Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery (vasso-annie)

Aretaieion University Hospital

Status: Enrolling

Conditions: Postoperative Pain; Surgery; Pain, Acute; Pain, Postoperative; Pain, Chronic; Pain, Neuropathic; Analgesia; Pain, Procedural

Treatments: Drug: Group tapentadol 50 mg; Drug: group tramadol 100 mg; Drug: group tapentadol 75 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04718116

668/24.02.2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

tapentadol 50 mg

Active Comparator group

Description:

tapentadol 50mg p.o 3 times daily for two days

Treatment:

Drug: Group tapentadol 50 mg

tapentadol 75 mg

Active Comparator group

Description:

tapentadol 75 mg p.o 3 times daily for two days

Treatment:

Drug: group tapentadol 75 mg

tramadol 100 mg

Active Comparator group

Description:

tramadol 100 mg p.o 3 times daily for two days

Treatment:

Drug: group tramadol 100 mg