Sciatic NerveDiffuCAddNCT07301476
Evaluation of Local Anesthetic Diffusion to the Sciatic Nerve During Adductor Canal Block
An observational study of Sciatic Nerve and Adductor Canal Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Adductor canal block is an effective analgesic technique for major knee surgery. However, the saphenous nerve block is not sufficient to explain this block's efficiency. It has been shown that adductor canal block can spread to the tibial and fibular nerves through the adductor hiatus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatic Nerve, Adductor Canal Syndrome
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2025to Dec 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: The study population will be all the consecutive patients scheduled for elective knee surgery under general anesthesia in our center and receiving an adductor canal block.
Who may be able to join
- patients over 18 years old scheduled for elective knee surgery under general anesthesia
- in our center
- receiving an adductor canal block
Who cannot join
- patients cognitively impaired,
- patients suffering from peripheral neuropathy at the lower limb,
- patients receiving an IPACK block or surgical knee infiltration to complete the adductor canal block analgesia.
- patients who refused to take part in this study
- pregnant or breastfeeding patients
- patients under guardianship
- imprisoned patients,
- patients without any medical insurance
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
Department of Anesthésia, CHU Raymond Poincaré - APHP
Boulogne-Billancourt, 92100
About this study
Official title: Evaluation of Local Anesthetic Diffusion to the Sciatic Nerve During Adductor Canal Block: an Observational Study
Adductor canal block is an effective analgesic technique for major knee surgery. However, the saphenous nerve block is not sufficient to explain this block's efficiency. It has been shown that adductor canal block can spread to the tibial and fibular nerves through the adductor hiatus. However, this diffusion's frequency has never been measured. The main objective of this study is to assess clinically the frequency of the spread of the adductor canal block to the fibular and tibial nerves.
Read the detailed description
Adductor canal block is an effective analgesic technique for major knee surgery. The PROSPECT group recommends this block in first intention for locoregional anesthesia in total knee arthroplasty. It has been shown to not be inferior to femoral nerve block in this indication.
The adductor canal block targets the saphenous nerve and, through its spread in the adductor canal, the posterior branch of obturator nerve and the vastus medialis nerve. However, these nerves can't fully explain this block's efficiency.
It has been shown that local anesthetic can spread in the adductor canal to the tibial and fibular nerves through the adductor hiatus. However, this spread is inconstant, and no study has evaluated the frequency of this spread yet.
The main objective of this study is to assess the diffusion's frequency of adductor canal block to fibular and tibial nerves through clinical sensorimotor testing.
- Conditions
- Sciatic Nerve, Adductor Canal Syndrome
- Keywords
- Adductor Canal, Sciatic Nerve, Local anesthesia diffusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of local anesthetic's spread to tibial and fibular nerve
The primary outcome is the frequency of local anesthetic's spread to tibial and fibular nerve during an adductor canal block, assessed by sensory and motor testing of these nerve territories.
Sensorimotor testing will be performed at four hours with loco-regional anaesthesia.
Measured: at 4 hours
Secondary outcomes (4)
Frequency of reduction of sensitivity to cold or touch or reduction in MRC score
Frequency of reduction of sensitivity to cold or touch or reduction in MRC score in fibular and tibial nerves territories assessed at one and four hours after the adductor canal block has been performed, as well as reduction of sensitivity to cold or touch in saphenous nerve territory assessed at one and four hours after nerve block.
Measured: at 1 hour and at 4 hours
Spread of the local anesthetic in the popliteal fossa
Qualitative assessment of local anaesthetic spread in the popliteal fossa on ultrasound recording (spread or no spread).
Measured: at baseline
Evaluation of the positive and negative predictive value
Evaluation of the positive and negative predictive value, sensitivity and specificity, and positive and negative likelihood ratio of ultrasound-visualised diffusion to the tibial and fibular nerves as a predictive test for clinical impairment of the sensitivity and motor function of these nerves at 1 hour or 4 hours
Measured: at baseline and 1 hour, 4 hours
Clinical alteration assessement
Clinical alteration of sensibility and motricity will be assessed before the adductor canal block is performed and then at H1 and H4. The ultrasound scan of the popliteal fossa will be performed at the same time as the local anaesthetic is administered.
Measured: at Baseline and at 1 hour and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start10 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic NerveStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romuald Henry, MD, Principal investigator, CHU Raymond Poincaré - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301476
- Sponsor's protocol ID
- APHP250730
- Other IDs
- 2025-A00945-44
- Acronym
- DiffuCAdd
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 24 Dec 2025
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Anesthetic Diffusion to the Sciatic Nerve During Adductor Canal Block: an Observational Study
- ClinicalTrials.gov ID
- NCT07301476
- Acronym / sponsor ID
- DiffuCAdd / APHP250730
- Conditions
- Sciatic Nerve, Adductor Canal Syndrome
- Keywords
- Adductor Canal, Sciatic Nerve, Local anesthesia diffusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Dec 2025 (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.
Adductor canal block is an effective analgesic technique for major knee surgery. However, the saphenous nerve block is not sufficient to explain this block's efficiency. It has been shown that adductor canal block can spread to the tibial and fibular nerves through the adductor hiatus. However, this diffusion's frequency has never been measured. The main objective of this study is to assess clinically the frequency of the spread of the adductor canal block to the fibular and tibial nerves.
Detailed description
Adductor canal block is an effective analgesic technique for major knee surgery. The PROSPECT group recommends this block in first intention for locoregional anesthesia in total knee arthroplasty. It has been shown to not be inferior to femoral nerve block in this indication.
The adductor canal block targets the saphenous nerve and, through its spread in the adductor canal, the posterior branch of obturator nerve and the vastus medialis nerve. However, these nerves can't fully explain this block's efficiency.
It has been shown that local anesthetic can spread in the adductor canal to the tibial and fibular nerves through the adductor hiatus. However, this spread is inconstant, and no study has evaluated the frequency of this spread yet.
The main objective of this study is to assess the diffusion's frequency of adductor canal block to fibular and tibial nerves through clinical sensorimotor testing.
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
- The study population will be all the consecutive patients scheduled for elective knee surgery under general anesthesia in our center and receiving an adductor canal block.
Key inclusion criteria (3 listed)
- patients over 18 years old scheduled for elective knee surgery under general anesthesia
- in our center
- receiving an adductor canal block
Key exclusion criteria (8 listed)
- patients cognitively impaired,
- patients suffering from peripheral neuropathy at the lower limb,
- patients receiving an IPACK block or surgical knee infiltration to complete the adductor canal block analgesia.
- patients who refused to take part in this study
- pregnant or breastfeeding patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of local anesthetic's spread to tibial and fibular nerve
Time frame: at 4 hours
The primary outcome is the frequency of local anesthetic's spread to tibial and fibular nerve during an adductor canal block, assessed by sensory and motor testing of these nerve territories. Sensorimotor testing will be performed at four hours with loco-regional anaesthesia.
4 secondary outcomes
Frequency of reduction of sensitivity to cold or touch or reduction in MRC score
Time frame: at 1 hour and at 4 hours
Spread of the local anesthetic in the popliteal fossa
Time frame: at baseline
Evaluation of the positive and negative predictive value
Time frame: at baseline and 1 hour, 4 hours
Clinical alteration assessement
Time frame: at Baseline and at 1 hour and 4 hours
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 24 Dec 2025.
- 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.
Romuald Henry, MD principal investigator
CHU Raymond Poincaré - APHP
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 Sciatic Nerve and Adductor Canal Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 8 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 24 Dec 2025. 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 Romuald Henry, MD (+ 33 06 72 83 17 51, romuald.henry@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of local anesthetic's spread to tibial and fibular nerve (time frame: at 4 hours). 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 24 Dec 2025.