Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Postoperative Pain, Nausea and Vomiting, Postoperative, Dizziness, Constipation, Duration of Response, Narcotics Consumption, Pain After Surgery
In brief
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.
Key facts
- Study ID
- NCT07099222
- Run by
- University of Arizona
- People needed
- 100
- Starts
- 2024-10-10
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-02-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adults (18 years and older but less than 75)
- Speaks and understands English.
- Capable of performing all activities of daily living independently
- Normal development for age and without cognitive impairment
- Weight over 50 kg
- Undergoing scheduled, elective foot, ankle, and shoulder surgery
- Patient is not expected to perform weight-bearing rehabilitation post-op for 1 week.
- Regular access to the internet
You may not qualify if…
- Under 18 or older than 75 years of age
- Pregnancy
- Known allergy to local anesthetics including lidocaine and ropivacaine.
- Known allergy to glucocorticoid steroids or necessary abstinence for medical reasons.
- Known allergy to dexmedetomidine or other α2 agonist derivatives.
- Severe organ dysfunction: end-stage renal disease, liver failure
- Severe psychiatric disease that alters sense of reality and interferes with pain perception.
- Severe cognitive impairment that interferes with pain perception
- Chronic opioid use, alcohol abuse, or any other substance abuse
- Urgent/emergent procedure
- Emergency return to OR after initial surgery
- Infection at block or surgical site
- Hemodynamic instability preoperatively
- Hemodynamic instability during surgery affects timely extubating at the end of surgery.
- Failed nerve blocks that did not end up blocking the nerves as intended, or inadequate nerve blocks requiring repeat rescue blocks in PACU.
Where it is running
- Banner - University Medical Center South — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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