Analgesia, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Pain, Postoperative, Pain, Procedural, Postoperative Pain, Surgery
Conditions
Keywords
tapentadol, tramadol
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.
Interventions
DRUGGroup tapentadol 50 mg
patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days
DRUGgroup tapentadol 75 mg
patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days
DRUGgroup tramadol 100 mg
patients in group C will receive tramadol 100 mg p.o 3 times daily for two days
Sponsors
Aretaieion University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of neuropathic pain 6 months after surgery | 6 months after surgery | occurrence of neuropathic pain 6 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire |
| incidence of chronic pain 6 months after surgery | 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 | 3 months after surgery | occurrence of neuropathic pain 3 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire |
| change from baseline in pain score at rest | 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 | 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 | 2 hours after analgesia administration | side effects resulting from analgesic administration, yes or no |
| incidence of chronic pain 3 months after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| satisfaction from postoperative analgesia | 72 hours postoperatively | satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction |
| hospitalization time | postoperatively, an average period of 10 days | duration of hospital stay after surgery in days |
Countries
Greece
Contacts
Primary ContactKassiani Theodoraki, PhD, DESA
Outcome results
None listed