Health TrialsbyHealthPanel

The 5-in-2 Ankle Block for Outpatient Foot Surgery: the FIT Block Study

ConditionFoot Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.

Popliteal sciatic nerve block is widely used but at risk of falling due to prolonged motor blockade and foot drop. Ankle block is recognized as a good regional anesthesia technique but requires five skin punctures.

FIT block might be a good alternative, aiming to provide an optimal anesthetic block, good postoperative analgesia without motor blockade (calf muscles) and necessitating only two skin punctures.

The purpose of this study is to describe the technique and the efficacy and safety of the FIT block for outpatient foot surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged over 18 years old

Scheduled for outpatient foot surgery and undergoing a FIT-block as regional anesthesia

Disqualifiers

Severe coagulopathy

Peripheral neuropathy or chronic pain syndrome

Infection or injury at the needle entry points

Allergy or contraindications to study drugs

Trial population

Patients with FIT-Block for outpatient foot surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Five-in-two ankle block

    Other intervention

    The FIT block is a new approach for regional anesthetic block of the ankle. We use an optimized ultrasound guided approach for the FIT Block, based on optimal nerve anatomical locations. A one puncture proximal approach for the fibular nerves is used, while maintaining the benefit of preserved extrinsic motricity. Another one puncture approaches the sural nerve laterally, after the block of the tibial nerve during the same puncture and then the subcutaneous infiltration of the saphenous nerve. An anatomical proof of concept study has been done before the exploratory clinical study. These approaches permit a surgical anesthetic block for foot surgery using 2 punctures (instead of 5) with a single patient's body position, compatible with sedation.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Complete motor and sensory blocks

Complete motor and sensory blocks required for surgery under exclusive regional anesthesia by 5-in-2 ankle block

Time frame
From 30 min after regional anesthesia to discharge from the operating room

Secondary outcomes

1

Duration of the 5-in-2 ankle block

Delay before the resolution of motor and sensory blocks

Time frame
From 30 min after regional anesthesia to 24 hours after surgery
2

Pain intensity

Measured by Visual Analogue Scale (VAS) at rest and during movement from 0 (no pain) to 10 (worst pain).

Time frame
From leaving the operating room to 24 hours after surgery
3

Morphine sulfate consumption

The total morphine sulfate consumption from the operating room discharge to 24 hours after surgery

Time frame
From leaving the operating room to 24 hours after surgery
4

Patient satisfaction

Assessed by EVAN-LR questionnaire (Evaluation du Vécu de l'Anesthésie LocoRégionale) from 0 (worst satisfaction) to 10 (best satisfaction).

Time frame
The day after surgery (24 hours)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: