Duloxetine for Postoperative Pain After Knee Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Rush University Medical Center
Must not be taking: SSRIs, SNRIs, Serotonergic drugs
Disqualifiers: Psychiatric disorders, Heavy alcohol, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing if duloxetine can help reduce pain and opioid use in patients after knee replacement surgery. It focuses on patients who often have severe pain or heightened pain sensitivity. Duloxetine may work by altering brain chemicals to lessen pain signals. Duloxetine has been shown to have significant pain-relieving effects for managing chronic pain associated with conditions like fibromyalgia and diabetic peripheral neuropathic pain.
Will I have to stop taking my current medications?
The trial requires that you have not used SSRIs, SNRIs, or serotonergic drugs (except tramadol) in the past 6 months. If you are taking these medications, you would need to stop before participating.
What data supports the effectiveness of the drug duloxetine for postoperative pain after knee surgery?
Research shows that duloxetine can help reduce the need for opioids (strong painkillers) and lower pain levels after knee surgery. It has been effective in managing pain for patients with central sensitization (a condition where the nervous system is more sensitive to pain) after knee replacement surgery.
12345Is duloxetine safe for humans when used for postoperative pain after knee surgery?
Duloxetine is generally safe for humans, but it may cause some side effects like insomnia, while reducing nausea and vomiting compared to a placebo. It has been studied for various conditions, showing it can help manage pain with a good safety profile.
34567How does the drug duloxetine differ from other treatments for postoperative pain after knee surgery?
Duloxetine is unique because it is a serotonin and norepinephrine reuptake inhibitor (SNRI) that not only helps reduce postoperative pain but also decreases the need for opioids and enhances patient satisfaction after knee surgery. Unlike traditional painkillers, it may also lower wound temperature and is generally safe with manageable side effects like headache and nausea.
358910Eligibility Criteria
This trial is for adults under 80 years old who are having a knee replacement due to osteoarthritis and can speak English. They must be willing to follow the study plan and return for check-ups. People with severe health issues, mental disorders, heavy alcohol use, opioid tolerance, or kidney problems cannot join.Inclusion Criteria
English speaking
I am 18 years old or older.
Willingness to undergo randomization and return for all scheduled visits
+1 more
Exclusion Criteria
Non-English speaking
Non-independent (i.e. requires a caretaker to make medical decisions on their behalf)
I have been taking at least 60 morphine equivalents daily for the last 3 months.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-surgery Treatment
Participants in the experimental arm receive 30 mg of duloxetine daily starting one week prior to surgery
1 week
Post-surgery Treatment
Participants continue to receive 30 mg of duloxetine daily for 6 weeks following surgery
6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse medication effects and patient-reported outcomes
Up to 3 months
Participant Groups
The trial tests if duloxetine reduces pain and opioid need after knee surgery compared to a placebo (a pill without medicine). It also looks at how it affects patient-reported outcomes. Participants will be randomly assigned to either receive duloxetine or a placebo.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DuloxetineExperimental Treatment1 Intervention
Patients randomized to the experimental arm of the study will receive 30 mg of duloxetine and will be advised to consume the medication orally (per os \[PO\]) daily starting one week prior to surgery and to continue until 6 weeks following surgery. The dose of 30 mg was selected as that has been used as that is the largest starting dose used in other RCTs without requiring a preceding adjustment period at a lower dosage.
Group II: ControlPlacebo Group1 Intervention
Patients randomized to the control arm will receive PO-matched placebo tablets and advised to consume their medication similar to the treatment arm. Both groups of patients will receive their medications from the pharmacy at Rush Medical Center, which will be responsible for providing patients with the appropriate regimen. All patients will receive the same postoperative multimodal analgesic regimen that is normally administered as part of conventional care to patients undergoing TKA at Rush University Medical Center.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University medical CenterChicago, IL
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Who Is Running the Clinical Trial?
Rush University Medical CenterLead Sponsor
References
The effects of a short-term perioperative duloxetine treatment on post-colectomy pain: A randomized, controlled clinical trial. [2022]To test the hypothesis that duloxetine reduces postoperative morphine consumption and pain intensity in patients undergoing major colonic surgeries.
Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial. [2021]Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group.
Analgesic effect of perioperative duloxetine in patients after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. [2022]To investigate the analgesic effect of perioperative use of duloxetine in patients received total knee arthroplasty (TKA).
