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

Quality of Recovery at Days 5-7 After Ankle Surgery: a Multicenter Study in Seine-Maritime Comparing Peripheral Nerve Block and Spinal Anesthesia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Surgery
• Intervention / Treatment: Other: Assessment of recovery quality on days 5-7 after ankle surgery

Detailed Description

Anesthetic management for ankle surgery relies on three main options: general anesthesia (GA), neuraxial regional anesthesia (spinal anesthesia), and truncal regional anesthesia via peripheral nerve blocks of the lower limb.

General anesthesia remains the most widely used technique in many centers. However, it carries a risk of common adverse effects (postoperative nausea and vomiting, drowsiness, unexpected pain upon awakening) and does not provide prolonged residual analgesia.

Spinal anesthesia offers rapid, reliable sensory and motor blockade of the lower limb and is quick to perform. Nevertheless, it can be associated with specific side effects: arterial hypotension, urinary retention, post-puncture lower back pain, and-more rarely-post-dural puncture headache. These effects can delay functional recovery and compromise patient comfort.

Peripheral nerve blocks of the lower limb (such as the popliteal sciatic nerve block, saphenous or femoral nerve block, or combinations like the HabiBloc) have gained popularity in recent years thanks to ultrasound guidance. They provide targeted, prolonged analgesia with a superior hemodynamic profile (less hypotension, no urinary retention) and the potential to significantly reduce opioid consumption. While postoperative pain remains a fundamental assessment criterion, modern approaches to perioperative medicine increasingly emphasize patient-reported outcomes (PROs)-results reported directly by patients. Factors such as pain, fatigue, sleep quality, functional independence, and satisfaction constitute an essential component of perioperative care, yet one that is not yet sufficiently integrated.

The QoR-15 (Quality of Recovery-15) questionnaire is a validated, concise tool (15 items, score range 0-150) that measures five dimensions of postoperative recovery: physical comfort, physical independence, pain, psychological well-being, and support. A French version has been validated with good psychometric properties, and its validity has been confirmed even in the context of emergency surgery. The minimal clinically important difference for the QoR-15 is estimated at 8 points, making it a sensitive tool for detecting differences in recovery between anesthetic techniques.

A trial by Yoo et al. (2024), comparing combined peripheral nerve block versus spinal anesthesia in 101 patients undergoing below-knee lower-limb surgery, demonstrated that-despite similar pain scores between the groups-peripheral nerve block offered superior physical independence, significantly higher satisfaction, and a markedly higher rate of patients willing to "choose the same anesthesia again." However, the global QoR-15 score at 24 hours did not differ significantly between the two groups; similarly, in the AnAnkle trial, QoR-15 scores at 24 hours were comparable between nerve block and spinal anesthesia. These results suggest that measuring quality of recovery at a later stage (days 5-7)-once the nerve block has worn off and the patient faces the realities of functional recovery at home-might be more discriminatory. Conversely, Droog et al. demonstrated in upper-limb surgery that regional anesthesia was not consistently associated with higher satisfaction; discomfort associated with the nerve block, waiting times, and fear could detract from the overall experience. These findings highlight that satisfaction and quality of recovery are not determined solely by analgesia but depend on the entire care pathway.

The meta-analysis by Lee et al.-the most comprehensive review on the subject-identified only two studies reporting satisfaction as an outcome measure, and none using a standardized quality-of-recovery score as the primary outcome. Similarly, large epidemiological cohort studies on ankle surgery have focused on in-hospital complications and readmissions, without incorporating patient-reported outcomes. Furthermore, existing studies have predominantly compared peripheral nerve blocks with spinal anesthesia without consistently including a general anesthesia-only group, even though the latter remains widely used in routine practice. Finally, almost all available data come from single-center trials conducted in diverse geographic settings; to our knowledge, no French multicenter study has evaluated the quality of recovery following ankle surgery by comparing these three anesthetic techniques.

The aim of this research project is to compare the quality of postoperative recovery at days 5-7, measured by the global QoR-15F score (15-18), between patients undergoing ankle surgery under:

• regional nerve block (peripheral nerve block), and
• spinal anesthesia.

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: Vincent VF FERRANTI, ARC; Phone Number: +33 02 32 88 82 65; Email: Vincent.ferranti@chu-rouen.fr
• Study Contact Backup: Name: Nabila NL LAAJAIL, Director; Phone Number: +33 02 32 88 82 65; Email: nabila.laajail@chu-rouen.fr

Study Locations

• France
  • Dieppe, France, 76200
    • Department of Anesthesiology and Intensive Care
    • Contact: Maximilien MU URLI, Doctor; Phone Number: °33 07 69 35 49 80; Email: Murli@ch-dieppe.fr
  • Elbeuf, France, 76231
    • Department of Anesthesiology and Intensive Care
    • Contact: Antoine AT TAMARELLE, Doctor; Phone Number: +33 06 48 61 96 54; Email: antoine.tamarelle@chu-rouen.fr
  • Le Havre, France, 76600
    • Department of Anesthesiology and Intensive Care
    • Contact: Stellina SC CASTEL, Doctor; Phone Number: +33 07.67.31.34.48; Email: s.bourdon-castel@ch-havre.fr
  • Rouen, France, 76031
    • Department of Anesthesiology and Intensive Care
    • Contact: Arthur AW WILDEMERSCH, Doctor; Phone Number: +33 02 32 88 82 92; Email: arthur.wildemersch@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	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)	between 5 and 7 days
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.	between 5 and 7 days
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).	7 days

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Arthur AW WILDEMERSCH, Doctor, University Rouen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 3, 2028

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: the quality of postoperative recovery
• Other Study ID Numbers: 2026/0232/OB; 2026-A01395-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No