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

Sponsor

St. Olavs Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02604446

Collaborator

(none)

134

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Joint Diseases	Drug: Tapentadol Drug: Oxycodone Drug: Placebo Drug: usual pain treatment	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tapentadol depot Tapentadol in addition to usual pain treatment	Drug: Tapentadol Other Names: Palexia Depot Drug: usual pain treatment premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo
Active Comparator: Oxycodone depot Oxycodone in addition to usual pain treatment	Drug: Oxycodone Other Names: Oxycontin Drug: usual pain treatment premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo
Placebo Comparator: Placebo depot glucose placebo in addition to usual pain treatment.	Drug: Placebo Other Names: Glucose Drug: usual pain treatment premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo

Arm

Intervention/Treatment

Experimental: Tapentadol

depot Tapentadol in addition to usual pain treatment

Drug: Tapentadol

Other Names:

Palexia Depot

Drug: usual pain treatment

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

Active Comparator: Oxycodone

depot Oxycodone in addition to usual pain treatment

Drug: Oxycodone

Other Names:

Oxycontin

Drug: usual pain treatment

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

Placebo Comparator: Placebo

depot glucose placebo in addition to usual pain treatment.

Drug: Placebo

Other Names:

Glucose

Drug: usual pain treatment

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

Outcome Measures

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 [8 days]
NRS-scores

Secondary Outcome Measures

Pain at rest in the previous 24 hours [8 days]
NRS-scores 1-10 scale
worst pain in the previous 24 hours [8 days]
NRS-scores 1-10 scale
quality of sleep in the previous night [8 days]
NRS-scores 1-10 scale
nausea in the previous 24 hours [8 days]
NRS-scores 1-10 scale
obstipation in the previous 24 hours [8 days]
NRS-scores 1-10 scale
dizziness in the previous 24 hours [8 days]
NRS-scores 1-10 scale
sedation in the previous 24 hours [8 days]
NRS-scores 1-10 scale
headache [8 days in the previous 24 hours]
NRS-scores 1-10 scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)