Continuous Wound Infiltration After Hallux Valgus Surgery

NCT02182999 | Completed Phase 4 Results DMC

• 1 other identifier: CWI-HVS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus

Keywords

Hallux valgus surgery; wound infiltration; pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• American Orthopaedic Foot and Ankle Society Score (AOFAS)

  6 weeks

• Patient's Overall Satisfaction With Surgery

  6 weeks

• Patient's Overall Satisfaction With Pain Management

  6 weeks

Study Arms (2)

NaCl 0,9%

PLACEBO COMPARATOR

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; Drug: NaCl 0.9%

Ropivacaine

ACTIVE COMPARATOR

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; Drug: Ropivacaine 0.2%

Interventions

Wound infiltration catheter DEVICE

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.

Also known as: InfiltraLong-Katheter 19G x 420mm, Pajunk

NaCl 0,9%; Ropivacaine

NaCl 0.9% DRUG

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.

Also known as: Saline 0.9%

NaCl 0,9%

Ropivacaine 0.2% DRUG

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.

Also known as: Ropinaest 0.2%

Ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Department of Orthopedic Surgery, Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Hallux Valgus; Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Primary outcome parameters were only available for 42 out of 50 patients.

Results Point of Contact

• Title: Dr. Matthias Braito
• Organization: Department of Orthopedic Surgery, Medical University of Innsbruck

matthias.braito@gmail.com

0043 512 504

Study Officials

• Rainer G. Biedermann, MD

  UK für Orthopädie Innsbruck

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PD

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 13, 2018
• Results First Posted: August 13, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)