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

NCT07814937 | Not Yet Recruiting

• 2 other identifiers: 2026/0232/OB2026-A01395-46
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ankle Surgery

Keywords

the quality of postoperative recovery

Outcome Measures

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).

  between 5 and 7 days

Secondary Outcomes (4)

• 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.

  between 5 and 7 days

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

  between 5 and 7 days

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

  between 5 and 7 days

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

  7 days

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (4)

Department of Anesthesiology and Intensive Care

Dieppe, 76200, France

Location

Department of Anesthesiology and Intensive Care

Elbeuf, 76231, France

Location

Department of Anesthesiology and Intensive Care

Le Havre, 76600, France

Location

Department of Anesthesiology and Intensive Care

Rouen, 76031, France

Location

Study Officials

• Arthur AW WILDEMERSCH, Doctor

  University Rouen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabila NL LAAJAIL, Director

CONTACT

02 32 88 82 65; nabila.laajail@chu-rouen.fr

Vincent VF FERRANTI, ARC

CONTACT

02 32 88 82 65; Vincent.ferranti@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 11, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 3, 2028
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)