Depot-opioids for Pre- and Postoperative Pain Relief Afte... | NCT02604446

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

NCT02604446

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

Nov 16, 2021Actual

Enrollment

134Actual

Phase

Phase 3

Conditions

Joint Diseases

Interventions

Tapentadol
Oxycodone
Placebo
usual pain treatment

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-000295-94	EudraCT Number

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Feb 2019Actual

Completion Date

Feb 2019Actual

First Submitted Date

Nov 11, 2015

First Submission Date that Met QC Criteria

Nov 12, 2015

First Posted Date

Nov 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2021

Last Update Posted Date

Nov 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tapentadol	Drug		Tapentadol	Palexia Depot
Oxycodone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pain at rest in the previous 24 hours	NRS-scores 1-10 scale	8 days
worst pain in the previous 24 hours	NRS-scores 1-10 scale	8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Petter Aadahl, md phd	St. Olavs Hospital	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32773594	Result	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.
35482392	Derived

ID	Term
D007592	Joint Diseases
D000377	Agnosia

ID	Term
D009140	Musculoskeletal Diseases
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

ID	Term
D000077432	Tapentadol
D010098	Oxycodone
D005947	Glucose

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic