Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo

NCT02604446 | Completed Phase 3

• 2 other identifiers: TPO-1502015-000295-94
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This study will provide knowledge about the use of long-acting opioids for pain relief after primary knee arthroplasty. The investigators will compare depot tapentadol, depot oxycodone and placebo for effect on pain relief and side effects. The three study groups reflect the three different postoperative pain regimens that have been used the last years at St. Olavs Hospital, so investigators know that no patient will receive an inadequate pain treatment. The purpose of the study is to find which of the three treatments that gives the best pain relief with the least amount of side effects. The results will be of use for postoperative pain treatment for knee arthroplasty, but also for other types of major surgery. Similar studies that are not sponsored by pharmaceutical industry have not been published yet.

Conditions

Joint Diseases

Keywords

Arthroplasty, Replacement, Knee; Analgesics; Administration and dosage; Knee; Postoperational care; Pain management

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC) based on daily numeric rating score (NRS) scale 1-10 for pain by mobilization the first 8 postoperative days

  NRS-scores

  8 days

Secondary Outcomes (8)

• Pain at rest in the previous 24 hours

  8 days

• worst pain in the previous 24 hours

  8 days

• quality of sleep in the previous night

  8 days

• nausea in the previous 24 hours

  8 days

• obstipation in the previous 24 hours

  8 days

Study Arms (3)

Tapentadol

EXPERIMENTAL

depot Tapentadol in addition to usual pain treatment

Drug: Tapentadol; Drug: usual pain treatment

Oxycodone

ACTIVE COMPARATOR

depot Oxycodone in addition to usual pain treatment

Drug: Oxycodone; Drug: usual pain treatment

Placebo

PLACEBO COMPARATOR

depot glucose placebo in addition to usual pain treatment.

Drug: Placebo; Drug: usual pain treatment

Interventions

Tapentadol DRUG

Also known as: Palexia Depot

Tapentadol

Oxycodone DRUG

Also known as: Oxycontin

Oxycodone

Placebo DRUG

Also known as: Glucose

Placebo

usual pain treatment DRUG

premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo

Oxycodone; Placebo; Tapentadol

Eligibility Criteria

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

You may qualify if:

• scheduled for knee arthroplasty at St. Olavs University Hospital
• consent in participation in the study

You may not qualify if:

• Contraindications for any of the study drugs
• Lactose intolerance
• Known hypersensitivity against any of the additives
• Chronic Obstructive Pulmonary Disease (COPD) grade 3 or 4
• Paralytic ileus
• Known alcohol or medical addiction/abuse
• History of asthma, urticaria or allergic reaction caused by acetyl salicylic acid or other NSAIDs
• Peptic ulcer
• Hemophilia
• Gastrointestinal bleeding
• Cerebrovascular bleeding
• Inflammatory bowel disease (ulcerous colitis, Crohn disease)
• Concomitant use of the following drugs: ACE-inhibitors, AT2-blockers, SSRI, Anti-psychotic drugs, MAO-inhibitors, Atazanavir and Nelfinavir (medicine used for HIV-infection)
• Known kidney failure (creatinin level above reference value)
• Known heart failure (NYHA III-IV)

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

Anestesiavdelingen, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

• 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 RESULT

• Rian T, Sand K, Skogvoll E, Klepstad P, Wik TS. A Web-Based Communication Tool for Postoperative Follow-up and Pain Assessment at Home After Primary Knee Arthroplasty: Feasibility and Usability Study. JMIR Form Res. 2022 Apr 28;6(4):e34543. doi: 10.2196/34543.

  PMID: 35482392 DERIVED

MeSH Terms

Conditions

Joint Diseases; Agnosia

Interventions

Tapentadol; Oxycodone; Glucose

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Petter Aadahl, md phd

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 13, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

NO (1)