Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Postoperative Pain; Surgery; Pain, Acute; Pain, Postoperative; Pain, Chronic; Pain, Neuropathic; Analgesia; Pain, Procedural
• Interventions: Drug: group tramadol 100 mg; Drug: group tapentadol 75 mg; Drug: Group tapentadol 50 mg

• Registration Number: NCT04718116
• Lead Sponsor: Aretaieion University Hospital

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.

Study Timeline

• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-17
• Study First Posted: 2021-01-22
• Study Start: 2022-11-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tramadol 100 mg	group tramadol 100 mg	tramadol 100 mg p.o 3 times daily for two days
tapentadol 75 mg	group tapentadol 75 mg	tapentadol 75 mg p.o 3 times daily for two days
tapentadol 50 mg	Group tapentadol 50 mg	tapentadol 50mg p.o 3 times daily for two days

Primary Outcome Measures

Name	Time	Method
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 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"
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
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 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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Onassis Cardiac Surgery Centre; 🇬🇷 Athens, Greece

Ygeia General Hospital of Athens; 🇬🇷 Athens, Greece