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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06245460
Other study ID # APHP231771
Secondary ID 2023-A01774-41
Status Recruiting
Phase
First received
Last updated
Start date March 5, 2024
Est. completion date March 2026

Study information

Verified date April 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Romuald Henry, MD
Phone + 33 1 71 16 77 44
Email romuald.henry@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. However this diffusion's frequency has never been measured. The main objective of this study is to assess the frequency of the spread of the adductor canal block to the fibular and tibial nerves assessed by ultrasound observation at the popliteal fossa.


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 ultrasound observation at the popliteal fossa.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients scheduled for elective knee surgery under general anesthesia - in center of Ambroise Paré hospital - 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Department of anesthesia, Ambroise Paré Hospital - APHP Boulogne-Billancourt

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of local anesthetic's spread The primary outcome is the frequency of local anesthetic's spread to tibial and fibular nerve during an adductor canal block, assessed by ultrasound imaging at the popliteal fossa level. The ultrasound images will be recorded and then assessed by two independent anesthesiologists. at baseline
Secondary Frequency of altered sensibility Frequency of altered sensibility and motricity in fibular and tibial nerves territories assessed at one and four hours after the adductor canal block has been performed. at one and four hours
Secondary Correlation between local anesthetic spread and clinical alteration Correlation between local anesthetic spread to tibial and fibular nerves during adductor canal block assessed by ultrasound imaging and clinical alteration of sensibility and motricity in these nerves' territories. at baseline, hour 1 and hour 4th
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