Continuous Wound Infiltration After Hallux Valgus Surgery

Phase 4

Completed

Conditions: Hallux Valgus

Interventions: Device: Wound infiltration catheter
Drug: NaCl 0.9%
Drug: Ropivacaine 0.2%

Registration Number: NCT02182999

Lead Sponsor: Medical University Innsbruck

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0,9%	Wound infiltration catheter	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)
NaCl 0,9%	NaCl 0.9%	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)
Ropivacaine	Wound infiltration catheter	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)
Ropivacaine	Ropivacaine 0.2%	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)

Primary Outcome Measures

Name	Time	Method
Average Postoperative Numeric Rating Scale (NRS) for Pain	First 48 postoperative hours	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. NRS scores for pain were assessed by members of the nursing staff every 4 hours for 48 hours after the procedure (until discharge). Patients were instructed to rate their pain level on a scale from 0 to 10, with 0 meaning "no pain" and 10 indicating "pain as bad as it could be". Average postoperative numeric rating scale (NRS) for pain was calculated for each group (Placebo, Ropivacaine) by adding all postoperative NRS scores of all patients in each group (Placebo, Ropivacaine) to obtain the mean postoperative NRS score.
Peak Postoperative Numeric Rating Scale (NRS) for Pain	First 48 postoperative hours	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. NRS scores for pain were assessed by members of the nursing staff every 4 hours for 48 hours after the procedure (until discharge). Patients were instructed to rate their pain level on a scale from 0 to 10, with 0 meaning "no pain" and 10 indicating "pain as bad as it could be". Peak postoperative numeric rating scale (NRS) for pain was calculated for each group (Placebo, Ropivacaine) by adding the highest recorded NRS score for pain of all patients in each group (Placebo, Ropivacaine) to obtain the mean peak postoperative NRS score.

Secondary Outcome Measures

Name	Time	Method
Patient's Overall Satisfaction With Surgery	6 weeks	Patient satisfaction with surgery was investigated on a numeric rating scale (NRS; scale 0-10) as part of routine examination 6 weeks after the procedure. Higher numbers indicate higher patients satisfaction.
Patient's Overall Satisfaction With Pain Management	6 weeks	Patient satisfaction with pain management was investigated on a numeric rating scale (NRS; scale 0-10) as part of routine examination 6 weeks after the procedure. Higher numbers indicate higher patients satisfaction.
American Orthopaedic Foot and Ankle Society Score (AOFAS)	6 weeks	The American Orthopedic Foot and Ankle Society Score (AOFAS-Score, Forefoot Version) is comprised of nine questions and coveres three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. The scale ranges from 0 to 100, with higher values representing a better outcome.