NCT04718116

Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Aretaieion University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain
• Surgery
• Pain, Postoperative
• Pain, Acute
• Pain, Chronic
• Pain, Procedural
• Pain, Neuropathic
• Analgesia

Interventions

Type	Name	Description
DRUG	Group tapentadol 50 mg	patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days
DRUG	group tapentadol 75 mg	patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days
DRUG	group tramadol 100 mg	patients in group C will receive tramadol 100 mg p.o 3 times daily for two days

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-01-22
• Last updated: 2023-02-08

Locations

2 sites across 1 country: Greece