Analgesic efficacy of repetitive nerve blockade after major ankle and hindfoot surgery - A feasibility study

Phase 1

• Conditions: Major ankle and hindfoot surgery; MedDRA version: 20.0Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-004793-95-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-18
• Study Completion: 2020-01-14
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Major ankle and hindfoot surgery
Age older than 18 years
ASA I-III
Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients who can not cooperate with the investigation.
Patients who do not speak and understand Danish
Allergy to drugs used in the study
Diabetis mellitus
Chronic pain (and daily opioid usage)
Pregnancy
Fertile women, who do not use contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of the study is to demonstrate that repetitive nerveblockade with a protracted mixture of local anesthetic can provide postoperative analgesia for 48 h after major ankle and hindfoot surgery;Secondary Objective: Non applicable;Primary end point(s): Cumulated opioid usage 48 h postoperatively;Timepoint(s) of evaluation of this end point: 48 h postoperative

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to first opioid usage because of pain (NRS > 3)<br>NRS score 0, 6, 12, 24 and 48 h postoperatively<br>PONV score 0, 6, 12, 24 and 48 h postoperatively<br>Number of vomiting;Timepoint(s) of evaluation of this end point: 48 h postoperatively