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Comparison of continuous infusion versus automated bolus of local anesthetic for postoperative analgesia with popliteal sciatic nerve blockade (nerve catheters) in ambulatory foot surgery.

Phase 1
Conditions
Elective foot surgery under sciatic nerve blockade.
MedDRA version: 19.0Level: PTClassification code 10036276Term: Postoperative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2016-002878-13-BE
Lead Sponsor
Ghent University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

•Elective foot surgery under sciatic nerve blockade
•18–80 years old
•ASA I-III
•Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

•Patient refusal
•Neurologic or neuromuscular disease, diabetic neuropathy
•Anticoagulated patients
•Skin infection at the site of needle insertion
•Inability to understand numeric rating scale (NRS) scores
•Patients with chronic pain disorders
•Intra-articular injection by surgeon
•Allergy to local anesthetics (amides specifically)
•Contraindications for non-steroidal anti-inflammatory drugs

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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