Local Infiltration Analgesia for Foot Surgery

Sponsor
Zealand University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05385627
Collaborator
(none)
100
1
23.7
4.2

Study Details

Study Description

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 Phase
  • Procedure: Ankle block

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Local Infiltration Analgesia for Foot Surgery
Actual Study Start Date :
May 12, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm 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 Names:
  • Local infiltration analgesia
  • Outcome Measures

    Primary Outcome Measures

    1. Duration of analgesia, measured as time to first pain [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) [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 [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 [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 [24 hours]

      Pain at 24 hours postoperatively measured on the NRS as reported by the participant.

    5. Cumulative opioid consumption at 24 hours postoperatively [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 [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 [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 [24 hours]

      Incidence of postoperative nausea and vomiting.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Zealand University Hospital Køge Zealand Region Of Denmark Denmark 4600

    Sponsors and Collaborators

    • Zealand University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zealand University Hospital
    ClinicalTrials.gov Identifier:
    NCT05385627
    Other Study ID Numbers:
    • LIA-COHORTE-2022
    First Posted:
    May 23, 2022
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zealand University Hospital

    Study Results

    No Results Posted as of May 23, 2022