Dexmedetomidine + Dexamethasone for Postoperative Pain

(Dex-Dex PNB Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Arizona

Must not be taking: Opioids, Alcohol

Disqualifiers: Severe organ dysfunction, Severe psychiatric, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks better methods for managing pain after shoulder, foot, or ankle surgery. Researchers are testing whether adding dexmedetomidine (a sedative) and dexamethasone (a corticosteroid) to a nerve block can enhance pain control and reduce the need for opioids, which often cause side effects. The study compares this new drug combination to the standard treatment to determine which is more effective. Individuals scheduled for shoulder or foot and ankle surgeries who can independently perform daily activities may be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research aims to understand the treatment's effects and measure its effectiveness in an initial, smaller group, offering participants an opportunity to contribute to advancements in pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining dexmedetomidine and dexamethasone can enhance pain relief after surgery. One study found that this combination controls pain longer than dexamethasone alone or a placebo, indicating its effectiveness.

Regarding safety, another study examined the addition of dexmedetomidine to local painkillers. It found improved pain levels without significant side effects, suggesting the treatment is generally well-tolerated.

As this trial is in its early stages, it continues to assess the treatment's safety and effectiveness. However, existing research suggests the combination is likely safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of dexamethasone and dexmedetomidine for postoperative pain management because it offers potential advantages over standard treatments like ropivacaine alone. Unlike traditional nerve blocks that typically use ropivacaine and dexamethasone, the addition of dexmedetomidine introduces a novel mechanism. Dexmedetomidine is known for its sedative and pain-relief properties, which can enhance the effectiveness of pain management while potentially reducing the need for opioids. This combination could lead to better pain control with fewer side effects, making recovery more comfortable for patients.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare two different nerve block formulations for postoperative pain relief. Research has shown that combining dexamethasone and dexmedetomidine can significantly enhance pain relief after surgery. Participants in the study group will receive nerve blocks containing both dexamethasone and dexmedetomidine, which have provided longer pain relief than dexamethasone alone. Specifically, dexamethasone extends pain relief from nerve blocks by about six hours, while dexmedetomidine adds another four hours. Studies also suggest that this combination can reduce the need for opioids, which are strong painkillers with unwanted side effects. In summary, using both dexamethasone and dexmedetomidine may offer longer-lasting pain relief and lessen the need for other pain medications. ^{1 2 4 6 7}

Who Is on the Research Team?

Ronald Tang, MD

Principal Investigator

University of Arizona - Banner Health

Are You a Good Fit for This Trial?

This trial is for patients undergoing shoulder, foot, or ankle surgery who want better pain control and wish to avoid opioids. Participants should not have conditions that exclude them from the study as per the unspecified exclusion criteria.

Inclusion Criteria

Speaks and understands English

I am scheduled for foot, ankle, or shoulder surgery.

Regular access to the internet

Exclusion Criteria

Chronic opioid use, alcohol abuse, or any other substance abuse

I need surgery as soon as possible.

I am either younger than 18 or older than 75.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peripheral nerve blocks with Ropivacaine, Dexamethasone, and optionally Dexmedetomidine during surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain control, nerve block duration, and side effects for 7 days postoperatively

7 days

Daily electronic surveys

Data Collection

Collection of data on pain medication usage and side effects through surveys and PACU monitoring

7 days

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Dexmedetomidine

Trial Overview The study tests if a low dose of Dexmedetomidine and Dexamethasone (Dex-Dex), regardless of patient weight, can prolong nerve blocks after surgery. It's a randomized trial comparing this new approach with standard treatments.

How Is the Trial Designed?

Group I: Study Group: nerve blocks containing Ropivacaine, Dexamethasone, and Dexmedetomidine Experimental Treatment 1 Intervention

Ropivacaine local anesthetic solution with 4mg Dexamethasone AND 25mcg Dexmedetomidine added

Group II: Control Group: nerve blocks containing Ropivacaine and Dexamethasone only Experimental Treatment 1 Intervention

Ropivicaine peripheral nerve block solution with 4mg Dexamethasone adjunct

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11984028/

Improvement in postoperative pain control by combined use of ... Dexamethasone can prolong the analgesic time of nerve block for about 6 h, dexmedetomidine for about 4 h [2], and the combined use could be ...

2. rapm.bmj.com rapm.bmj.com/content/50/4/311

a systematic review with meta-analysis and trial sequential ... Combined dexamethasone and dexmedetomidine likely increased the duration of analgesia when compared with placebo and dexmedetomidine.

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1593574/full

Effect of varying doses of dexmedetomidine added to ... This study demonstrated that combining varying doses of dexmedetomidine with dexamethasone in transversus abdominis plane block (TAPB) significantly improved ...

4. clinicalpainadvisor.com clinicalpainadvisor.com/news/dexamethasone-dexmedetomidine-pediatric-nerve-block-analgesia/

Dexamethasone and Dexmedetomidine Prolong Analgesia ... Study finds perineural dexamethasone and dexmedetomidine significantly prolong analgesia and reduce opioid use in children receiving ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11468391/

Dexmedetomidine and Dexamethasone as Adjuvants to the ... The combination of ropivacaine, dexmedetomidine, and dexamethasone in RISS block significantly prolongs the duration of postoperative analgesia following VATS.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1015958425025989

Efficacy and safety of intra-articular dexmedetomidine in ... The main purposes of this study were to compare the efficacy and safety of adding intra-articular dexmedetomidine as an adjunct to local ...

7. journals.lww.com journals.lww.com/md-journal/fulltext/2018/11160/dexmedetomidine_combined_with_local_anesthetics_in.31.aspx

Dexmedetomidine combined with local anesthetics in ... We identified 7 trials enrolling 350 patients and found that DEX reduced pain scores at rest by standardized mean differences (SMD) −0.86 cm (95% confidence ...