Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

Overview

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.

Full Title of Study: “Comparison of the Efficacy and Cost Analysis of Regional Anesthesia and Intravenous Fentanyl for Postoperative Pain Management in Patients Undergoing Hullax Valgus Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2014

Interventions

  • Procedure: IV fentanyl PCA
  • Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCA
  • Procedure: Nerve Blocks and post-OP IV fentanyl PCA

Arms, Groups and Cohorts

  • Experimental: IV fentanyl PCA
    • The patient receives post-OP IV fentanyl PCA
  • Active Comparator: post-OP IV fentanyl PCA and local infiltration
    • pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA
  • Active Comparator: nerves block and post-OP IV fentanyl PCA
    • pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA

Clinical Trial Outcome Measures

Primary Measures

  • provides adequate pain relief and decreases fentanyl consumption
    • Time Frame: including of surgery and 36 hours after surgery
    • 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.

Secondary Measures

  • incidence of side effects and complications
    • Time Frame: intraoperatively and 36 hours after surgery
    • side effects include of intraoperative hypo-tension,dizziness, nausea, and vomiting.

Participating in This Clinical Trial

Inclusion Criteria

1. patients with American Society of Anesthesiologists physical status I-III 2. aged 20-65 years 3. Requiring local anesthesia and PCA use 4. No severe cardiac or pulmonary diseases 5. BMI <35 kg/m2 Exclusion Criteria:

1. BMI ≧35 kg/m2 2. age > 65years 3. allergy to opioid or local anesthetics

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peng Ju Huang, MD, PhD., Study Director, Department of orthopaedic surgery, Kaohsiung Medical University, Taiwan

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