Duloxetine for Pain in Total Hip Arthroplasty

Overseen By Victor Hernandez, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Antidepressants, Cytochrome inhibitors

Disqualifiers: Previous hip surgery, Drug use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 hours

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether duloxetine, a medication commonly used for depression and anxiety, can reduce the need for narcotic painkillers after hip replacement surgery. The trial compares the effectiveness of duloxetine to a placebo, focusing on reducing the total amount of pain medication required. Suitable candidates for this trial are individuals planning their first total hip replacement and who can walk before surgery. As a Phase 4 trial, duloxetine has already received FDA approval and proven effective, and this research aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

If you are taking certain antidepressants or specific enzyme inhibitors, you may need to stop them to participate in this trial. The protocol excludes patients on selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, tricyclic antidepressants, and certain enzyme inhibitors.

What is the safety track record for this treatment?

Research has shown that duloxetine is generally safe for use after surgery. Studies have found it can reduce pain and lessen the need for strong painkillers, such as opioids, without increasing side effects. In these studies, patients taking duloxetine reported less pain and used fewer opioids. No major reports of increased unwanted side effects have emerged when using duloxetine for pain control, suggesting it is well-tolerated by patients post-surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about duloxetine for managing pain after total hip arthroplasty because it offers a different approach compared to traditional painkillers like opioids and NSAIDs. Unlike these standard treatments, which mostly target inflammation or block pain signals broadly, duloxetine works by balancing neurotransmitters in the brain, specifically serotonin and norepinephrine, which can help in modulating pain perception more effectively. This potentially minimizes the reliance on opioids, reducing the risk of addiction and other side effects. Additionally, duloxetine's multitarget mechanism may provide more comprehensive pain relief, making it an attractive option for post-surgical pain management.

What evidence suggests that duloxetine might be an effective treatment for pain after total hip arthroplasty?

This trial will compare duloxetine with a placebo for managing pain in total hip arthroplasty. Studies have shown that duloxetine can reduce the need for opioids and lessen pain after surgery. Specifically, patients who took duloxetine after joint surgery experienced less pain and required fewer opioids, with effects noticeable within three weeks post-surgery. Additionally, patients reported lower pain levels both during movement and at rest. Duloxetine achieved these results without increasing the risk of side effects. Overall, duloxetine appears to be a promising option for managing pain after surgeries like total hip replacement. ^{3 4 6 7 8}

Who Is on the Research Team?

Victor Hernandez, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for English or Spanish speaking adults over 18 who can consent and are having a primary total hip arthroplasty. They must have been able to walk before surgery. It's not for those with severe depression, glaucoma, hip infections, certain drug histories, liver failure, severe kidney issues, or taking specific antidepressants.

Inclusion Criteria

I am over 18 years old.

I can understand and agree to the study's details on my own.

I am having my first total hip replacement surgery.

Exclusion Criteria

Polytrauma

I have uncontrolled narrow angle glaucoma.

I have a hip infection in the same side of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either duloxetine or placebo for perioperative pain control after total hip arthroplasty

Up to 2 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain assessment and musculoskeletal function

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Duloxetine

Trial Overview The study tests if Duloxetine reduces the need for narcotics after hip replacement surgery compared to a placebo. Participants will be randomly assigned to receive either Duloxetine or an inactive pill to assess pain management effectiveness.

How Is the Trial Designed?

Group I: Duloxetine group Experimental Treatment 1 Intervention

Participants will be in this group for up to 2 hours.

Group II: Placebo group Placebo Group 1 Intervention

Participants will be in this group for up to 2 hours.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Duloxetine significantly reduces pain intensity and improves functional outcomes in osteoarthritis patients, as shown in a meta-analysis of five randomized controlled trials involving 2059 patients.

While duloxetine is effective, it is associated with higher rates of treatment-emergent adverse events and discontinuation compared to placebo, although severe adverse events were not significantly different between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short-term effect and safety of duloxetine in osteoarthritis: A systematic review and meta-analysis. Gao, SH., Huo, JB., Pan, QM., et al.[2022]

In a study involving 100 patients undergoing total knee arthroplasty, perioperative use of duloxetine significantly reduced both resting and ambulation pain scores compared to a placebo, indicating its efficacy in managing acute postoperative pain.

Patients taking duloxetine also consumed less opioids post-surgery, suggesting that it can help decrease opioid use without increasing the risk of adverse effects, making it a valuable addition to pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effect of perioperative duloxetine in patients after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. Yuan, M., Tang, T., Ding, Z., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38481321/

Duloxetine reduces opioid consumption and pain after total ... Duloxetine reduced overall opioid consumption in the perioperative period and relieved pain within three weeks after surgery without ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S235234412300002X

Duloxetine for Postoperative Pain Control Following Knee ... Duloxetine appears to decrease postoperative pain and opioid consumption following total joint arthroplasty. However, definitive conclusions are limited by ...

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-04648-5

Duloxetine reduces opioid consumption and pain after total ... Duloxetine reduced overall opioid consumption in the perioperative period and relieved pain within three weeks after surgery without increasing the risk of ...

4. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/93012-antineuropathic-pain-management-after-orthopedic-surgery-a-systematic-review

Antineuropathic Pain Management After Orthopedic Surgery Patients administered duloxetine had significantly lower pain severity scores upon movement and performed better in terms of resting pain (3 ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/08250/the_efficacy_and_safety_of_duloxetine_for_the.34.aspx

The efficacy and safety of duloxetine for the treatment of... Duloxetine could decrease the opioids consumption and relieve early postoperative pain without increasing the risk of adverse medication effects.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9957748/

Duloxetine for Postoperative Pain Control Following Knee or ... In summary, duloxetine appears to safely decrease postoperative pain and opioid consumption following TJA. The major limitations of this study include ...

7. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/1358-992X.2023.11.012

SAFETY AND EFFICACY OF DULOXETINE IN PATIENTS ... The primary outcome was pain reduction with rest and movement at short-term and long-term time intervals. Secondary outcomes were the use of ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37653762/

The efficacy and safety of duloxetine for the treatment ... Duloxetine could decrease the opioids consumption and relieve early postoperative pain without increasing the risk of adverse medication effects.