Continous wound infiltration after bunion surgery

Continous wound infiltration after hallux valgus surgery - CWI-HVS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005106-64-AT

Enrollment

Unknown

Registered

2014-03-07

Start date

2014-03-20

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux valgus surgery MedDRA version: 16.1 Level: LLT Classification code 10019095 Term: Hallux Valgus correction System Organ Class: 100000004865

Interventions

Trade Name: Ropinaest 2 mg/ml - Injektionslösung Pharmaceutical Form: INN or Proposed INN: ROPIVACAINE HYDROCHLORIDE MONOHYDRATE CAS Number: 132112-35-7 Other descriptive name: ROPIVACAINE HYDROCHLOR

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Austria

Contacts

Public ContactChefsekretariat Prof. Krismer

Medizinische Universität Innsbruck

0043512504-22691

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026