Hindfoot SurgeryCATHORNOTNCT07638514
Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot Surgery
An observational study of Hindfoot Surgery and Analgesia, run by University Hospital, Angers at 1 site in France.
Trial summary
Postoperative pain following hindfoot surgery is often severe and can persist for several days. It frequently leads to the use of systemic analgesics, particularly opioids, whose adverse effects are well known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hindfoot Surgery, Analgesia, Perineural Catheter
- What is being tested?
- Phone contact, perineural catheter and Regional Anesthesia
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2026to 14 Mar 2027
- 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: University Hospital of Angers
Who may be able to join
- Adult patients;
- Patients with an American Society of Anesthesiologists physical status (ASA score) of 1, 2, or 3;
- Patients who have undergone hindfoot surgery;
- Patients capable of completing the questionnaires.
Who cannot join
- Contraindications to regional anesthesia (known hypersensitivity to the local anesthetic, infection at the injection site, uncontrolled neurological condition);
- Emergency surgery
- Cognitive impairment;
- Uncontrolled psychiatric condition;
- Pregnancy or breastfeeding;
- Substance abuse;
Show all 10Show fewer
- Use of neuroleptics or lithium;
- Individuals subject to legal guardianship
- Individuals deprived of liberty by judicial or administrative order
- Patients who object to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers
Benjamin DUMARTINET, 241353637 ext. +33, benjamin.dumartinet@chu-angers.fr
About this study
Official title: A Comparative Evaluation of Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot Surgery
Postoperative pain following hindfoot surgery is often severe and can persist for several days. It frequently leads to the use of systemic analgesics, particularly opioids, whose adverse effects are well known. Furthermore, poorly controlled postoperative pain is a recognized independent risk factor for the development of chronic pain.
Ambulatory perineural catheter techniques, already used in our department for hindfoot surgeries, allow for continuous infusion of local anesthetic. They have demonstrated their efficacy in numerous orthopedic surgeries, but data specific to hindfoot surgery remain limited. It therefore seems appropriate to evaluate whether prolonged analgesia via a perineural catheter improves postoperative pain management and promotes functional recovery.
The study is conducted as a practice evaluation audit. It relies on the collection of data from routine care, without any modification to intraoperative care. This methodology allows for an objective evaluation of the benefits of the perineural catheter compared to a single-injection popliteal sciatic block with local anesthetic, while documenting the frequency and nature of complications associated with the technique (leaks, accidental or intentional catheter removal).
- Conditions
- Hindfoot Surgery, Analgesia, Perineural Catheter
- Being tested
- Phone contact, perineural catheter, Regional Anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone contactOther
All patients are contacted by phone to assess pain during movement and at rest on each of the first 3 days after surgery, as well as their use of various pain medications
perineural catheterDevice
Use of a perineural catheter for ambulatory analgesia
Regional AnesthesiaProcedure or surgery
regional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| regional anesthesia | Not described Receives: Other: Phone contact; Procedure: Regional Anesthesia | |
| ambulatory perineural catheter | Not described Receives: Other: Phone contact; Device: perineural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on movement using a numerical scale from 0 (no pain) to 10 (maximum pain)
Postoperative pain on movement at Day 1. Pain intensity during movement assessed using an 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst possible pain)
Measured: Day 1 postoperative
Secondary outcomes (10)
postoperative pain at rest using a numerical scale from 0 (no pain) to 10 (maximum pain)
to assess analgesic efficacy at rest
Measured: Postoperative Day 0 through Postoperative Day 3
postoperative pain during mobilization using a numerical scale from 0 (no pain) to 10 (maximum pain)
to evaluate the analgesic efficacy during mobilization
Measured: From Baseline to Day 3
Postoperative consumption of morphine equivalents in milligrams
Cumulative
Measured: Postoperative Day 0 through Postoperative Day 3
Daily postoperative consumption of morphine equivalents in milligrams
Daily
Measured: Baseline, Day 1, Day 2 and Day 3
Postoperative use of non-opioid analgesics
Cumulative
Measured: Postoperative Day 0 through Postoperative Day 3
Daily postoperative use of non-opioid analgesics
Daily
Measured: Baseline, Day 1, Day 2 and Day 3
French Quality of Recovery -15 score (FQoR-15 - from 0 to 150)
to assess functional recovery and postoperative rehabilitation
Measured: Postoperative Day 0 through Postoperative Day 2
Proportion of patients experiencing at least one adverse event related to the regional anesthesia technique
Accidental or intentional removal of the catheter Leaks at the injection site or in the infusion system Bruise or local infection Falls potentially related to the residual motor block
Measured: Postoperative Day 0 through Postoperative Day 3
proportion of patients experiencing at least one postoperative complication following hindfoot surgery
Readmission to the hospital Consultation with the attending physician for uncontrolled postoperative pain or complications related to the procedure Confirmed infection with antibiotic treatment initiated
Measured: Postoperative Day 0 through Postoperative Day 3
length of hospital stay, calculated in whole days
Duration censored on Day 3 if the patient is still hospitalized on that date
Measured: Postoperative Day 0 through Postoperative Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start14 Sep 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hindfoot SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Benjamin DUMARTINET, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638514
- Sponsor's protocol ID
- 49RC26_0116
- Acronym
- CATHORNOT
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot Surgery
- ClinicalTrials.gov ID
- NCT07638514
- Acronym / sponsor ID
- CATHORNOT / 49RC26_0116
- Conditions
- Hindfoot Surgery, Analgesia, Perineural Catheter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Mar 2027 (estimated)
- First posted
- 10 Jun 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.
