fewer adverse effects compared to other opioids.
The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain).
Patients undergoing cardiac surgery and being discharged from ICU to ward within 30 hours of surgery, will be divided into 3 groups. Group A will receive tapentadol 50mg p.o 3 times daily for two days, group B will receive tapentadol 75 mg p.o 3 times daily for two days and group C will receive tramadol 100 mg p.o 3 times daily for two days. Pain level will be assessed with Numeric Rating Scale (NRS), before drug administration and two hours after drug administration. Overall patient satisfaction will be assessed with Likert scale. Brief Pain Inventory( short form) and DN4 questionnaire will be used to detect chronic pain and neuropathic pain respectively, 3 and 6 months after surgery.
- Conditions
- Postoperative Pain, Surgery, Pain, Postoperative, Pain, Acute, Pain, Chronic, Pain, Procedural
- Being tested
- Group tapentadol 50 mg, group tapentadol 75 mg, group tramadol 100 mg
- Keywords
- tapentadol, tramadol
- Medical subject headings
- Pain, Postoperative, Acute Pain, Chronic Pain, Pain, Procedural, Neuralgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group tapentadol 50 mgDrug
Also called group A
patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days
group tapentadol 75 mgDrug
Also called group B
patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days
group tramadol 100 mgDrug
Also called group C
patients in group C will receive tramadol 100 mg p.o 3 times daily for two days
| Study group | Role | What they receive |
|---|---|---|
| tapentadol 50 mg | Active comparator | tapentadol 50mg p.o 3 times daily for two days Receives: Drug: Group tapentadol 50 mg |
| tapentadol 75 mg | Active comparator | tapentadol 75 mg p.o 3 times daily for two days Receives: Drug: group tapentadol 75 mg |
| tramadol 100 mg | Active comparator | tramadol 100 mg p.o 3 times daily for two days Receives: Drug: group tramadol 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in pain score at rest
pain score will be assessed by the use of Numeric Rating Scale (NRS) 2 hours after analgesia administration, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: 2 hours after analgesia administration
change from baseline in pain score during coughing
pain score will be assessed by the use of Numeric Rating Scale (NRS) 2 hours after analgesia administration, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: 2 hours after analgesia administration
side effects
side effects resulting from analgesic administration, yes or no
Measured: 2 hours after analgesia administration
incidence of chronic pain 3 months after surgery
occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Brief Pain Inventory Questionnaire
Measured: 3 months after surgery
incidence of chronic pain 6 months after surgery
occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Brief Pain Inventory Questionnaire
Measured: 6 months after surgery
incidence of neuropathic pain 3 months after surgery
occurrence of neuropathic pain 3 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire
Measured: 3 months after surgery
incidence of neuropathic pain 6 months after surgery
occurrence of neuropathic pain 6 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire
Measured: 6 months after surgery
Secondary outcomes (2)
hospitalization time
duration of hospital stay after surgery in days
Measured: postoperatively, an average period of 10 days
satisfaction from postoperative analgesia
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DESA, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718116
- Sponsor's protocol ID
- 668/24.02.2020
- Acronym
- vasso-annie
- Status last verified
- Feb 2023
- First submitted
- 17 Jan 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013 Jul;96(7):824-8.
PubMed 24319854Roediger L, Larbuisson R, Lamy M. New approaches and old controversies to postoperative pain control following cardiac surgery. Eur J Anaesthesiol. 2006 Jul;23(7):539-50. doi: 10.1017/S0265021506000548.
PubMed 16677435Taillefer MC, Carrier M, Belisle S, Levesque S, Lanctot H, Boisvert AM, Choiniere M. Prevalence, characteristics, and predictors of chronic nonanginal postoperative pain after a cardiac operation: a cross-sectional study. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1274-80. doi: 10.1016/j.jtcvs.2006.02.001.
PubMed 16733157Gjeilo KH, Klepstad P, Wahba A, Lydersen S, Stenseth R. Chronic pain after cardiac surgery: a prospective study. Acta Anaesthesiol Scand. 2010 Jan;54(1):70-8. doi: 10.1111/j.1399-6576.2009.02097.x. Epub 2009 Aug 13.
PubMed 19681771Nachiyunde B, Lam L. The efficacy of different modes of analgesia in postoperative pain management and early mobilization in postoperative cardiac surgical patients: A systematic review. Ann Card Anaesth. 2018 Oct-Dec;21(4):363-370. doi: 10.4103/aca.ACA_186_17.
