Local Infiltration Analgesia for Foot Surgery

Surgical Procedure, Unspecified Clinical Trial

Official title:

Local Infiltration Analgesia for Foot Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385627
• Other study ID #: LIA-COHORTE-2022
• Status: Recruiting
• Start date: May 12, 2022
• Est. completion date: May 2024

Study information

• Verified date: May 2022
• Source: Zealand University Hospital
• Contact: Nikolaj Kaack Schou, Med.student.
• Phone: +45 56 63 15 00
• Email: niksc[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

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.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge	Zealand Region Of Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting.	24 hours