Local Infiltration Analgesia for Foot Surgery

• Conditions: Surgical Procedure, Unspecified
• Interventions: Procedure: Ankle block

• Registration Number: NCT05385627
• Lead Sponsor: Zealand University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-12
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Last Update Submitted: 2022-05-17
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ankle block	Ankle block	Any participant receiving an ankle block (local infiltration analgesia).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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).
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.
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.
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.
Postoperative nausea and vomiting	24 hours	Incidence of postoperative nausea and vomiting.

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Køge, Zealand Region Of Denmark, Denmark