Trial Outcomes & Findings for Continuous Wound Infiltration After Hallux Valgus Surgery (NCT NCT02182999)
NCT ID: NCT02182999
Last Updated: 2018-08-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
First 48 postoperative hours
Results posted on
2018-08-13
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NaCl 0,9%
n=25 Participants
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.
|
Ropivacaine
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 17.2 • n=25 Participants
|
58.0 years
STANDARD_DEVIATION 13.1 • n=25 Participants
|
55.2 years
STANDARD_DEVIATION 15.4 • n=50 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
40 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
10 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Austria
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
|
BMI
|
24.0 kg/m²
STANDARD_DEVIATION 4.0 • n=25 Participants
|
25.8 kg/m²
STANDARD_DEVIATION 4.2 • n=25 Participants
|
24.9 kg/m²
STANDARD_DEVIATION 4.2 • n=50 Participants
|
PRIMARY outcome
Timeframe: First 48 postoperative hoursThe 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.
Outcome measures
| Measure |
NaCl 0,9%
n=20 Participants
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.
|
Ropivacaine
n=22 Participants
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.
|
|---|---|---|
|
Average Postoperative Numeric Rating Scale (NRS) for Pain
|
2.0 units on a scale
Standard Deviation 0.7
|
1.9 units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: First 48 postoperative hoursThe 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.
Outcome measures
| Measure |
NaCl 0,9%
n=20 Participants
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.
|
Ropivacaine
n=22 Participants
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.
|
|---|---|---|
|
Peak Postoperative Numeric Rating Scale (NRS) for Pain
|
3.9 units on a scale
Standard Deviation 1.7
|
3.5 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 6 weeksThe 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.
Outcome measures
| Measure |
NaCl 0,9%
n=18 Participants
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.
|
Ropivacaine
n=21 Participants
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.
|
|---|---|---|
|
American Orthopaedic Foot and Ankle Society Score (AOFAS)
|
75.8 units on a scale
Standard Deviation 8.9
|
75.7 units on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 6 weeksPatient 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.
Outcome measures
| Measure |
NaCl 0,9%
n=18 Participants
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.
|
Ropivacaine
n=21 Participants
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.
|
|---|---|---|
|
Patient's Overall Satisfaction With Surgery
|
9.1 units on a scale
Standard Deviation 1.3
|
9.0 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 weeksPatient 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.
Outcome measures
| Measure |
NaCl 0,9%
n=18 Participants
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.
|
Ropivacaine
n=21 Participants
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.
|
|---|---|---|
|
Patient's Overall Satisfaction With Pain Management
|
9.3 units on a scale
Standard Deviation 1.2
|
9.0 units on a scale
Standard Deviation 1.2
|
Adverse Events
NaCl 0,9%
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Ropivacaine
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NaCl 0,9%
n=25 participants at risk
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.
|
Ropivacaine
n=25 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Local dysesthesia
|
0.00%
0/25 • 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.
|
4.0%
1/25 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Catheter fixed by a suture
|
4.0%
1/25 • Number of events 1 • 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.
|
0.00%
0/25 • 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.
|
Other adverse events
| Measure |
NaCl 0,9%
n=25 participants at risk
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.
|
Ropivacaine
n=25 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Catheter dislocation
|
12.0%
3/25 • Number of events 3 • 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.
|
8.0%
2/25 • Number of events 2 • 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.
|
Additional Information
Dr. Matthias Braito
Department of Orthopedic Surgery, Medical University of Innsbruck
Phone: 0043 512 504
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place