Phase 4
N=50
Continuous Wound Infiltration After Hallux Valgus Surgery
Hallux Valgus
Bottom Line
View on ClinicalTrials.gov: NCT02182999 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Aug 2018
Primary outcome: Primary: Average Postoperative Numeric Rating Scale (NRS) for Pain — 2.0; 1.9 units on a scale — p=0.596
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Wound infiltration catheter (Device); NaCl 0.9% (Drug); Ropivacaine 0.2% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University Innsbruck
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Postoperative Numeric Rating Scale (NRS) for Pain |
2.0; 1.9 | 0.596 |
| PRIMARY Peak Postoperative Numeric Rating Scale (NRS) for Pain |
3.9; 3.5 | 0.353 |
| SECONDARY American Orthopaedic Foot and Ankle Society Score (AOFAS) |
75.8; 75.7 | — |
| SECONDARY Patient's Overall Satisfaction With Surgery |
9.1; 9.0 | — |
| SECONDARY Patient's Overall Satisfaction With Pain Management |
9.3; 9.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02182999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.