The effect of anesthetizing the small nerve to the ankle joint on postoperative pain following major ankle surgery

Phase 1

• Conditions: Post-operative pain after four types of major ankle and hind foot surgery: (1) total ankle arthroplasty, (2) ankle arthrodesis, (3) subtalar arthrodesis or (4) triple arthrodesis; MedDRA version: 19.0Level: LLTClassification code 10003396Term: Arthroplasty NOSSystem Organ Class: 100000004865; MedDRA version: 19.0Level: LLTClassification code 10016962Term: Foot arthrodesisSystem Organ Class: 100000004865; MedDRA version: 19.0Level: LLTClassification code 10002540Term: Ankle arthrodesisSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-000608-27-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-16
• Last Update Posted: 5 June 2017

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 (3) subtalar arthrodesis, (4) triple 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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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
- 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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to conduct a prospective, randomized, controlled, double-blinded trial to compare subsartorial saphenous block with bupivacaine-adrenaline vs. placebo to investigate the effect of a saphenous block as a supplement to a continious sciatic catheter on postoperative pain following major ankle surgery. ;Secondary Objective: Sensory test of the infrapatellar branch as a proxy marker for analgesia of the saphenous nerve. ;Primary end point(s): The frequency of patients who report significant pain at rest (NRS > 3);Timepoint(s) of evaluation of this end point: Pain scores are evaluated 8 times during the 2 hours observation period. <br><br>The observation period starts when the surgery is completed. This time is noted in the electronic patient file = t0<br><br>The test times are:<br>At arrival at the Perioperative Section and at t = 30 min, t = 60 min t = 75 min, t = 90 min, t = 105 min, t = 120 min<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Sensory testing of the infrapatellar branch. The skin is tested in an area from the medial femoral condyle to the midline between the apex of patella and the tibial tuberosity. <br><br>;Timepoint(s) of evaluation of this end point: Sensory testing is conducted when the patient reports significant pain (NRS >3)<br><br>If the patient does not experience any pain during the observation period, sensory testing is conducted at the end of the observation period, t = 120 min