Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery

NCT ID: NCT04718116

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

tapentadol 50 mg

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

Group Type: ACTIVE_COMPARATOR

Group tapentadol 50 mg

Intervention Type: DRUG

patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days

tapentadol 75 mg

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

Group Type: ACTIVE_COMPARATOR

group tapentadol 75 mg

Intervention Type: DRUG

patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days

tramadol 100 mg

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

Group Type: ACTIVE_COMPARATOR

group tramadol 100 mg

Intervention Type: DRUG

patients in group C will receive tramadol 100 mg p.o 3 times daily for two days

Interventions

Group tapentadol 50 mg

patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days

Intervention Type: DRUG

group tapentadol 75 mg

patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days

Intervention Type: DRUG

group tramadol 100 mg

patients in group C will receive tramadol 100 mg p.o 3 times daily for two days

Intervention Type: DRUG

Other Intervention Names

group A; group B; group C

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aretaieion University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Kassiani Theodoraki

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kassiani Theodoraki, PhD, DESA

Role: PRINCIPAL_INVESTIGATOR

Aretaieion University Hospital

Locations

Onassis Cardiac Surgery Centre

Athens, , Greece

Site Status: RECRUITING

Ygeia General Hospital of Athens

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Kassiani Theodoraki, PhD, DESA

Role: CONTACT

ktheodoraki@hotmail.com

+306974634162

Facility Contacts

Theophani Antoniou, MD, PhD

Role: primary

antoniou_fani@yahoo.gr

Vassiliki Lavranou, MD

Role: backup

vasolav82@hotmail.gr

Vassiliki Lavranou, MD

Role: primary

References

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Reference Type: BACKGROUND

PMID: 24319854 (View on PubMed)

Roediger L, Larbuisson R, Lamy M. New approaches and old controversies to postoperative pain control following cardiac surgery. Eur J Anaesthesiol. 2006 Jul;23(7):539-50. doi: 10.1017/S0265021506000548.

Reference Type: BACKGROUND

PMID: 16677435 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19681771 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30333328 (View on PubMed)

Tzschentke TM, Christoph T, Kogel BY. The mu-opioid receptor agonist/noradrenaline reuptake inhibition (MOR-NRI) concept in analgesia: the case of tapentadol. CNS Drugs. 2014 Apr;28(4):319-29. doi: 10.1007/s40263-014-0151-9.

Reference Type: BACKGROUND

PMID: 24578192 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 27867511 (View on PubMed)

Raffa RB, Buschmann H, Christoph T, Eichenbaum G, Englberger W, Flores CM, Hertrampf T, Kogel B, Schiene K, Strassburger W, Terlinden R, Tzschentke TM. Mechanistic and functional differentiation of tapentadol and tramadol. Expert Opin Pharmacother. 2012 Jul;13(10):1437-49. doi: 10.1517/14656566.2012.696097. Epub 2012 Jun 15.

Reference Type: BACKGROUND

PMID: 22698264 (View on PubMed)

Lee YK, Ko JS, Rhim HY, Lee EJ, Karcher K, Li H, Shapiro D, Lee HS. Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea. Curr Med Res Opin. 2014 Dec;30(12):2561-70. doi: 10.1185/03007995.2014.954665. Epub 2014 Aug 27.

Reference Type: BACKGROUND

PMID: 25133962 (View on PubMed)

Other Identifiers

668/24.02.2020

Identifier Type: -

Identifier Source: org_study_id