Clinical trial NCT04292691: High Ankle Block in Ankle Fractures
Official title: Double-blinded Randomised Controlled Trial (RCT) Comparing a High Ankle Block to Placebo in Patients Treated for Ankle Pathologies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Fractures
Anesthesia, Local
Keywords: Ankle fracture
Foot block
Perioperative pain management
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, randomised control trial
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative morphine milligram equivalent dose during the surgery (skin incision - recovery room)
timeFrame: Begin anaesthesia to begin recovery room; the time will vary between 1 and 4 hours
Secondary outcomes:
measure: Visual Analogue pain Scale (VAS)
timeFrame: 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
measure: Postoperative cumulative morphine milligram equivalent dose
timeFrame: 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.
measure: Rescue medication
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Sebastian F Baumbach, MD
role: PRINCIPAL_INVESTIGATOR
References: