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

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical study is to improve upon the standard practice of utilizing nerve blocks to enhance the satisfaction of patients undergoing shoulder, or foot and ankle surgery regarding their quality of pain control, the duration of their nerve blocks, as well as the avoidance of opioid medications and subsequently their undesirable side effects. The researchers hypothesize that dexmedetomidine and dexamethasone (Dex-Dex) will work synergistically as adjuncts in a low, non-weight based formula. This would allow the investigators to improve patient satisfaction by providing them with a superior means of pain control that is longer in duration with a decreased probability of unwanted side effects.

The proposed clinical study will be a prospective, randomized control trial.

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+