Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery

Study Overview
=================
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.

Official Title
-----------------
Management of Postsurgical Pain After Cardiac Operations: Comparison of Tapentadol and Tramadol Analgesia

Conditions
-----------------
Surgery, Pain, Acute, Postoperative Pain, Pain, Postoperative, Pain, Chronic, Pain, Procedural, Pain, Neuropathic, Analgesia

Intervention / Treatment
-----------------
* Drug: Group tapentadol 50 mg
* Drug: group tapentadol 75 mg
* Drug: group tramadol 100 mg


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tapentadol 50 mg<br>tapentadol 50mg p.o 3 times daily for two days | Drug: Group tapentadol 50 mg<br>* patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days<br>* Other names: group A;|
| Active Comparator: tapentadol 75 mg<br>tapentadol 75 mg p.o 3 times daily for two days | Drug: group tapentadol 75 mg<br>* patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days<br>* Other names: group B;|
| Active Comparator: tramadol 100 mg<br>tramadol 100 mg p.o 3 times daily for two days | Drug: group tramadol 100 mg<br>* patients in group C will receive tramadol 100 mg p.o 3 times daily for two days<br>* Other names: group C;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | occurrence of neuropathic pain 6 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 72 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tapentadol, tramadol