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

Continuous Wound Infiltration After Hallux Valgus Surgery A Prospective, Randomized, Double-blind and Placebo-controlled Single-center Trial

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.

Study Overview

• Status: Completed
• Conditions: Hallux Valgus
• Intervention / Treatment: Device: Wound infiltration catheter; Drug: NaCl 0.9%; Drug: Ropivacaine 0.2%

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Department of Orthopedic Surgery, Medical University of Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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)	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.; Other Names: InfiltraLong-Katheter 19G x 420mm, Pajunk; 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.; Other Names: Saline 0.9%
Active Comparator: Ropivacaine; 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)	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.; Other Names: InfiltraLong-Katheter 19G x 420mm, Pajunk; 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.; Other Names: Ropinaest 0.2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Postoperative Numeric Rating Scale (NRS) for Pain	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.	First 48 postoperative hours
Peak Postoperative Numeric Rating Scale (NRS) for Pain	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.	First 48 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Orthopaedic Foot and Ankle Society Score (AOFAS)	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.	6 weeks
Patient's Overall Satisfaction With Surgery	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.	6 weeks
Patient's Overall Satisfaction With Pain Management	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.	6 weeks

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Rainer G. Biedermann, MD, UK für Orthopädie Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: pain; wound infiltration; Hallux valgus surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CWI-HVS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No