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Local Infiltration Analgesia for Foot Surgery

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ClinicalTrials.gov Identifier: NCT05385627
Recruitment Status : Recruiting
First Posted : May 23, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Study Description
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Brief Summary:
Prospective cohort assessing the effects of ankle block (local infiltration analgesia) on duration of analgesia, pain, opioid consumption, and patient satisfaction.

Condition or disease Intervention/treatment
Surgical Procedure, Unspecified Procedure: Ankle block

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Local Infiltration Analgesia for Foot Surgery
Actual Study Start Date : May 12, 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Ankle block
Any participant receiving an ankle block (local infiltration analgesia).
 Procedure: Ankle block
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.
Other Name: Local infiltration analgesia


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain in the post-anaesthesia care unit, measured on the Numerical Rating Scale (NRS) [ Time Frame: 24 hours ]
    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.

  2. Participants with failed block [ Time Frame: 24 hours ]
    Failed block will be defined as participants experiencing pain (NRS > 0) prior to discharge from the post-anaesthesia care unit.

  3. Pain at 6 hours postoperatively, measured on the NRS [ Time Frame: 6 hours ]
    Pain at 6 hours postoperatively measured on the NRS as reported by the participant.

  4. Pain at 24 hours postoperatively, measured on the NRS [ Time Frame: 24 hours ]
    Pain at 24 hours postoperatively measured on the NRS as reported by the participant.

  5. Cumulative opioid consumption at 24 hours postoperatively [ Time Frame: 24 hours ]
    Cumulative opioid consumption at 24 hours postoperatively. Opioid consumption will be converted to intravenous morphine equivalents. Intraoperative opioid use will not be included.

  6. Participant satisfaction related to ankle block [ Time Frame: 24 hours ]
    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).

  7. Unplanned admission [ Time Frame: 24 hours ]
    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.

  8. Postoperative nausea and vomiting [ Time Frame: 24 hours ]
    Incidence of postoperative nausea and vomiting.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Surgery of the foot/ankle
  • Intraoperative local infiltration analgesia of the ankle
  • Age >= 18 years

Exclusion Criteria:

  • Inability to read and understand Danish
  • Uncooperativeness (judged by investigators)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05385627


Contacts
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Contact: Nikolaj Kaack Schou, Med.student. +45 56 63 15 00 niksc@regionsjaelland.dk
Contact: Mathias Maagaard, MD +45 56 63 15 00 mmaag@regionsjaelland.dk

Locations
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Denmark
Zealand University Hospital Recruiting
Køge, Zealand Region Of Denmark, Denmark, 4600
Contact: Nikolai Kaack Schou, Med.student.    +45 56 63 15 00    niksc@regionsjaelland.dk   
Contact: Mathias Maagaard, MD    +45 56 63 15 00    mmaag@regionsjaelland.dk   
Sponsors and Collaborators
Zealand University Hospital
More Information
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT05385627    
Other Study ID Numbers: LIA-COHORTE-2022
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be shared upon reasonable request to the coordinating investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be made available after primary publication with no time limit.
Access Criteria: Reasonable request to the coordinating investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
Foot surgery
Midfoot surgery
Hindfoot surgery
Forefoot surgery
 Ankle surgery
Ankle block
Local infiltration analgesia of the ankle