Clinical trial NCT02182999: Continuous Wound Infiltration After Hallux Valgus Surgery
Official title: Continuous Wound Infiltration After Hallux Valgus Surgery A Prospective, Randomized, Double-blind and Placebo-controlled Single-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hallux Valgus
Keywords: Hallux valgus surgery
wound infiltration
pain
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of continuous wound infiltration with ropivacaine in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control.

Detailed description: The aim of this study is to investigate the effect of continuous wound infiltration with ropivacaine in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control. The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. The secondary outcome parameters included postoperative rescue opioid consumption, clinical outcome (AOFAS forefoot score, ROM of MTP joint of the greater toe), incidence of postoperative complications, and patient satisfaction with surgery on a numeric rating scale (1-10).

Eligibility criteria: Inclusion Criteria:

* All patients undergoing a distal metatarsal osteotomy (only Chevron or Scarf) and lateral release of the adductor halluces muscle with/without concomitant osteotomy of the proximal phalanx of the greater toe (Akin) for idiopathic hallux valgus deformity will be included.

Exclusion Criteria:

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

Primary outcomes:
measure: Average Postoperative Numeric Rating Scale (NRS) for Pain
timeFrame: First 48 postoperative hours
measure: Peak Postoperative Numeric Rating Scale (NRS) for Pain
timeFrame: First 48 postoperative hours
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society Score (AOFAS)
timeFrame: 6 weeks
measure: Patient's Overall Satisfaction With Surgery
timeFrame: 6 weeks
measure: Patient's Overall Satisfaction With Pain Management
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Orthopedic Surgery, Medical University of Innsbruck
state: Tirol
Study officials:
affiliation: UK für Orthopädie Innsbruck
name: Rainer G. Biedermann, MD
role: PRINCIPAL_INVESTIGATOR
References: