The Effectiveness of the Addition of Dexmedetomidine to Analgesia for Ankle Surgery. (NCT02170948) | Clinical Trial Compass
TerminatedNot Applicable
The Effectiveness of the Addition of Dexmedetomidine to Analgesia for Ankle Surgery.
Stopped: Recruitment was very low
Canada12 participantsStarted 2014-04
Plain-language summary
Forefoot surgeries involve a relatively short operation usually completed in 1 - 1½ hours, with patients generally being allowed to go home on the same day. Despite this, post-surgery pain is often severe and a delay in the discharge of patients due to difficulty with pain control after the surgery is common.
Performing nerve blocks in association with sedation is the preferred way to provide pain relief and offers important benefits for foot surgeries. With nerve blocks, the requirement for oral painkillers and their associated side effects is reduced. Increasing the duration of local anesthetic action is helpful as it increases the time of pain relief, allowing for a smoother transition to oral pain medications, earlier discharge, and faster recovery.
Recently, Precedex has been considered for its usefulness in prolonging the pain relief produced by nerve blocks. The identified benefits of this particular use include reducing post-surgical pain medications requirements, reducing the incidence of nausea and vomiting, reducing the incidence of sedation from such medication, and diminishing the incidence of respiratory depression (inadequate breathing). Two small studies have also shown that adding dexmedetomidine to nerve block solution results in prolonging pain relief.
The purpose of the study is to examine several doses of dexmedetomidine combined with local anesthetic drugs and determine the best combination for prolonging pain relief, while minimizing potential side effects.
Who can participate
Age range
18 Years – 65 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:
* English Speaking
* American Society of Anesthesiologists (ASA) I-III patients
* Ages 18-65
* Body Mass Index (BMI) ≤ 38 kg/m2
Exclusion Criteria:
* Preexisting neurological deficits or peripheral neuropathy in the distribution of the sciatic or femoral nerves
* Known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
* Baseline line heart rate \< 60 Beats Per Minute (BPM) or baseline systolic blood pressure \< 100 mm Hg
* Medications that reduce heart rate
* Known liver or renal dysfunction or existing diseases affecting these organs
* Local infection
* Contraindication to regional anesthesia
* Chronic pain disorders
* History of use of over 30mg oxycodone or equivalent per day
* Contraindication to a component of multi-modal analgesia
* Allergy to local anesthetics or dexmedetomidine
* History of significant psychiatric conditions that may affect patient assessment
* Pregnancy
* Inability to provide informed consent
* Patient refusal
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
Duration of Analgesia
Timeframe: patients will be followed for two weeks