PubMed 30333328Tzschentke TM, Christoph T, Kogel BY. The mu-opioid receptor agonist/noradrenaline reuptake inhibition (MOR-NRI) concept in analgesia: the case of tapentadol. CNS Drugs. 2014 Apr;28(4):319-29. doi: 10.1007/s40263-014-0151-9.
PubMed 24578192Langford RM, Knaggs R, Farquhar-Smith P, Dickenson AH. Is tapentadol different from classical opioids? A review of the evidence. Br J Pain. 2016 Nov;10(4):217-221. doi: 10.1177/2049463716657363. Epub 2016 Jul 25.
PubMed 27867511Raffa RB, Buschmann H, Christoph T, Eichenbaum G, Englberger W, Flores CM, Hertrampf T, Kogel B, Schiene K, Strassburger W, Terlinden R, Tzschentke TM. Mechanistic and functional differentiation of tapentadol and tramadol. Expert Opin Pharmacother. 2012 Jul;13(10):1437-49. doi: 10.1517/14656566.2012.696097. Epub 2012 Jun 15.
PubMed 22698264Lee YK, Ko JS, Rhim HY, Lee EJ, Karcher K, Li H, Shapiro D, Lee HS. Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea. Curr Med Res Opin. 2014 Dec;30(12):2561-70. doi: 10.1185/03007995.2014.954665. Epub 2014 Aug 27.
PubMed 25133962
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Postsurgical Pain After Cardiac Operations: Comparison of Tapentadol and Tramadol Analgesia
- ClinicalTrials.gov ID
- NCT04718116
- Acronym / sponsor ID
- vasso-annie / 668/24.02.2020
- Conditions
- Postoperative Pain, Surgery, Pain, Postoperative, Pain, Acute, Pain, Chronic, Pain, Procedural
- Keywords
- tapentadol, tramadol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Jan 2021 (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 this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain) in cardiac surgery patients
Detailed description
Management of post-surgical pain is a daily challenge for every anaesthetist. Undertreated post-surgical pain can result in cardiovascular, pulmonary and gastrointestinal complications, as well as chronic pain and negative psychological effects. A negative impact may be seen on immune function, coagulation and wound healing. Opioids have been the cornerstone in the treatment of pain after cardiac surgery. However, opioids have a number of adverse effects such as respiratory depression, gastrointestinal alterations, dizziness, delirium, addiction.
Tapentadol is a new synthetic opioid with dual mechanism of action. It acts as a mu-receptor agonist, as well as norepinephrine reuptake inhibitor. It is used to treat moderate to severe pain and is associated with fewer adverse effects compared to other opioids.
The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain).
Patients undergoing cardiac surgery and being discharged from ICU to ward within 30 hours of surgery, will be divided into 3 groups. Group A will receive tapentadol 50mg p.o 3 times daily for two days, group B will receive tapentadol 75 mg p.o 3 times daily for two days and group C will receive tramadol 100 mg p.o 3 times daily for two days. Pain level will be assessed with Numeric Rating Scale (NRS), before drug administration and two hours after drug administration. Overall patient satisfaction will be assessed with Likert scale. Brief Pain Inventory( short form) and DN4 questionnaire will be used to detect chronic pain and neuropathic pain respectively, 3 and 6 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tapentadol 50 mg | Active comparator | Drug: Group tapentadol 50 mgtapentadol 50mg p.o 3 times daily for two days |
| tapentadol 75 mg | Active comparator | Drug: group tapentadol 75 mgtapentadol 75 mg p.o 3 times daily for two days |
| tramadol 100 mg | Active comparator | Drug: group tramadol 100 mgtramadol 100 mg p.o 3 times daily for two days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age <75 years old
- patients discharged from Intensive Care Unit (ICU) in less than 30 hours
- elective cardiac surgery
Key exclusion criteria (9 listed)
- hepatic failure (increased transaminase levels
- renal failure (creatinine> 2 mg/dL)
- ileus
- emergency surgery (hemorrhage, tamponade, aortic dissection)
- readmission in ICU
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 |
|---|---|---|
| Group tapentadol 50 mgAlso: group Apatients in group A will receive tapentadol 50 mg p.o 3 times daily for two days | Drug | tapentadol 50 mg |
| group tapentadol 75 mgAlso: group Bpatients in group B will receive tapentadol 75 mg p.o 3 times daily for two days | Drug | tapentadol 75 mg |
| group tramadol 100 mgAlso: group Cpatients in group C will receive tramadol 100 mg p.o 3 times daily for two days | Drug | tramadol 100 mg |
Primary outcome
change from baseline in pain score at rest
Time frame: 2 hours after analgesia administration
pain score will be assessed by the use of Numeric Rating Scale (NRS) 2 hours after analgesia administration, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
change from baseline in pain score during coughing
Time frame: 2 hours after analgesia administration
pain score will be assessed by the use of Numeric Rating Scale (NRS) 2 hours after analgesia administration, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
side effects
Time frame: 2 hours after analgesia administration
side effects resulting from analgesic administration, yes or no
incidence of chronic pain 3 months after surgery
Time frame: 3 months after surgery
occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Brief Pain Inventory Questionnaire
incidence of chronic pain 6 months after surgery
Time frame: 6 months after surgery
occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Brief Pain Inventory Questionnaire
incidence of neuropathic pain 3 months after surgery
Time frame: 3 months after surgery
occurrence of neuropathic pain 3 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire
incidence of neuropathic pain 6 months after surgery
Time frame: 6 months after surgery
occurrence of neuropathic pain 6 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire
2 secondary outcomes
hospitalization time
Time frame: postoperatively, an average period of 10 days
satisfaction from postoperative analgesia
Time frame: 72 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 24319854Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013 Jul;96(7):824-8.
