Tapentadol vs Tramadol in Total Knee Arthroplasty

Multimodal Analgesia in TKA. The Role of Tapentadol

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Total Knee Replacement; Post-operative Pain
• Intervention / Treatment: Drug: Tramadol; Drug: Tapentadol

Detailed Description

As the population ages and becomes more active, the demand for TKR surgery is expected to increase. However, the treatment of TKR pain remains a challenge.

Postoperative pain is associated with longer hospital stays, lower satisfaction, increased opioid consumption, and transition to chronic pain. In TKR, the risk of chronic pain can be as high as 20%.

A suggested method of anesthesia and pain relief is the use of spinal anesthesia along with multimodal analgesia that includes an adductor canal block.

In our hospital, the multimodal analgesia protocol consists of intraoperative sedation with dexmedetomidine, a low dose of ketamine, paracetamol, NSAIDs, and magnesium. Dexamethasone and droperidol are preferred as antiemetics as they can improve the analgesic outcome.

To minimize the use of opioids, the administration of tramadol used to be the standard of care. Tapentadol is an opioid that can be equally effective in the treatment of postoperative pain and reduces the incidence of chronic pain after TKR.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Metaxia Bareka, MD, PhD; Phone Number: +306947845083; Email: barekametaxia@hotmail.com
• Study Contact Backup: Name: Eleni Arnaoutoglou, MD, PhD; Phone Number: 00302413502952; Email: earnaout@gmail.com

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • Recruiting
      • University Hospital Of Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients for elective TKR
• ASA PS I - III

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tramadol; Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain.	Drug: Tramadol; Add tramadol, for effective pain management in a multimodal setting during TKR.
Active Comparator: Tapentadol; Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain.	Drug: Tapentadol; Add tapentadol, for effective pain management in a multimodal setting during TKR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	3 weeks after surgery
Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	6 weeks after surgery
Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	6 months after surgery
Neuropathic pain	PainDETECT (0-35)	6 months after surgery
Quality of life postoperatively	Patient Quality 15 (0-150)	6 months after surgery
Function	Oxford Knee Score (OKS) (0-48)	6 weeks after surgery
Outcome	Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100)	6 weeks after surgery
Arthritis impact	ARTHRITIS IMPACT MEASUREMENT SCALES 2 Short Form (AIMS2-SF) (5Likert scale	6 weeks after surgery
Patient Satisfaction	5-point Likert scale (0-5) [5 representing higher satisfaction]	5 days after surgery at Discharge
Depression	Patient Health Questionnaire 9 (PHQ9) (0-27) [The higher the score, more severe the depression]	5 days after surgery at Discharge
Health Status	5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) [The higher the score, the worse the health status]	6 weeks after surgery
Pain severity	Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (0-96) [The higher the score the higher the disability due to osteoarthritis]	6 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Study Chair: Eleni Arnaoutolglou, MD, PhD, Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly; Principal Investigator: Metaxia Bareka, MD, PhD, Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 3, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: total knee replacement; tramadol; post-operative pain; tapentadol
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Tramadol; Tapentadol
• Other Study ID Numbers: Tapentadol

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