High Ankle Block in Ankle Fractures

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

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

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Local; Ankle Fractures
• Intervention / Treatment: Drug: 40ml of Ropivacaine 0.5% Injectable Solution; Drug: 40ml of Ringer's Lactate

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine; 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; already outlined in the arm/group description
Placebo Comparator: Ringer's Lactate; Analog to the Experimental Arm, but the same amount of Ringer (40ml) will be plicated instead Ropivacaine	Drug: 40ml of Ringer's Lactate; already outlined in the arm/group description

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Sebastian F Baumbach, MD, Ludwig-Maximilians - University of Munich

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Ankle fracture; Foot block; Perioperative pain management
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2020-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: If requested for a reasonable reason yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No