Postoperative pain following hindfoot surgery is often severe and can persist for several days. It frequently leads to the use of systemic analgesics, particularly opioids, whose adverse effects are well known. Furthermore, poorly controlled postoperative pain is a recognized independent risk factor for the development of chronic pain.
Ambulatory perineural catheter techniques, already used in our department for hindfoot surgeries, allow for continuous infusion of local anesthetic. They have demonstrated their efficacy in numerous orthopedic surgeries, but data specific to hindfoot surgery remain limited. It therefore seems appropriate to evaluate whether prolonged analgesia via a perineural catheter improves postoperative pain management and promotes functional recovery.
The study is conducted as a practice evaluation audit. It relies on the collection of data from routine care, without any modification to intraoperative care. This methodology allows for an objective evaluation of the benefits of the perineural catheter compared to a single-injection popliteal sciatic block with local anesthetic, while documenting the frequency and nature of complications associated with the technique (leaks, accidental or intentional catheter removal).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional anesthesia | – | Other: Phone contact, Procedure: Regional Anesthesia |
| ambulatory perineural catheter | – | Other: Phone contact, Device: perineural catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University Hospital of Angers
Key inclusion criteria (4 listed)
- Adult patients;
- Patients with an American Society of Anesthesiologists physical status (ASA score) of 1, 2, or 3;
- Patients who have undergone hindfoot surgery;
- Patients capable of completing the questionnaires.
Key exclusion criteria (10 listed)
- Contraindications to regional anesthesia (known hypersensitivity to the local anesthetic, infection at the injection site, uncontrolled neurological condition);
- Emergency surgery
- Cognitive impairment;
- Uncontrolled psychiatric condition;
- Pregnancy or breastfeeding;
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 |
|---|---|---|
| Phone contactAll patients are contacted by phone to assess pain during movement and at rest on each of the first 3 days after surgery, as well as their use of various pain medications | Other | ambulatory perineural catheter, regional anesthesia |
| perineural catheterUse of a perineural catheter for ambulatory analgesia | Device | ambulatory perineural catheter |
| Regional Anesthesiaregional anesthesia | Procedure or surgery | regional anesthesia |
Primary outcome
Pain on movement using a numerical scale from 0 (no pain) to 10 (maximum pain)
Time frame: Day 1 postoperative
Postoperative pain on movement at Day 1. Pain intensity during movement assessed using an 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst possible pain)
10 secondary outcomes
postoperative pain at rest using a numerical scale from 0 (no pain) to 10 (maximum pain)
Time frame: Postoperative Day 0 through Postoperative Day 3
postoperative pain during mobilization using a numerical scale from 0 (no pain) to 10 (maximum pain)
Time frame: From Baseline to Day 3
Postoperative consumption of morphine equivalents in milligrams
Time frame: Postoperative Day 0 through Postoperative Day 3
Daily postoperative consumption of morphine equivalents in milligrams
Time frame: Baseline, Day 1, Day 2 and Day 3
Postoperative use of non-opioid analgesics
Time frame: Postoperative Day 0 through Postoperative Day 3
Daily postoperative use of non-opioid analgesics
Time frame: Baseline, Day 1, Day 2 and Day 3
French Quality of Recovery -15 score (FQoR-15 - from 0 to 150)
Time frame: Postoperative Day 0 through Postoperative Day 2
Proportion of patients experiencing at least one adverse event related to the regional anesthesia technique
Time frame: Postoperative Day 0 through Postoperative Day 3
proportion of patients experiencing at least one postoperative complication following hindfoot surgery
Time frame: Postoperative Day 0 through Postoperative Day 3
length of hospital stay, calculated in whole days
Time frame: Postoperative Day 0 through Postoperative Day 3
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 22 Sep 2026.
Related trials for Hindfoot Surgery
RecruitingObservational study
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Enrolling by invitationPhase 4
Periarticular Injection Versus Popliteal Block
Foot Surgery, Ankle Surgery
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.
Benjamin DUMARTINET principal investigator
University Hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hindfoot Surgery and Analgesia, run by University Hospital, Angers at 1 site 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 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 1 site 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 Benjamin DUMARTINET (241353637 ext. +33, benjamin.dumartinet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on movement using a numerical scale from 0 (no pain) to 10 (maximum pain) (time frame: Day 1 postoperative). 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 22 Sep 2026.