Local Infiltration Analgesia for Foot Surgery

Study Overview
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Brief Summary
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Prospective cohort assessing the effects of ankle block (local infiltration analgesia) on duration of analgesia, pain, opioid consumption, and patient satisfaction.

Official Title
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Local Infiltration Analgesia for Foot Surgery

Conditions
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Surgical Procedure, Unspecified

Intervention / Treatment
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* Procedure: Ankle block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgery of the foot/ankle Intraoperative local infiltration analgesia of the ankle Age >= 18 years Exclusion Criteria: Inability to read and understand Danish Uncooperativeness (judged by investigators)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ankle block<br>Any participant receiving an ankle block (local infiltration analgesia). | Procedure: Ankle block<br>* Injection of local anaesthetics at the level of the ankle blindly (local infiltration analgesia). The dose, volume, and type of local anaesthetic will be registered.<br>* Other names: Local infiltration analgesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia, measured as time to first pain | Duration of analgesia measured as time to first pain as reported by the patient. The duration of analgesia is expected to be less than 24 hours. If the duration of analgesia exceeds 24 hours, follow-up will be performed until return of normal sensation is ensured. Duration of analgesia will be set to 24 hours for participants having a duration of analgesia exceeding 24 hours. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in the post-anaesthesia care unit, measured on the Numerical Rating Scale (NRS) | Pain in the post-anaesthesia care unit as reported by the patient on the NRS (0 to 10 points, 0 no pain, 10 worst perceiveable pain). The assessment will be performed just prior to discharge from the post-anaesthesia care unit. | 24 hours | 
| Participants with failed block | Failed block will be defined as participants experiencing pain (NRS > 0) prior to discharge from the post-anaesthesia care unit. | 24 hours | 
| Pain at 6 hours postoperatively, measured on the NRS | Pain at 6 hours postoperatively measured on the NRS as reported by the participant. | 6 hours | 
| Pain at 24 hours postoperatively, measured on the NRS | Pain at 24 hours postoperatively measured on the NRS as reported by the participant. | 24 hours | 
| Cumulative opioid consumption at 24 hours postoperatively | Cumulative opioid consumption at 24 hours postoperatively. Opioid consumption will be converted to intravenous morphine equivalents. Intraoperative opioid use will not be included. | 24 hours | 
| Participant satisfaction related to ankle block | Participants will be asked if they wanted a longer block duration, if they wanted a shorter block duration, and if block duration was adequate (binary outcomes, yes/no). | 24 hours | 
| Unplanned admission | Most participants will be discharged directly from the post-anaesthesia care unit and some will have planned hospital admission following surgery. Unplanned admission will be defined as an admission that was not planned in advance. The reason for admission will be recorded. | 24 hours | 
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foot surgery, Midfoot surgery, Hindfoot surgery, Forefoot surgery, Ankle surgery, Ankle block, Local infiltration analgesia of the ankle