Ankle SurgeryQoR - CHEVILLENCT07814937
Quality of Recovery at Days 5-7 After Ankle Surgery: a Multicenter Study in Seine-Maritime
An observational study of Ankle Surgery, run by University Hospital, Rouen at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Surgery
- What is being tested?
- Assessment of recovery quality on days 5-7 after ankle surgery
- How many people
- 260 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Oct 2026to 3 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient requiring ankle surgery (unimalleolar, bimalleolar, or trimalleolar fracture; osteosynthesis; tibiotalar or subtalar arthrodesis, etc.)
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Department of Anesthesiology and Intensive Care
Dieppe, 76200
Maximilien MU URLI, Doctor, 07 69 35 49 80 ext. °33, Murli@ch-dieppe.fr
Department of Anesthesiology and Intensive Care
Elbeuf, 76231
Antoine AT TAMARELLE, Doctor, 06 48 61 96 54 ext. +33, antoine.tamarelle@chu-rouen.fr
Department of Anesthesiology and Intensive Care
Le Havre, 76600
Stellina SC CASTEL, Doctor, 07.67.31.34.48 ext. +33, s.bourdon-castel@ch-havre.fr
Department of Anesthesiology and Intensive Care
Rouen, 76031
Arthur AW WILDEMERSCH, Doctor, 02 32 88 82 92 ext. +33, arthur.wildemersch@chu-rouen.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Surgery
- Being tested
- Assessment of recovery quality on days 5-7 after ankle surgery
- Keywords
- the quality of postoperative recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of recovery quality on days 5-7 after ankle surgeryOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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).
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion3 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur AW WILDEMERSCH, Doctor, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814937
- Sponsor's protocol ID
- 2026/0232/OB
- Other IDs
- 2026-A01395-46
- Acronym
- QoR - CHEVILLE
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery at Days 5-7 After Ankle Surgery: a Multicenter Study in Seine-Maritime Comparing Peripheral Nerve Block and Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07814937
- Acronym / sponsor ID
- QoR - CHEVILLE / 2026/0232/OB
- Conditions
- Ankle Surgery
- Keywords
- the quality of postoperative recovery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 3 May 2028 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient requiring ankle surgery (unimalleolar, bimalleolar, or trimalleolar fracture; osteosynthesis; tibiotalar or subtalar arthrodesis, etc.)
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of recovery quality on days 5-7 after ankle surgeryAssessment 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. | Other | – |
Primary outcome
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.
Time frame: 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).
4 secondary outcomes
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.
Time frame: 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)
Time frame: between 5 and 7 days
Assessment of the neuropathic component of pain at days 5-7 (DN4i score, proportion of DN4i ≥ 3).
Time frame: between 5 and 7 days
Compare analgesic consumption between Day 0 and Days 5-7 (non-opioid and opioid analgesics)
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthur AW WILDEMERSCH, Doctor principal investigator
University Rouen Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Surgery, run by University Hospital, Rouen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabila NL LAAJAIL, Director (02 32 88 82 65 ext. +33, nabila.laajail@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: between 5 and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.