High Ankle Block in Ankle Fractures

Study Overview
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Brief Summary
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The aim of the herein presented double-blinded is to compare the effectiveness of the high foot block against placebo infiltration in simple, uni- and bimalleolar ankle fractures. Included will be all adult patients (>18a) treated surgically at our department. The standard peri-operative procedure at our clinic will no be altered but the additional high ankle block. The intraoperative opioid requirement, the Visual Analogue Scale for Pain (VAS) and the postoperative opioid requirement will be assessed and compared between the two groups

Detailed Description
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Ankle fractures were among the most common injuries of the lower extremity. Peri-operative, multimodal pain therapy is of great importance in the surgical treatment of those injuries. Whereas simple (uni- and bimalleolar) ankle fractures are covered peri-operatively by oral pain medication and Piritramid-PCA (PCA=Patient-controlled analgesia), complex, trimalleolar fractures usually receive additional regional pain catheters (femoralis blockade and ischiadicus blockade). Regional pain catheters have the major downside of motor paresis and are therefore critically discussed. Various studies have explored new techniques for perioperative pain therapy. An established procedure in midfoot and forefoot surgery is the foot block. It can be inserted at different heights around the ankle joint. However, the effectiveness of the high foot block has not yet been investigated for ankle fractures. The aim of the herein presented double-blinded is to compare the effectiveness of the high foot block against placebo infiltration in simple, uni- and bimalleolar ankle fractures. All patients who are operated on in our department due to a uni- or bimalleolar ankle fracture, who are over 18 years of age and have no serious pre-existing conditions or contraindications to local anaesthesia (LA) are eligible for inclusion. The perioperative procedure does not change to the current treatment standard at the University Hospital Munich - Ludwig Maximilians University (LMU) except for randomization for high foot block or placebo. Both the anesthesia and the postoperative pain therapy correspond to the current treatment standard and are the same for both groups. The intraoperative opioid requirement, the VAS and the postoperative opioid requirement will be assessed. The data is collected using the RedCap database (#19-177), which has already been reviewed by the ethics committee. The evaluation will be performed using SPSS 25.0 (IBM).

Official Title
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Double-blinded Randomised Controlled Trial (RCT) Comparing a High Ankle Block to Placebo in Patients Treated for Ankle Pathologies

Conditions
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Ankle Fractures, Anesthesia, Local

Intervention / Treatment
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* Drug: 40ml of Ropivacaine 0.5% Injectable Solution
* Drug: 40ml of Ringer's Lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >17 years and <71 years Glomerular filtration rate (GFR) > 60 American Society of Anaesthesiologists physical status classification system (ASA) < 4 Independently mobile without aids before an accident Informed consent Uni- or bimalleolar (medial and lateral malleolus) ankle fractures requiring surgery Exclusion Criteria: Age <18 years; >70 years GFR < 60 ASA > 3 Trimalleolar fractures or fractures necessitating open reduction and internal fixation (ORIF) of the posterior malleolus Not able to walk without aids (stick, rollator, etc.) Allergy to local anesthetics or drugs of the postOP pain regime Peripheral polyneuropathy Peripheral artery disease (PAD) grade IV° Dementia Depression, anxiety disorders or sleep disorders 18 Pregnancy Denial of study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded, randomised control trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>A cumulative amount of approx. 40ml ropivacaine 0.5% (≙400mg (2x200mg) ropivacaine) is applied immediately before surgery. They are applied in a ring wall 10 cm cranially of the tip of the medial and lateral malleolus (N. peroneus superficialis (N. cutaneus dorsalis medius et intermedius, N. saphenus, N. suralis), as well as sonographically controlled (N. peroneus profundus and N. suralis) | Drug: 40ml of Ropivacaine 0.5% Injectable Solution<br>* already outlined in the arm/group description<br>|
| Placebo Comparator: Ringer's Lactate<br>Analog to the Experimental Arm, but the same amount of Ringer (40ml) will be plicated instead Ropivacaine | Drug: 40ml of Ringer's Lactate<br>* already outlined in the arm/group description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative morphine milligram equivalent dose during the surgery (skin incision - recovery room) | The morphine equivalent doses will be calculated based on the morphines given throughout the surgery: Begin anaesthesia to begin recovery room Cumulative morphine milligram equivalent dose during the surgery (skin incision - recovery room) | Begin anaesthesia to begin recovery room; the time will vary between 1 and 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue pain Scale (VAS) | Postoperative pain measured on a 0-100 Visual Analogue pain Scale (VAS) with 0 meaning no pain and 100 most sever pain imaginable | Will be collected at arrival at the recovery room and then 2 hours, 4 hours, 6 hours thereafter. For the further in-house duration,the VAS will be collected at 08:00 and 21:00 o'clock every day for further two days | 
| Postoperative cumulative morphine milligram equivalent dose | The cumulative morphine milligram equivalent dose will be calculated from the Piritramid PCA. The PCA saves each application date and amount. This data will be gathered at the time, when the patient does not rely on the PCA any more. The Piritramid PCA will be only used in-house. | The Piritramid PCA will be started in the recovery room and stay with the patient until she or he does not rely on it any more. Usually, the patients keep the PCA for the first two postoperative days. | 
| Rescue medication | Time to first rescue medication. Rescue medication is defined as the first Piritramid application through the PCA system by the patient. | The Piritramid-PCA is provided as long as requested by the patient during his in-house stay. We expect the patient to request rescue medication within the first 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle fracture, Foot block, Perioperative pain management