Trials / Completed
CompletedNCT02182999
Continuous Wound Infiltration After Hallux Valgus Surgery
Continuous Wound Infiltration After Hallux Valgus Surgery A Prospective, Randomized, Double-blind and Placebo-controlled Single-center Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Medical University Innsbruck · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Wound infiltration catheter | Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2. |
| DRUG | NaCl 0.9% | The catheter is connected to the perfusor line filled with saline 0.9% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours. |
| DRUG | Ropivacaine 0.2% | The catheter is connected to the perfusor line filled with Ropivacaine 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours. |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2017-04-01
- Completion
- 2017-04-01
- First posted
- 2014-07-08
- Last updated
- 2018-08-13
- Results posted
- 2018-08-13
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT02182999. Inclusion in this directory is not an endorsement.