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Local Infiltration Analgesia for Foot Surgery

Local Infiltration Analgesia for Foot Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05385627
Enrollment
100
Registered
2022-05-23
Start date
2022-05-12
Completion date
2024-05-31
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified

Keywords

Foot surgery, Midfoot surgery, Hindfoot surgery, Forefoot surgery, Ankle surgery, Ankle block, Local infiltration analgesia of the ankle

Brief summary

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

Interventions

PROCEDUREAnkle 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.

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Duration of analgesia, measured as time to first pain24 hoursDuration 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

MeasureTime frameDescription
Participants with failed block24 hoursFailed block will be defined as participants experiencing pain (NRS \> 0) prior to discharge from the post-anaesthesia care unit.
Pain at 6 hours postoperatively, measured on the NRS6 hoursPain at 6 hours postoperatively measured on the NRS as reported by the participant.
Pain at 24 hours postoperatively, measured on the NRS24 hoursPain at 24 hours postoperatively measured on the NRS as reported by the participant.
Pain in the post-anaesthesia care unit, measured on the Numerical Rating Scale (NRS)24 hoursPain 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.
Participant satisfaction related to ankle block24 hoursParticipants 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).
Unplanned admission24 hoursMost 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.
Postoperative nausea and vomiting24 hoursIncidence of postoperative nausea and vomiting.
Cumulative opioid consumption at 24 hours postoperatively24 hoursCumulative opioid consumption at 24 hours postoperatively. Opioid consumption will be converted to intravenous morphine equivalents. Intraoperative opioid use will not be included.

Countries

Denmark

Contacts

Primary ContactNikolaj Kaack Schou, Med.student.
niksc@regionsjaelland.dk+45 56 63 15 00
Backup ContactMathias Maagaard, MD
mmaag@regionsjaelland.dk+45 56 63 15 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026