Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and cost analysis of intravenous fentanyl combined with either local anesthesia infiltration or peroneal nerves block in patients with Hallux Valgus undergoing orthopedic corrective surgery and compared with patients without local anesthetics administration perioperatively.

Official Title
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Comparison of the Efficacy and Cost Analysis of Regional Anesthesia and Intravenous Fentanyl for Postoperative Pain Management in Patients Undergoing Hullax Valgus Surgery

Conditions
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Pain

Intervention / Treatment
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* Procedure: IV fentanyl PCA
* Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCA
* Procedure: Nerve Blocks and post-OP IV fentanyl PCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with American Society of Anesthesiologists physical status I-III aged 20-65 years Requiring local anesthesia and PCA use No severe cardiac or pulmonary diseases BMI <35 kg/m2 Exclusion Criteria: BMI ≧35 kg/m2 age > 65years allergy to opioid or local anesthetics

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV fentanyl PCA<br>The patient receives post-OP IV fentanyl PCA | Procedure: IV fentanyl PCA<br> <br> |
| Active Comparator: post-OP IV fentanyl PCA and local infiltration<br>pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA | Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCA<br> <br> |
| Active Comparator: nerves block and post-OP IV fentanyl PCA<br>pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA | Procedure: Nerve Blocks and post-OP IV fentanyl PCA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| provides adequate pain relief and decreases fentanyl consumption | Patients are subgrouping into groups of post-OP IV fentanyl PCA only, pretreatment of local bupivacaine infiltration and post-OP IV fentanyl PCA, and pretreatment of peroneal nerves block and post-OP IV fentanyl PCA. Resting pain and moving pain scores are measured by the numeric rating scale and classified into none, mild, moderate and severe pain four grades. Pains scale and side effects are recorded at time intervals of post-OP 0 hours, 6 hours, 12 hours, 24 hours, and 36 hours after surgery. | including of surgery and 36 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of side effects and complications | side effects include of intraoperative hypo-tension,dizziness, nausea, and vomiting. | intraoperatively and 36 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCA,Nerve block,Hullax Valgus