Tapentadol vs Tramadol in Total Knee Arthroplasty

Chronic Pain Clinical Trial

Official title:

Multimodal Analgesia in TKA. The Role of Tapentadol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269770
• Other study ID #: Tapentadol
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: University of Thessaly
• Contact: Eleni Arnaoutoglou, MD, PhD
• Phone: 00302413502952
• Email: earnaout[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative
• Post-operative Pain
• Total Knee Replacement

Intervention

Drug:
• Tapentadol
Add tapentadol, for effective pain management in a multimodal setting during TKR.
• Tramadol
Add tramadol, for effective pain management in a multimodal setting during TKR.

Locations

Country	Name	City	State
Greece	University Hospital Of Larissa	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	6 hours after surgery
Primary	Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	12 hours after surgery
Primary	Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	1st postoperative day
Primary	Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	2nd postoperative day
Primary	Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	3rd postoperative day
Secondary	Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	3 weeks after surgery
Secondary	Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	6 weeks after surgery
Secondary	Post-operative pain	Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)	6 months after surgery
Secondary	Neuropathic pain	PainDETECT (0-35)	6 months after surgery
Secondary	Quality of life postoperatively	Patient Quality 15 (0-150)	6 months after surgery
Secondary	Patient Satisfaction	5-point Likert scale (0-5) [5 representing higher satisfaction]	5 days after surgery at Discharge
Secondary	Depression	Patient Health Questionnaire 9 (PHQ9) (0-27) [The higher the score, more severe the depression]	5 days after surgery at Discharge
Secondary	Function	Oxford Knee Score (OKS) (0-48)	6 weeks after surgery
Secondary	Outcome	Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100)	6 weeks after surgery
Secondary	Arthritis impact	ARTHRITIS IMPACT MEASUREMENT SCALES 2 Short Form (AIMS2-SF) (5Likert scale	6 weeks after surgery
Secondary	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
Secondary	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