- Background: PubMed 16677435Roediger L, Larbuisson R, Lamy M. New approaches and old controversies to postoperative pain control following cardiac surgery. Eur J Anaesthesiol. 2006 Jul;23(7):539-50. doi: 10.1017/S0265021506000548.
- Background: PubMed 16733157Taillefer MC, Carrier M, Belisle S, Levesque S, Lanctot H, Boisvert AM, Choiniere M. Prevalence, characteristics, and predictors of chronic nonanginal postoperative pain after a cardiac operation: a cross-sectional study. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1274-80. doi: 10.1016/j.jtcvs.2006.02.001.
- Background: PubMed 19681771Gjeilo KH, Klepstad P, Wahba A, Lydersen S, Stenseth R. Chronic pain after cardiac surgery: a prospective study. Acta Anaesthesiol Scand. 2010 Jan;54(1):70-8. doi: 10.1111/j.1399-6576.2009.02097.x. Epub 2009 Aug 13.
- Background: PubMed 30333328Nachiyunde B, Lam L. The efficacy of different modes of analgesia in postoperative pain management and early mobilization in postoperative cardiac surgical patients: A systematic review. Ann Card Anaesth. 2018 Oct-Dec;21(4):363-370. doi: 10.4103/aca.ACA_186_17.
- Background: PubMed 24578192Tzschentke TM, Christoph T, Kogel BY. The mu-opioid receptor agonist/noradrenaline reuptake inhibition (MOR-NRI) concept in analgesia: the case of tapentadol. CNS Drugs. 2014 Apr;28(4):319-29. doi: 10.1007/s40263-014-0151-9.
- Background: PubMed 27867511Langford RM, Knaggs R, Farquhar-Smith P, Dickenson AH. Is tapentadol different from classical opioids? A review of the evidence. Br J Pain. 2016 Nov;10(4):217-221. doi: 10.1177/2049463716657363. Epub 2016 Jul 25.
- Background: PubMed 22698264Raffa RB, Buschmann H, Christoph T, Eichenbaum G, Englberger W, Flores CM, Hertrampf T, Kogel B, Schiene K, Strassburger W, Terlinden R, Tzschentke TM. Mechanistic and functional differentiation of tapentadol and tramadol. Expert Opin Pharmacother. 2012 Jul;13(10):1437-49. doi: 10.1517/14656566.2012.696097. Epub 2012 Jun 15.
- Background: PubMed 25133962Lee YK, Ko JS, Rhim HY, Lee EJ, Karcher K, Li H, Shapiro D, Lee HS. Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea. Curr Med Res Opin. 2014 Dec;30(12):2561-70. doi: 10.1185/03007995.2014.954665. Epub 2014 Aug 27.
- 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.
Kassiani Theodoraki, PhD, DESA principal investigator
Aretaieion University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group tapentadol 50 mg, group tapentadol 75 mg and group tramadol 100 mg in people with Postoperative Pain and Surgery, run by Aretaieion University Hospital at 2 sites in Greece.
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 9 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kassiani Theodoraki, PhD, DESA (+306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in pain score at rest (time frame: 2 hours after analgesia administration). The study lists 7 primary outcomes in all. 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 NCT04718116, which also lists 9 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 8 Feb 2023.