Hallux Valgus
Conditions
Keywords
Hallux valgus surgery, wound infiltration, pain
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).
Interventions
DEVICEWound 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.
DRUGNaCl 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.
DRUGRopivacaine 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.
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Postoperative Numeric Rating Scale (NRS) for Pain | 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. |
| Peak Postoperative Numeric Rating Scale (NRS) for Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| American Orthopaedic Foot and Ankle Society Score (AOFAS) | 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. |
| Patient's Overall Satisfaction With Surgery | 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. |
| Patient's Overall Satisfaction With Pain Management | 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. |
Countries
Austria
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | NaCl 0,9% | Ropivacaine | Total |
|---|---|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 17.2 | 58.0 years STANDARD_DEVIATION 13.1 | 55.2 years STANDARD_DEVIATION 15.4 |
| BMI | 24.0 kg/m² STANDARD_DEVIATION 4 | 25.8 kg/m² STANDARD_DEVIATION 4.2 | 24.9 kg/m² STANDARD_DEVIATION 4.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Austria | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 3 / 25 | 2 / 25 |
| serious Total, serious adverse events | 1 / 25 | 1 / 25 |
Outcome results
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.
Time frame: First 48 postoperative hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaCl 0,9% | Average Postoperative Numeric Rating Scale (NRS) for Pain | 2.0 units on a scale | Standard Deviation 0.7 |
| Ropivacaine | Average Postoperative Numeric Rating Scale (NRS) for Pain | 1.9 units on a scale | Standard Deviation 0.8 |
Comparison: A sample size of 17 patients in each group was previously calculated on the basis of a significance level of .05, a power of 80%, an anticipated pooled standard Deviation (SD) of 1.0 of the mean verbal NRS pain level, and a minimal clinically important difference in the mean verbal NRS pain level of 1.0 points between the groups. Anticipating a loss to follow-up, we planned to recruit a total of 50 patients (25 patients each group).p-value: 0.596Wilcoxon (Mann-Whitney)
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.
Time frame: First 48 postoperative hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaCl 0,9% | Peak Postoperative Numeric Rating Scale (NRS) for Pain | 3.9 units on a scale | Standard Deviation 1.7 |
| Ropivacaine | Peak Postoperative Numeric Rating Scale (NRS) for Pain | 3.5 units on a scale | Standard Deviation 2 |
p-value: 0.353Wilcoxon (Mann-Whitney)
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaCl 0,9% | American Orthopaedic Foot and Ankle Society Score (AOFAS) | 75.8 units on a scale | Standard Deviation 8.9 |
| Ropivacaine | American Orthopaedic Foot and Ankle Society Score (AOFAS) | 75.7 units on a scale | Standard Deviation 10.8 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaCl 0,9% | Patient's Overall Satisfaction With Pain Management | 9.3 units on a scale | Standard Deviation 1.2 |
| Ropivacaine | Patient's Overall Satisfaction With Pain Management | 9.0 units on a scale | Standard Deviation 1.2 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaCl 0,9% | Patient's Overall Satisfaction With Surgery | 9.1 units on a scale | Standard Deviation 1.3 |
| Ropivacaine | Patient's Overall Satisfaction With Surgery | 9.0 units on a scale | Standard Deviation 1.3 |