Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks (NCT07099222) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks
United States100 participantsStarted 2024-10-10
Plain-language summary
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 can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peripheral Nerve Block Duration
Timeframe: 0-7 days
2
Post-operative pain scores
Timeframe: 0-7 days
3
Pain medicine (opioid and non-opioid) consumption post-operatively