Local Infiltration Analgesia for Foot Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Procedure: Ankle block

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Nikolaj Kaack Schou, Med.student.; Phone Number: +45 56 63 15 00; Email: niksc@regionsjaelland.dk
• Study Contact Backup: Name: Mathias Maagaard, MD; Phone Number: +45 56 63 15 00; Email: mmaag@regionsjaelland.dk

Study Locations

• Denmark
  • Zealand Region Of Denmark
    • Køge, Zealand Region Of Denmark, Denmark, 4600
      • Recruiting
      • Zealand University Hospital
      • Contact: Mathias Maagaard, MD; Phone Number: +45 56 63 15 00; Email: mmaag@regionsjaelland.dk
      • Contact: Nikolai Kaack Schou, Med.student.; Phone Number: +45 56 63 15 00; Email: niksc@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Local infiltration analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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).	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.	24 hours
Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting.	24 hours

Collaborators and Investigators

• Sponsor: Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Foot surgery; Midfoot surgery; Hindfoot surgery; Forefoot surgery; Ankle surgery; Ankle block; Local infiltration analgesia of the ankle
• Other Study ID Numbers: LIA-COHORTE-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data will be shared upon reasonable request to the coordinating investigator.
• IPD Sharing Time Frame: Data will be made available after primary publication with no time limit.
• IPD Sharing Access Criteria: Reasonable request to the coordinating investigator.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No