Clinical trial NCT04718116: Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery
Official title: Management of Postsurgical Pain After Cardiac Operations: Comparison of Tapentadol and Tramadol Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Surgery
Pain, Postoperative
Pain, Acute
Pain, Chronic
Pain, Procedural
Pain, Neuropathic
Analgesia
Keywords: tapentadol
tramadol
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* age \<75 years old
* patients discharged from Intensive Care Unit (ICU) in less than 30 hours
* elective cardiac surgery

Exclusion Criteria:

* 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
* age\>75 years old
* communication or language barriers
* Lack of informed consent

Primary outcomes:
measure: change from baseline in pain score at rest
timeFrame: 2 hours after analgesia administration
measure: change from baseline in pain score during coughing
timeFrame: 2 hours after analgesia administration
measure: side effects
timeFrame: 2 hours after analgesia administration
measure: incidence of chronic pain 3 months after surgery
timeFrame: 3 months after surgery
measure: incidence of chronic pain 6 months after surgery
timeFrame: 6 months after surgery
measure: incidence of neuropathic pain 3 months after surgery
timeFrame: 3 months after surgery
measure: incidence of neuropathic pain 6 months after surgery
timeFrame: 6 months after surgery
Secondary outcomes:
measure: hospitalization time
timeFrame: postoperatively, an average period of 10 days
measure: satisfaction from postoperative analgesia
timeFrame: 72 hours postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Centre
city: Athens
country: Greece
facility: Ygeia General Hospital of Athens
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.