Continuous Wound Infiltration After Hallux Valgus Surgery

NCT ID: NCT02182999

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-04-30

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).

Conditions

Hallux Valgus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: PLACEBO_COMPARATOR

Wound infiltration catheter

Intervention Type: 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.

NaCl 0.9%

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

Wound infiltration catheter

Intervention Type: 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.

Ropivacaine 0.2%

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

InfiltraLong-Katheter 19G x 420mm, Pajunk; Saline 0.9%; Ropinaest 0.2%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Rainer Biedermann, MD

MD, PD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rainer G. Biedermann, MD

Role: PRINCIPAL_INVESTIGATOR

UK für Orthopädie Innsbruck

Locations

Department of Orthopedic Surgery, Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Countries

Austria

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CWI-HVS

Identifier Type: -

Identifier Source: org_study_id