Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423716
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-16
Brief Title:
Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty RELIFE
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Effect of Perioperative Duloxetine Administration on Opioid Consumption Following Total Knee Arthroplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELIFE
Brief Summary:
Knee replacement surgery for osteoarthritis is a commonly performed procedure in Canada with 75000 of these surgeries performed each year Success rate for knee replacement surgery is high but more than 20 of patients are still dissatisfied mainly due to reports of ongoing pain Pain control following knee surgery is important in order to allow patients to engage in recovery and rehabilitation The current standard of pain management after surgery centers around the use of opioids which is a concerning practice as highlighted by the opioid epidemic Duloxetine is an antidepressant that has pain relieving properties and it has been studied in patients undergoing knee replacement surgery Studies to date have not been designed optimally to demonstrate the full effects of opioid dose reduction and the use of duloxetine as a medication following knee replacement surgery This research study seeks to start duloxetine before surgery at the recommended therapeutic dose and for the duration of the early rehabilitation period If the study is successful this low-cost medication can improve satisfaction rates and change the standard way the pain management is typically carried out for patients undergoing the knee replacement surgery
Detailed Description:
The use of duloxetine around the time of total knee arthroplasty has emerged as a promising intervention to help with pain management after surgery and in particular as an opioid sparing agent Duloxetine is an antidepressant with serotonin and norepinephrine reuptake inhibition effects that also independently exerts an analgesic effect Duloxetine is Health Canada approved for several indications including pain arising from osteoarthritis of the knee Pain inhibition action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system Existing studies examining duloxetine use at the time of surgery has demonstrated statistically significant but less clinically meaningful impacts on opioid sparing and pain reduction The deficiencies in study design of existing studies have either underdosed duloxetine 30mg instead of the recommended 60mg andor utilized non-standard duration of therapy started too late continued for only 2 weeks Our study seeks to definitively address whether duloxetine administered 2 weeks preoperatively at 60mg once daily in addition to standard analgesic practice will decrease opioid consumption at 1 week postoperatively
Prospective randomized blinded investigators clinicians participant data collectorsanalysts trial
Primary Outcome
Cumulative opioid consumption at 1 week post-operatively
Secondary Outcomes
Nauseavomiting
Discharged according to plan ie same day went home same day or day 1 went home day 1 and if not reason
Pain at rest and with activity NRS-11 at 1 6 and 12 weeks and 45 months
Additional analgesic use anti-neuropathic medications family physician or orthopaedic surgeon opioid prescription
Physical function BPI Oxford Knee Scale range of motion
Emotional function GAD-7 PHQ-9 at 6 weeks and 12 weeks
Number of rehabilitation sessions attended in-person or virtual
Patient satisfaction PGIC at 1 6 and 12 weeks after medication initiation
Presence of neuropathic pain S-LANSS at 6 and 12 weeks
Presence of chronic post-surgical pain at 12 weeks based on NRS gt 0
Adverse events relating to study medication dizziness drowsiness nausea vomiting insomnia
Intervention adherence
Interventional medication supply Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery
Standard of care On the day of surgery participants will be premedicated with acetaminophen 1000mg and celecoxib 400mg Per standard of care all participants will receive an ultrasound guided adductor canal catheter bolus ropivacaine 05 10ml This will be followed by a spinal anesthetic with mepivacaine 2 3ml and 10mcg of fentanyl Intraoperative sedation will consist of a propofol infusion titrated to SAS Sedation Agitation Scale of 3-4
All TKAs will be performed using a standard medial parapatellar approach and the same cemented total knee system Tourniquet will be applied and used as part of the case Periarticular local infiltration will be used per standard practice using ropivacaine 02 with 1200 000 epinephrine up to 50ml
Post-surgery Participants will be evaluated on POD-0 POD-1 and POD-2 while in hospital or at home through phone call and at 1 6 and 12 weeks
Participant satisfaction will be assessed using the Patients Global Impression of Change PGIC Scale at 1 6 and 12 weeks post-surgery
Pain scores and opioid consumption will be recorded daily for 1 week post-operatively
Patients will record their pain and opioid consumption on a weekly basis until week 12 post-operatively
Physical function emotional function and presence of neuropathic pain will be collected at 6 and 12 weeks
Active and passive range of motion will be assessed by orthopedic surgeon using goniometer at 6 -1 week and 12 -1 week weeks and 45 month -2 weeks postoperatively
Group 1 Intervention Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery
Group 2 Control Placebo OD for 2 weeks preoperatively then OD for 6 weeks post-surgery
Both Groups
On the day of surgery standard post-anesthetic care unit PACU orderset will be employed and the postoperative analgesic regimen will follow standard of care including acetaminophen 1g QID celecoxib 200mg BID and hydromorphone 1-3mg PO q2h PRN
Nurse administered IV hydromorphone push 03mg followed by IV PCA hydromorphone if pain is not controlled
ACB catheter ropivacaine 015 at 5cchr stopped at 600am on POD-1
Participants will be discharged on POD-0 POD-1 or POD-2 with acetaminophen 1000mg TID celecoxib 100mg BID and hydromorphone 2-4mg PO q4h PRN Patients for same-day discharge POD-0 will have ACB catheter bolus of 10cc of 05 ropivacaine prior to removal
Prospective randomized blinded investigators clinicians participant data collectorsanalysts trial
Primary Outcome
Cumulative opioid consumption at 1 week post-operatively
Secondary Outcomes
Nauseavomiting
Discharged according to plan ie same day went home same day or day 1 went home day 1 and if not reason
Pain at rest and with activity NRS-11 at 1 6 and 12 weeks and 45 months
Additional analgesic use anti-neuropathic medications family physician or orthopaedic surgeon opioid prescription
Physical function BPI Oxford Knee Scale range of motion
Emotional function GAD-7 PHQ-9 at 6 weeks and 12 weeks
Number of rehabilitation sessions attended in-person or virtual
Patient satisfaction PGIC at 1 6 and 12 weeks after medication initiation
Presence of neuropathic pain S-LANSS at 6 and 12 weeks
Presence of chronic post-surgical pain at 12 weeks based on NRS gt 0
Adverse events relating to study medication dizziness drowsiness nausea vomiting insomnia
Intervention adherence
Interventional medication supply Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery
Standard of care On the day of surgery participants will be premedicated with acetaminophen 1000mg and celecoxib 400mg Per standard of care all participants will receive an ultrasound guided adductor canal catheter bolus ropivacaine 05 10ml This will be followed by a spinal anesthetic with mepivacaine 2 3ml and 10mcg of fentanyl Intraoperative sedation will consist of a propofol infusion titrated to SAS Sedation Agitation Scale of 3-4
All TKAs will be performed using a standard medial parapatellar approach and the same cemented total knee system Tourniquet will be applied and used as part of the case Periarticular local infiltration will be used per standard practice using ropivacaine 02 with 1200 000 epinephrine up to 50ml
Post-surgery Participants will be evaluated on POD-0 POD-1 and POD-2 while in hospital or at home through phone call and at 1 6 and 12 weeks
Participant satisfaction will be assessed using the Patients Global Impression of Change PGIC Scale at 1 6 and 12 weeks post-surgery
Pain scores and opioid consumption will be recorded daily for 1 week post-operatively
Patients will record their pain and opioid consumption on a weekly basis until week 12 post-operatively
Physical function emotional function and presence of neuropathic pain will be collected at 6 and 12 weeks
Active and passive range of motion will be assessed by orthopedic surgeon using goniometer at 6 -1 week and 12 -1 week weeks and 45 month -2 weeks postoperatively
Group 1 Intervention Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery
Group 2 Control Placebo OD for 2 weeks preoperatively then OD for 6 weeks post-surgery
Both Groups
On the day of surgery standard post-anesthetic care unit PACU orderset will be employed and the postoperative analgesic regimen will follow standard of care including acetaminophen 1g QID celecoxib 200mg BID and hydromorphone 1-3mg PO q2h PRN
Nurse administered IV hydromorphone push 03mg followed by IV PCA hydromorphone if pain is not controlled
ACB catheter ropivacaine 015 at 5cchr stopped at 600am on POD-1
Participants will be discharged on POD-0 POD-1 or POD-2 with acetaminophen 1000mg TID celecoxib 100mg BID and hydromorphone 2-4mg PO q4h PRN Patients for same-day discharge POD-0 will have ACB catheter bolus of 10cc of 05 ropivacaine prior to removal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None