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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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer G. Biedermann, MD | UK für Orthopädie Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedic Surgery, Medical University of Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
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All patients undergoing a distal metatarsal osteotomy and lateral release with/without concomitant osteotomy of the proximal phalanx of the greater toe for idiopathic hallux valgus deformity at the Department of Orthopedic Surgery, Medical University of Innsbruck, between May 2014 and March 2017 were screened for eligibility to the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) InfiltraLong-Katheter 19G x 420mm, Pajunk: 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%: 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. |
| FG001 | 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) InfiltraLong-Katheter 19G x 420mm, Pajunk: 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: The catheter is connected to the perfusor line filled with ropivacain 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) InfiltraLong-Katheter 19G x 420mm, Pajunk: 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%: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | First 48 postoperative hours |
|
All patients that participated in the study between May 2014 and April 2017 were monitored and followed for 6 weeks.
Adverse Event Reporting Description does not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) InfiltraLong-Katheter 19G x 420mm, Pajunk: 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%: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local dysesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment | One patient complained about severe diffuse local dysesthesia of the foot, which completely resolved after catheter removal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter dislocation | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment | Catheter dislocation occurred in five cases. |
Primary outcome parameters were only available for 42 out of 50 patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthias Braito | Department of Orthopedic Surgery, Medical University of Innsbruck | 0043 512 504 | 81214 | matthias.braito@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2014 | Nov 11, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2014 | Nov 11, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
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| 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. |
|
|
| 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. |
|
|
| 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 |
| BG001 | 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) InfiltraLong-Katheter 19G x 420mm, Pajunk: 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: The catheter is connected to the perfusor line filled with ropivacain 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m² |
|
| OG001 | 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) InfiltraLong-Katheter 19G x 420mm, Pajunk: 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: The catheter is connected to the perfusor line filled with ropivacain 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | First 48 postoperative hours |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
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|
| 0 |
| 25 |
| 1 |
| 25 |
| 3 |
| 25 |
| EG001 | 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) InfiltraLong-Katheter 19G x 420mm, Pajunk: 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: The catheter is connected to the perfusor line filled with ropivacain 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours. | 0 | 25 | 1 | 25 | 2 | 25 |
|
| Catheter fixed by a suture | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment | One revision had to be performed because the wound infiltration catheter was accidentally fixed by a suture. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |