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

ConditionAnkle Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial population

patient requiring ankle surgery (unimalleolar, bimalleolar, or trimalleolar fracture; osteosynthesis; tibiotalar or subtalar arthrodesis, etc.)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

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).

Time frame
between 5 and 7 days

Secondary outcomes

1

Describe and compare the QoR-15F score at days 5-7 across three groups: truncal block, spinal anesthesia, and genOverall QoR-15F score at days 5-7 across the three groups (truncal block, spinal anesthesia, general anesthesia), and analysis of sub-scores.

Overall QoR-15F score at days 5-7 across the three groups (truncal block, spinal anesthesia, general anesthesia), and analysis of sub-scores. 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).

Time frame
between 5 and 7 days
2

Compare pain at days 5-7 between groups (NRS 0-10 at rest and during mobilization, proportion of NRS > 3)

Pain assessment at days 5-7 (NRS at rest and during mobilization), proportion of patients of NRS \> 3. It is a scale from 0 to 10 that allows the patient to quantify the intensity of the pain. (0 No pain, 1-3 Mild pain, 4-6 Moderate pain, 7-9 Severe pain, 10 Worst pain)

Time frame
between 5 and 7 days
3

Assessment of the neuropathic component of pain at days 5-7 (DN4i score, proportion of DN4i ≥ 3).

The DN4i score, corresponding to the DN4 intervie, is used to screen for a neuropathic component of pain. The DN4i comprises 7 items corresponding to symptoms reported by the patient : 1. Burning, 2. Painful sensation of cold, 3. Electric shocks, 4. Pins and needles, 5. Tingling, 6. Numbness, 7. Itching. For each item : Yes = 1 point and No = 0 points. DN4i score = number of "Yes" answers. Score \< 3: neuropathic pain less likely; Score ≥ 3/7: probable neuropathic pain present.

Time frame
between 5 and 7 days
4

Compare analgesic consumption between Day 0 and Days 5-7 (non-opioid and opioid analgesics)

The aim is to question the patient about their cumulative analgesic consumption between Day 0 and Days 5-7 (Step I to III analgesics, specific drugs, and dosages).

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Source ClinicalTrials.gov

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