search
Back to results

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

Primary Purpose

Joint Diseases

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Tapentadol
Oxycodone
Placebo
usual pain treatment
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Diseases focused on measuring Arthroplasty, Replacement, Knee, Analgesics, Administration and dosage, Knee, Postoperational care, Pain management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Anestesiavdelingen, St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Tapentadol

Oxycodone

Placebo

Arm Description

depot Tapentadol in addition to usual pain treatment

depot Oxycodone in addition to usual pain treatment

depot glucose placebo in addition to usual pain treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain at rest in the previous 24 hours
NRS-scores 1-10 scale
worst pain in the previous 24 hours
NRS-scores 1-10 scale
quality of sleep in the previous night
NRS-scores 1-10 scale
nausea in the previous 24 hours
NRS-scores 1-10 scale
obstipation in the previous 24 hours
NRS-scores 1-10 scale
dizziness in the previous 24 hours
NRS-scores 1-10 scale
sedation in the previous 24 hours
NRS-scores 1-10 scale
headache
NRS-scores 1-10 scale

Full Information

First Posted
November 11, 2015
Last Updated
November 10, 2021
Sponsor
St. Olavs Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02604446
Brief Title
Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo
Official Title
Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty. A Double Blinded Randomized Controlled Study. Tapentadol vs Oxycodone vs Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Diseases
Keywords
Arthroplasty, Replacement, Knee, Analgesics, Administration and dosage, Knee, Postoperational care, Pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tapentadol
Arm Type
Experimental
Arm Description
depot Tapentadol in addition to usual pain treatment
Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
depot Oxycodone in addition to usual pain treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
depot glucose placebo in addition to usual pain treatment.
Intervention Type
Drug
Intervention Name(s)
Tapentadol
Other Intervention Name(s)
Palexia Depot
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Oxycontin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Glucose
Intervention Type
Drug
Intervention Name(s)
usual pain treatment
Intervention Description
premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo
Primary Outcome Measure Information:
Title
Area under curve (AUC) based on daily numeric rating score (NRS) scale 1-10 for pain by mobilization the first 8 postoperative days
Description
NRS-scores
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Pain at rest in the previous 24 hours
Description
NRS-scores 1-10 scale
Time Frame
8 days
Title
worst pain in the previous 24 hours
Description
NRS-scores 1-10 scale
Time Frame
8 days
Title
quality of sleep in the previous night
Description
NRS-scores 1-10 scale
Time Frame
8 days
Title
nausea in the previous 24 hours
Description
NRS-scores 1-10 scale
Time Frame
8 days
Title
obstipation in the previous 24 hours
Description
NRS-scores 1-10 scale
Time Frame
8 days
Title
dizziness in the previous 24 hours
Description
NRS-scores 1-10 scale
Time Frame
8 days
Title
sedation in the previous 24 hours
Description
NRS-scores 1-10 scale
Time Frame
8 days
Title
headache
Description
NRS-scores 1-10 scale
Time Frame
8 days in the previous 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter Aadahl, md phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Anestesiavdelingen, St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32773594
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.
Results Reference
result
PubMed Identifier
35482392
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs