NCT05385627

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 17, 2022

Last Update Submit

May 17, 2022

Conditions

Surgical Procedure, Unspecified

Keywords

Foot surgeryMidfoot surgeryHindfoot surgeryForefoot surgeryAnkle surgeryAnkle blockLocal infiltration analgesia of the ankle

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Secondary Outcomes (8)

  • Pain in the post-anaesthesia care unit, measured on the Numerical Rating Scale (NRS)

    24 hours

  • Participants with failed block

    24 hours

  • Pain at 6 hours postoperatively, measured on the NRS

    6 hours

  • Pain at 24 hours postoperatively, measured on the NRS

    24 hours

  • Cumulative opioid consumption at 24 hours postoperatively

    24 hours

  • +3 more secondary outcomes

Study Arms (1)

Ankle block

Any participant receiving an ankle block (local infiltration analgesia).

Procedure: Ankle block

Interventions

Ankle blockPROCEDURE

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.

Also known as: Local infiltration analgesia
Ankle block

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Inability to read and understand Danish
  • Uncooperativeness (judged by investigators)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Køge, Zealand Region of Denmark, 4600, Denmark

RECRUITING

Central Study Contacts

Nikolaj Kaack Schou, Med.student.

CONTACT

+45 56 63 15 00niksc@regionsjaelland.dk

Mathias Maagaard, MD

CONTACT

+45 56 63 15 00mmaag@regionsjaelland.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 23, 2022

Study Start

May 12, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Individual participant data will be shared upon reasonable request to the coordinating investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

DK(1)