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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182999
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Rainer Biedermann, MD, 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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Device: Wound infiltration catheter Drug: NaCl 0.9% Drug: Ropivacaine 0.2% Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Wound Infiltration After Hallux Valgus Surgery A Prospective, Randomized, Double-blind and Placebo-controlled Single-center Trial
Actual Study Start Date : May 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Ropinaest 0.2%




Primary Outcome Measures :
  1. Average Postoperative Numeric Rating Scale (NRS) for Pain [ Time Frame: 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.

  2. Peak Postoperative Numeric Rating Scale (NRS) for Pain [ Time Frame: 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 :
  1. American Orthopaedic Foot and Ankle Society Score (AOFAS) [ Time Frame: 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.

  2. Patient's Overall Satisfaction With Surgery [ Time Frame: 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.

  3. Patient's Overall Satisfaction With Pain Management [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182999


Locations
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Austria
Department of Orthopedic Surgery, Medical University of Innsbruck
Innsbruck, Tirol, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Rainer G. Biedermann, MD UK für Orthopädie Innsbruck
  Study Documents (Full-Text)

Documents provided by Rainer Biedermann, MD, Medical University Innsbruck:
Informed Consent Form  [PDF] February 28, 2014


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Responsible Party: Rainer Biedermann, MD, MD, PD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02182999    
Other Study ID Numbers: CWI-HVS
First Posted: July 8, 2014    Key Record Dates
Results First Posted: August 13, 2018
Last Update Posted: August 13, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rainer Biedermann, MD, Medical University Innsbruck:
Hallux valgus surgery
wound infiltration
pain
Additional relevant MeSH terms:
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Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents