Ankle FracturesNCT04292691
High Ankle Block in Ankle Fractures
A study testing 40ml of Ropivacaine 0.5% Injectable Solution and 40ml of Ringer's Lactate in people with Ankle Fractures and Anesthesia, Local, run by Ludwig-Maximilians - University of Munich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Fractures, Anesthesia, Local
- What is being tested?
- 40ml of Ropivacaine 0.5% Injectable Solution and 40ml of Ringer's Lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Peripheral polyneuropathy
- Peripheral artery disease (PAD) grade IV°
- Dementia
- Depression, anxiety disorders or sleep disorders 18
- Pregnancy
- Denial of study participation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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).
- Conditions
- Ankle Fractures, Anesthesia, Local
- Being tested
- 40ml of Ropivacaine 0.5% Injectable Solution, 40ml of Ringer's Lactate
- Keywords
- Ankle fracture, Foot block, Perioperative pain management
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40ml of Ropivacaine 0.5% Injectable SolutionDrug
already outlined in the arm/group description
40ml of Ringer's LactateDrug
already outlined in the arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | 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) Receives: Drug: 40ml of Ropivacaine 0.5% Injectable Solution |
| Ringer's Lactate | Placebo comparator | Analog to the Experimental Arm, but the same amount of Ringer (40ml) will be plicated instead Ropivacaine Receives: Drug: 40ml of Ringer's Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Begin anaesthesia to begin recovery room; the time will vary between 1 and 4 hours
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, randomised control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich
- Investigators
- Sebastian F Baumbach, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292691
- Sponsor's protocol ID
- 2020-1
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If requested for a reasonable reason yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Randomised Controlled Trial (RCT) Comparing a High Ankle Block to Placebo in Patients Treated for Ankle Pathologies
- ClinicalTrials.gov ID
- NCT04292691
- Acronym / sponsor ID
- 2020-1
- Conditions
- Ankle Fractures, Anesthesia, Local
- Keywords
- Ankle fracture, Foot block, Perioperative pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double blinded, randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: 40ml of Ropivacaine 0.5% Injectable SolutionA 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) |
| Ringer's Lactate | Placebo comparator | Drug: 40ml of Ringer's LactateAnalog to the Experimental Arm, but the same amount of Ringer (40ml) will be plicated instead Ropivacaine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40ml of Ropivacaine 0.5% Injectable Solutionalready outlined in the arm/group description | Drug | Ropivacaine |
| 40ml of Ringer's Lactatealready outlined in the arm/group description | Drug | Ringer's Lactate |
Primary outcome
Cumulative morphine milligram equivalent dose during the surgery (skin incision - recovery room)
Time frame: Begin anaesthesia to begin recovery room; the time will vary between 1 and 4 hours
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)
3 secondary outcomes
Visual Analogue pain Scale (VAS)
Time frame: 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
Time frame: 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 frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: Undecided. If requested for a reasonable reason yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian F Baumbach, MD principal investigator
Ludwig-Maximilians - University of Munich
Questions about this trial
What is this clinical trial studying?
A study testing 40ml of Ropivacaine 0.5% Injectable Solution and 40ml of Ringer's Lactate in people with Ankle Fractures and Anesthesia, Local, run by Ludwig-Maximilians - University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian F Baumbach, MD (0049894400519474, sebastian.baumbach@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative morphine milligram equivalent dose during the surgery (skin incision - recovery room) (time frame: Begin anaesthesia to begin recovery room; the time will vary between 1 and 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.