Duloxetine for the reduction of opioid use in elective orthopedic surgery: a systematic review and meta-analysis. [2021]Background Duloxetine is currently approved for chronic pain management; however, despite some evidence, its utility in acute, postoperative pain remains unclear Aim of the review This systematic review and meta-analysis is to determine if duloxetine 60 mg given perioperatively, is safe and effective at reducing postoperative opioid consumption and reported pain following elective orthopedic surgery. Method CINAHL, Medline, Cochrane Central Registry for Clinical Trials, Google Scholar, and Clinicaltrials.gov were searched using a predetermined search strategy from inception to January 15, 2019. Covidence.org was used to screen, select, and extract data by two independent reviewers. Individual study bias was assessed using the Cochrane Risk of Bias tool. Opioid consumption data were converted to oral morphine milligram equivalents (MME) and exported to RevMan where meta-analysis was conducted using a DerSimonian and Laird random effects model. Results Six randomized-controlled trials were included in the literature review of postoperative pain and adverse effects. Five studies were utilized for the meta-analysis of postoperative opioid consumption; totaling 314 patients. Postoperative pain analysis showed variable statistical significance with overall lower pain scores with duloxetine. Adverse effects included an increase in insomnia with duloxetine but lower rates of nausea and vomiting. Meta-analysis revealed statistically significant [mean difference (95% CI)] lower total opioid use with duloxetine postoperatively at 24 h [- 31.9 MME (- 54.22 to - 9.6), p = 0.005], 48 h [- 30.90 MME (- 59.66 to - 2.15), p = 0.04] and overall [- 31.68 MME (- 46.62 to - 16.74), p
Perioperative duloxetine administration reduces pain after high tibial osteotomy and non-steroidal anti-inflammatory administration: A prospective, controlled study. [2022]Postoperative pain management is essential for patient satisfaction; however, no reports have described the effect of perioperative duloxetine administration on the postoperative pain management following knee surgery. This study aimed to determine whether perioperative duloxetine administration reduces pain following high tibial osteotomy.
Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: a 13-week, randomized, placebo-controlled trial. [2022]Pain is a common cause of disability in osteoarthritis. Duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), has demonstrated analgesic effects in diabetic peripheral neuropathy and fibromyalgia. Considering its central mechanism of action, duloxetine may be effective in other pain states with evidence of central sensitization. Herein, we report the results of a 13-week, randomized, double-blind, placebo-controlled trial of duloxetine (60-120 mg/day) versus placebo in the treatment of knee pain in 231 patients meeting clinical and radiographic criteria for osteoarthritis of the knee. Duloxetine was superior to placebo on the primary efficacy measure (weekly mean 24-h pain scores) beginning at Week 1 and continuing through the treatment period (P
Postoperative acute pain management with duloxetine as compared to placebo: A systematic review with meta-analysis of randomized clinical trials. [2023]Duloxetine has been used as an adjunct in multimodal analgesia for acute postoperative pain in clinical studies. This meta-analysis aims to conclude whether oral duloxetine, when given perioperatively, is any better than a placebo in managing postoperative pain. Effects of duloxetine on postoperative pain scores, time to first rescue analgesia, postoperative rescue analgesia consumption, side effects attributable to duloxetine, and patient satisfaction profile were assessed.
The analgesic effect and safety of duloxetine in total knee arthroplasty: A systematic review. [2023]Background: Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) with clinical efficacy in chronic pain conditions. In this study, we aim to evaluate the analgesic effect and safety of duloxetine in total knee arthroplasty (TKA). Methods: A systematic search was completed on MEDLINE, PsycINFO, and Embase from inception to December 2022 to find relevant articles. We used Cochrane methodology to evaluate the bias of included studies. Investigated outcomes included postoperative pain, opioid consumption, adverse events (AEs), range of motion (ROM), emotional and physical function, patient satisfaction, patient-controlled analgesia (PCA), knee-specific outcomes, wound complications, skin temperature, inflammatory markers, length of stay, and incidence of manipulations. Results: Nine articles involving 942 participants were included in our systematic review. Out of nine papers, eight were randomized clinical trials and one was a retrospective study. The results of these studies indicated the analgesic effect of duloxetine on postoperative pain, which was measured using numeric rating scale and visual analogue scale. Deluxetine was also effective in reducing the morphine requirement and wound complications and enhancing patient satisfaction after surgery. However, the results on ROM, PCA, and knee-specific outcomes were contraventional. Deluxetine was generally safe without serious AEs. The most common AEs included headache, nausea, vomiting, dry mouth, and constipation. Conclusion: Duloxetine may be an effective treatment option for postoperative pain following TKA, but further rigorously designed and well-controlled randomized trials are required.
Preemptive Duloxetine Relieves Postoperative Pain and Lowers Wound Temperature in Centrally Sensitized Patients Undergoing Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. [2021](1) Background: The purpose of this study was to determine whether preemptive duloxetine in patients with central sensitization (CS) is effective for acute postoperative pain control and wound healing following total knee arthroplasty (TKA). (2) Methods: CS was defined as a score of 40 points or higher on the Central Sensitization Inventory (CSI) survey. Thirty-nine patients with CS were randomly assigned to either the duloxetine group (n = 19) or the placebo group (n = 20). The duloxetine group took duloxetine 30 mg once a day, while the placebo group took the placebo medication once a day. A pain visual analog scale (VAS) and the Brief Pain Inventory (BPI), wound complications, the temperature of the surgical site, and adverse events were investigated. Skin temperature was measured at the center of the patella using a portable digital thermometer. (3) Results: The duloxetine group reported significantly lower pain VAS scores during follow-up periods up to 6 weeks after surgery (all p < 0.05). BPI interference also showed significantly superior results in the duloxetine group after surgery (all p < 0.05). Although there was no difference in the rate of wound complications between the two groups (p > 0.05), the duloxetine group showed significantly lower wound temperature than the placebo group during the follow-up period (all p < 0.05). (4) Conclusion: In this study, preemptive duloxetine effectively reduced pain and lowered wound temperature following TKA in CS patients.
Duloxetine for rehabilitation after total knee arthroplasty: a systematic review and meta-analysis. [2023]The aim was to evaluate the efficacy and safety of duloxetine for postoperative recovery after total knee arthroplasty.