CompletedPhase 4

The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery

Denmark18 participantsStarted 2016-06-21

Plain-language summary

The study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

Who can participate

Age range

18 Years – 85 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: * Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis or (4) triple arthrodesis * Age ≥ 18 * American Society of Anaesthesiology Classification I-III * Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations. Exclusion Criteria: * Communication problems or dementia * Allergies to any medical product used in the study * Neuropathy of the sciatic or femoral nerve prior to the operation * Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease * Daily use of opioids * Coagulation disorders * Infection at the site of injection or systemic infection

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

Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain)

Timeframe: Arrival at the Perioperative Section (within 30 minutes after surgery) and at t = 30 min, t = 45 min, t = 60 min, t = 75 min, t = 90 min, t = 105 min, t = 120. The beginning of the observation period (t0) is the registered time for the end of surgery.

Trial details

NCT IDNCT02697955

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-28

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