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Starting soon Observational

Quality of Recovery at Days 5-7 After Ankle Surgery: a Multicenter Study in Seine-Maritime

NCT07814937 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-10-01
Last updated
2026-09-11

Condition(s) studied

Ankle Surgery

Investigational drug(s) / intervention(s)

Assessment of recovery quality on days 5-7 after ankle surgery

Assessment of recovery quality on days 5-7 after ankle surgery: Assessment of patient recovery following ankle surgery and anesthesia by collecting clinical monitoring data intraoperatively, and postoperatively estimates of pain, the neuropathic component of pain, analgesic consumption, and satisfaction with medical care.

Study summary

Ankle fractures are among the most common fractures in trauma care, with an estimated annual incidence of 100 to 150 per 100,000 inhabitants and a marked increase after age 40. These fractures affect both young individuals-typically following high-energy trauma-and older adults-often resulting from low-energy falls-with a female predominance in the latter group. Surgical fixation (for bi-malleolar, tri-malleolar, or unstable fractures) remains the gold standard for displaced or unstable injuries, requiring appropriate anesthetic management.

Ankle surgery is recognized as one of the most painful orthopedic procedures in the postoperative period, due to extensive local innervation and significant tissue edema. Despite advances in multimodal analgesia protocols-incorporating paracetamol, nefopam, non-steroidal anti-inflammatory drugs (NSAIDs), and corticosteroids-postoperative pain remains inadequately controlled in a significant proportion of patients. Persistent pain after discharge is associated with a twofold increase in the risk of emergency department visits or hospital readmission, highlighting the clinical and socioeconomic impact of insufficient postoperative analgesia.

Furthermore, postoperative pain following ankle surgery is not limited to a nociceptive component. Intraoperative nerve injuries (such as traction neuropraxia or compression caused by edema or fixation hardware) can induce a neuropathic component, which is frequently underestimated in clinical practice.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years. * Ankle surgery (uni-, bi-, or trimalleolar fracture; osteosynthesis; tibiotalar or subtalar arthrodesis, etc.). * Elective or emergency surgery. * Anesthesia via nerve block, spinal anesthesia, or general anesthesia. * Ability to understand French and answer a questionnaire by telephone. * Patient informed and having expressed no objection to the research (non-objection). Exclusion Criteria: * Under 18 years of age. * Inability to perform central or peripheral regional anesthesia due to acquired or congenital hemostasis disorders, use of antiplatelet agents, or other contraindications to regional anesthesia. * Surgery not involving the ankle or foot. Pure local anesthesia administered by the surgeon without an anesthesiologist. * Major cognitive impairment or inability to respond (language barrier, severe uncorrected deafness, etc.). * Patient under legal guardianship, curatorship, judicial protection, or deprived of liberty. * Explicit refusal to participate.

Primary outcome measure(s)

  • To compare recovery quality on postoperative days 5-7, measured by the global QoR-15F score, between patients undergoing surgery under truncal regional anesthesia and those undergoing surgery under spinal anesthesia. — between 5 and 7 days
    Calculation of the global QoR-15F score on postoperative days 5-7 (range: 0-150), comparing the truncal regional anesthesia group with the spinal anesthesia group. The QoR-15F consists of 15 questions, each rated on a scale of 0 to 10. (0 = very poor state / severe symptom and 10 = best possible state). The total score is therefore obtained by summing the 15 responses : QoR-15F score = Q1 + Q2 + Q3 + … + Q15. (150 → optimal recovery; high score → good quality of recovery; low score → more difficult recovery, with more symptoms or limitations).

Trial sites (4)

FacilityCityRegionStatus
Department of Anesthesiology and Intensive Care Dieppe France
Department of Anesthesiology and Intensive Care Elbeuf France
Department of Anesthesiology and Intensive Care Le Havre France
Department of Anesthesiology and Intensive Care Rouen France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07814937 on ClinicalTrials.gov ↗ ← All trials in France