Surgical Procedure, UnspecifiedNCT05385627
Local Infiltration Analgesia for Foot Surgery
An observational study of Surgical Procedure, Unspecified, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Prospective cohort assessing the effects of ankle block (local infiltration analgesia) on duration of analgesia, pain, opioid consumption, and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Ankle block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 12 May 2022to May 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All patients undergoing surgery of the foot or ankle will be assessed for eligibility. We will attempt to include all adult patients receiving local infiltration analgesia of the ankle for pain management following foot or ankle surgery.
Who may be able to join
- Surgery of the foot/ankle
- Intraoperative local infiltration analgesia of the ankle
- Age >= 18 years
Who cannot join
- Inability to read and understand Danish
- Uncooperativeness (judged by investigators)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Køge, Zealand Region of Denmark, 4600
Nikolai Kaack Schou, Med.student., +45 56 63 15 00, niksc@regionsjaelland.dk
Mathias Maagaard, MD, +45 56 63 15 00, mmaag@regionsjaelland.dk
About this study
Prospective cohort assessing the effects of ankle block (local infiltration analgesia) on duration of analgesia, pain, opioid consumption, and patient satisfaction.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Ankle block
- Keywords
- Foot surgery, Midfoot surgery, Hindfoot surgery, Forefoot surgery, Ankle surgery, Ankle block, Local infiltration analgesia of the ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle blockProcedure or surgery
Also called Local infiltration analgesia
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.
| Study group | Role | What they receive |
|---|---|---|
| Ankle block | Any participant receiving an ankle block (local infiltration analgesia). Receives: Procedure: Ankle block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 24 hours
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start12 May 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385627
- Sponsor's protocol ID
- LIA-COHORTE-2022
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon reasonable request to the coordinating investigator.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration Analgesia for Foot Surgery
- ClinicalTrials.gov ID
- NCT05385627
- Acronym / sponsor ID
- LIA-COHORTE-2022
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- Foot surgery, Midfoot surgery, Hindfoot surgery, Forefoot surgery, Ankle surgery, Ankle block, Local infiltration analgesia of the ankle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 23 May 2022 (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.
Prospective cohort assessing the effects of ankle block (local infiltration analgesia) on duration of analgesia, pain, opioid consumption, and patient satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle block | – | Procedure: Ankle blockAny participant receiving an ankle block (local infiltration analgesia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery of the foot or ankle will be assessed for eligibility. We will attempt to include all adult patients receiving local infiltration analgesia of the ankle for pain management following foot or ankle surgery.
Key inclusion criteria (3 listed)
- Surgery of the foot/ankle
- Intraoperative local infiltration analgesia of the ankle
- Age >= 18 years
Key exclusion criteria (2 listed)
- Inability to read and understand Danish
- Uncooperativeness (judged by investigators)
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 |
|---|---|---|
| Ankle blockAlso: Local infiltration analgesiaInjection of local anaesthetics at the level of the ankle blindly (local infiltration analgesia). The dose, volume, and type of local anaesthetic will be registered. | Procedure or surgery | Ankle block |
Primary outcome
Duration of analgesia, measured as time to first pain
Time frame: 24 hours
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.
8 secondary outcomes
Pain in the post-anaesthesia care unit, measured on the Numerical Rating Scale (NRS)
Time frame: 24 hours
Participants with failed block
Time frame: 24 hours
Pain at 6 hours postoperatively, measured on the NRS
Time frame: 6 hours
Pain at 24 hours postoperatively, measured on the NRS
Time frame: 24 hours
Cumulative opioid consumption at 24 hours postoperatively
Time frame: 24 hours
Participant satisfaction related to ankle block
Time frame: 24 hours
Unplanned admission
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon reasonable request to the coordinating investigator.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified, run by Zealand University Hospital at 1 site in Denmark.
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 3 inclusion and 2 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Nikolaj Kaack Schou, Med.student. (+45 56 63 15 00, niksc@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia, measured as time to first pain (time frame: 24 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 23 May 2022.