Clinical trial NCT06269770: Tapentadol vs Tramadol in Total Knee Arthroplasty
Official title: Multimodal Analgesia in TKA. The Role of Tapentadol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Total Knee Replacement
Post-operative Pain
Chronic Pain
Keywords: total knee replacement
post-operative pain
tramadol
tapentadol
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative pain
timeFrame: 6 hours after surgery
measure: Post-operative pain
timeFrame: 12 hours after surgery
measure: Post-operative pain
timeFrame: 1st postoperative day
measure: Post-operative pain
timeFrame: 2nd postoperative day
measure: Post-operative pain
timeFrame: 3rd postoperative day
Secondary outcomes:
measure: Post-operative pain
timeFrame: 3 weeks after surgery
measure: Post-operative pain
timeFrame: 6 weeks after surgery
measure: Post-operative pain
timeFrame: 6 months after surgery
measure: Neuropathic pain
timeFrame: 6 months after surgery
measure: Quality of life postoperatively
timeFrame: 6 months after surgery
measure: Patient Satisfaction
timeFrame: 5 days after surgery at Discharge
measure: Depression
timeFrame: 5 days after surgery at Discharge
measure: Function
timeFrame: 6 weeks after surgery
measure: Outcome
timeFrame: 6 weeks after surgery
measure: Arthritis impact
timeFrame: 6 weeks after surgery
measure: Health Status
timeFrame: 6 weeks after surgery
measure: Pain severity
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital Of Larissa
state: Thessaly
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
name: Eleni Arnaoutolglou, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
name: Metaxia Bareka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.