Continuous Wound Infiltration After Hallux Valgus Surgery (CWI-HVS)

Medical University Innsbruck

Status and phase: Completed; Phase 4

Conditions: Hallux Valgus

Treatments: Drug: NaCl 0.9%; Drug: Ropivacaine 0.2%; Device: Wound infiltration catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02182999

CWI-HVS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

NaCl 0,9%

Placebo Comparator group

Description:

Continuous wound infiltration NaCl 0,9% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)

Treatment:

Device: Wound infiltration catheter

Drug: NaCl 0.9%

Ropivacaine

Active Comparator group

Description:

Continuous wound infiltration with Ropivacaine 0,2% 2 ml/h for first 24 postoperative hours by wound infiltration catheter (InfiltraLong-Katheter 19G x 420mm; Pajunk Medizintechnologie GmbH)

Treatment:

Device: Wound infiltration catheter

Drug: Ropivacaine 0.2%