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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tapentadol 50 mg | Active Comparator | tapentadol 50mg p.o 3 times daily for two days |
|
| tapentadol 75 mg | Active Comparator | tapentadol 75 mg p.o 3 times daily for two days |
|
| tramadol 100 mg | Active Comparator | tramadol 100 mg p.o 3 times daily for two days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group tapentadol 50 mg | Drug | patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 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" | 2 hours after analgesia administration |
| side effects | side effects resulting from analgesic administration, yes or no | 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 | 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 | 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 | 3 months after surgery |
| incidence of neuropathic pain 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| hospitalization time | duration of hospital stay after surgery in days | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kassiani Theodoraki, PhD, DESA | Contact | +306974634162 | ktheodoraki@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kassiani Theodoraki, PhD, DESA | Aretaieion University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onassis Cardiac Surgery Centre | Recruiting | Athens | 17674 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24319854 | Background | 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. | |
| 16677435 | Background | Roediger 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D000073818 | Pain, Procedural |
| D009437 | Neuralgia |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| group tapentadol 75 mg | Drug | patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days |
|
|
| group tramadol 100 mg | Drug | patients in group C will receive tramadol 100 mg p.o 3 times daily for two days |
|
|
occurrence of neuropathic pain 6 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire |
| 6 months after surgery |
| 72 hours postoperatively |
| Ygeia General Hospital of Athens | Recruiting | Athens | Greece |
|
| 16733157 | Background | Taillefer 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. |
| 19681771 | Background | Gjeilo 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. |
| 30333328 | Background | Nachiyunde 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. |
| 24578192 | Background | Tzschentke 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. |
| 27867511 | Background | Langford 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. |
| 22698264 | Background | Raffa 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. |
| 25133962 | Background | Lee 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |