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

February 5, 2023 updated by: Dr Kassiani Theodoraki, Aretaieion University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 17674
        • Recruiting
        • Onassis Cardiac Surgery Centre
      • Athens, Greece
        • Recruiting
        • Ygeia General Hospital of Athens
        • Contact:
          • Vassiliki Lavranou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: tapentadol 50 mg
tapentadol 50mg p.o 3 times daily for two days
Drug: Group tapentadol 50 mg
patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days
Other Names:
  • group A
ACTIVE_COMPARATOR: tapentadol 75 mg
tapentadol 75 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
Other Names:
  • group B
ACTIVE_COMPARATOR: tramadol 100 mg
tramadol 100 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
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
Time Frame: 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"
2 hours after analgesia administration
change from baseline in pain score during coughing
Time Frame: 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"
2 hours after analgesia administration
side effects
Time Frame: 2 hours after analgesia administration
side effects resulting from analgesic administration, yes or no
2 hours after analgesia administration
incidence of chronic pain 3 months after surgery
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: postoperatively, an average period of 10 days
duration of hospital stay after surgery in days
postoperatively, an average period of 10 days
satisfaction from postoperative analgesia
Time Frame: 72 hours postoperatively
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aretaieion University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

January 17, 2021

First Submitted That Met QC Criteria

January 17, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 5, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 668/24.02.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on Group tapentadol 50 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe