- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07301476
Evaluation of Local Anesthetic Diffusion to the Sciatic Nerve During Adductor Canal Block (DiffuCAdd)
Evaluation of Local Anesthetic Diffusion to the Sciatic Nerve During Adductor Canal Block: an Observational Study
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Romuald Henry, MD
- Phone Number: + 33 06 72 83 17 51
- Email: romuald.henry@aphp.fr
Study Locations
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Boulogne-Billancourt, France, 92100
- Recruiting
- Department of Anesthésia, CHU Raymond Poincaré - APHP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients over 18 years old scheduled for elective knee surgery under general anesthesia
- in our center
- receiving an adductor canal block
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of local anesthetic's spread to tibial and fibular nerve
Time Frame: at 4 hours
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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. |
at 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of reduction of sensitivity to cold or touch or reduction in MRC score
Time Frame: at 1 hour and at 4 hours
|
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.
|
at 1 hour and at 4 hours
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Spread of the local anesthetic in the popliteal fossa
Time Frame: at baseline
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Qualitative assessment of local anaesthetic spread in the popliteal fossa on ultrasound recording (spread or no spread).
|
at baseline
|
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Evaluation of the positive and negative predictive value
Time Frame: at baseline and 1 hour, 4 hours
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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
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at baseline and 1 hour, 4 hours
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Clinical alteration assessement
Time Frame: at Baseline and at 1 hour and 4 hours
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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.
|
at Baseline and at 1 hour and 4 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Romuald Henry, MD, CHU Raymond Poincaré - APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APHP250730
- 2025-A00945-44 (Registry Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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