NCT07078396

Brief Summary

The goal of this observational study is to determine the analgesic duration and analgesic quality of a 1% ropivacaine ankle block in forefoot surgery. Bilateral cases of forefoot surgery, preoperative use of steroids, preexisting lower extremity neuropathy, or failed blocks were not included in this quality improvement program. An ankle block with 1% ropivcaine and patient follow-up is part of the standard practice at Ziekenhuis Oost-Limburg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

June 26, 2025

Last Update Submit

July 17, 2025

Conditions

Forefoot Surgery

Keywords

Ultrasound-guidedAnkle blockRopivacaineForefoot surgeryBlock duration

Outcome Measures

Primary Outcomes (1)

  • Duration sensory block

    Every patient was contacted by phone to assess the duration of analgesia, maximum pain scores within the first 24 hours and patient satisfaction with analgesia on a 10-point visual analog scale (VAS), opioid consumption in the first 24 hours, sleep quality, side effects, and ease of mobilization. If the sensory block had not disappeared at the moment of the survey or if the patient could not be reached, the patient was called again the day after.

    A maximum of 72 hours until return of sensation is expected.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ziekenhuis Oost-Limburg, Genk, Belgium.

You may qualify if:

  • Patients who underwent unilateral elective forefoot surgery under ankle block with 1% ropivacaine between December 2023 and April 2024 at Ziekenhuis Oost-Limburg, Genk, Belgium.

You may not qualify if:

  • Bilateral cases of forefoot surgery
  • Preoperative use of steroids,
  • Preexisting lower extremity neuropathy
  • Failed blocks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, Principle Investigator

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 22, 2025

Study Start

December 1, 2023

Primary Completion

April 24, 2024

Study Completion

April 30, 2024

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)