Clinical trial NCT02604446: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Joint Diseases
Keywords: Arthroplasty, Replacement, Knee
Analgesics
Administration and dosage
Knee
Postoperational care
Pain management
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Area under curve (AUC) based on daily numeric rating score (NRS) scale 1-10 for pain by mobilization the first 8 postoperative days
timeFrame: 8 days
Secondary outcomes:
measure: Pain at rest in the previous 24 hours
timeFrame: 8 days
measure: worst pain in the previous 24 hours
timeFrame: 8 days
measure: quality of sleep in the previous night
timeFrame: 8 days
measure: nausea in the previous 24 hours
timeFrame: 8 days
measure: obstipation in the previous 24 hours
timeFrame: 8 days
measure: dizziness in the previous 24 hours
timeFrame: 8 days
measure: sedation in the previous 24 hours
timeFrame: 8 days
measure: headache
timeFrame: 8 days in the previous 24 hours
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Anestesiavdelingen, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Petter Aadahl, md phd
role: STUDY_DIRECTOR
References:
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.
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.