Continous wound infiltration after bunion surgery

Phase 1

Conditions: Hallux valgus surgery
MedDRA version: 16.1Level: LLTClassification code 10019095Term: Hallux Valgus correctionSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-005106-64-AT

Lead Sponsor: Medizinische Universität Innsbruck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All patients undergoing a distal metatarsal osteotomy (only Chevron or Scarf) and lateral release of the adductor hallucis muscle with/without concomitant osteotomy of the proximal phalanx of the greater toe (Akin) for idiopathic hallux valgus deformity will be included.
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are 1. hallux valgus surgery other then mentioned above or concomitant other procedures, 2. denial to participate and give informed consent, 3. patients with neurological diseases that affect the sensory-motor function, 4. patients with any short-term (1 month) previous surgery on affected lower extremity, 5. allergies or other comorbidity that prohibits standardized pain regime (renal insufficiency, severe heart or liver impairment, uncontrolled asthma, history of peptic ulcera ) or 6. patients unwilling to undergo surgery without general anesthesia.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to investigate the effect of continous wound infiltration with long-lasting local anesthetics in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome parameters are average pain and peak pain level on the numeric rating scale (NRS) during the first 48 hours after the operation. ;Timepoint(s) of evaluation of this end point: NRS will be evaluated every 4 hours during the first 48 hours after the procedure.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary outcomes include postoperative rescue opioid consumption, clinical outcome (AOFAS forefoot score, ROM of MTP joint of the greater toe), incidence of postoperative complications and patients’ satisfaction with surgery (VRS).;Timepoint(s) of evaluation of this end point: 6 weeks after the procedure.