Post-operative pain treatment of patients after major ankle and foot surgery by comparing a nerve block with plain local anesthetic to a newprotracted mixture of local anesthetics.

• Conditions: Post-operative pain after three types of major ankle and hind foot surgery: (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis; MedDRA version: 17.1Level: LLTClassification code 10003396Term: Arthroplasty NOSSystem Organ Class: 100000004865; MedDRA version: 17.1Level: LLTClassification code 10016962Term: Foot arthrodesisSystem Organ Class: 100000004865; MedDRA version: 17.1Level: LLTClassification code 10002540Term: Ankle arthrodesisSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-004207-78-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-19
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Elective ankle or hind foot surgery either (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis
- Age = 18
- ASA I-III
- Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Communication problems or dementia
- Allergies to any medical product used in the study
- Neuropathy of the sciatic or femoral nerve prior to the operation
- Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease
- BMI > 35
- Pregnancy
- Daily use of opioids
- Coagulation disorders
- Infection at the site of injection or systemic infection

Study & Design

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