Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery

Last updated: February 5, 2023
Sponsor: Aretaieion University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Pain

Chronic Pain

Pain

Treatment

N/A

Clinical Study ID

NCT04718116
668/24.02.2020
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 orantiepileptics
  • age>75 years old
  • communication or language barriers
  • Lack of informed consent

Study Design

Total Participants: 90
Study Start date:
November 01, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Onassis Cardiac Surgery Centre

    Athens, 17674
    Greece

    Active - Recruiting

  • Ygeia General Hospital of Athens

    Athens,
    Greece

    Active - Recruiting

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