MedDataX Logo

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

NCT ID: NCT02604446

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Joint Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tapentadol

depot Tapentadol in addition to usual pain treatment

Group Type EXPERIMENTAL

Tapentadol

Intervention Type DRUG

usual pain treatment

Intervention Type DRUG

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

Oxycodone

depot Oxycodone in addition to usual pain treatment

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

usual pain treatment

Intervention Type DRUG

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

Placebo

depot glucose placebo in addition to usual pain treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

usual pain treatment

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tapentadol

Intervention Type DRUG

Oxycodone

Intervention Type DRUG

Placebo

Intervention Type DRUG

usual pain treatment

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Palexia Depot Oxycontin Glucose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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)
* Pregnancy
* Women in fertile age with risk of pregnancy
* Nursing women
* operated under general anesthesia without use of spinal anesthesia
* using opioids on a regular basis except users of codeine or tramadol, or known former abuse of opioids
* Cognitive failure or other factors which make follow up impossible (for example language difficulties)
* No cell phone or internet connection at home (making follow up difficult)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Petter Aadahl, md phd

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anestesiavdelingen, St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 32773594 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35482392 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-000295-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TPO-150

Identifier Type: -

Identifier Source: org_study_id