Tapentadol vs Tramadol in Total Knee Arthroplasty

NCT06269770 | Recruiting Phase 4

• 1 other identifier: Tapentadol
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).

Conditions

Total Knee Replacement; Post-operative Pain; Chronic Pain

Keywords

total knee replacement; post-operative pain; tramadol; tapentadol

Outcome Measures

Primary Outcomes (5)

• Post-operative pain

  Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

  6 hours after surgery

• Post-operative pain

  Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

  12 hours after surgery

• Post-operative pain

  Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

  1st postoperative day

• Post-operative pain

  Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

  2nd postoperative day

• Post-operative pain

  Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

  3rd postoperative day

Secondary Outcomes (12)

• Post-operative pain

  3 weeks after surgery

• Post-operative pain

  6 weeks after surgery

• Post-operative pain

  6 months after surgery

• Neuropathic pain

  6 months after surgery

• Quality of life postoperatively

  6 months after surgery

Study Arms (2)

Tramadol

ACTIVE COMPARATOR

Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain.

Drug: Tramadol

Tapentadol

ACTIVE COMPARATOR

Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain.

Drug: Tapentadol

Interventions

Tapentadol DRUG

Add tapentadol, for effective pain management in a multimodal setting during TKR.

Tapentadol

Tramadol DRUG

Add tramadol, for effective pain management in a multimodal setting during TKR.

Tramadol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients for elective TKR
• ASA PS I - III

You may not qualify if:

• Patient refusal
• Cognitive disfunction
• Severe psychiatric disease
• Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors
• Not speaking Greek
• Known allergy to the study drugs
• Contraindications for any of the study drugs
• Chronic renal failure (GFR \< 50 ml/h)
• Liver failure
• Known regular use or misuse of opioids
• Pregnant women
• Patients undergoing general anesthesia

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University Hospital Of Larissa

Larissa, Thessaly, 41110, Greece

RECRUITING

Related Publications (3)

• Baratta JL, Gandhi K, Viscusi ER. Perioperative pain management for total knee arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):22-36. doi: 10.3113/jsoa.2014.0022.

  PMID: 24641894 BACKGROUND

• Roulet L, Rollason V, Desmeules J, Piguet V. Tapentadol Versus Tramadol: A Narrative and Comparative Review of Their Pharmacological, Efficacy and Safety Profiles in Adult Patients. Drugs. 2021 Jul;81(11):1257-1272. doi: 10.1007/s40265-021-01515-z. Epub 2021 Jul 1.

  PMID: 34196947 BACKGROUND

• Rian T, Skogvoll E, Hofstad J, Hovik L, Winther SB, Husby VS, Klaksvik J, Egeberg T, Sand K, Klepstad P, Wik TS. Tapentadol vs oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial. Pain. 2021 Feb 1;162(2):396-404. doi: 10.1097/j.pain.0000000000002026.

  PMID: 32773594 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Tapentadol; Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Eleni Arnaoutolglou, MD, PhD

  Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly

  STUDY CHAIR

• Metaxia Bareka, MD, PhD

  Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni Arnaoutoglou, MD, PhD

CONTACT

00302413502952; earnaout@gmail.com

Metaxia Bareka, MD, PhD

CONTACT

+306947845083; barekametaxia@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Anesthesiology

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 21, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)