Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

Phase 4UnknownNCT01960595

Kaohsiung Medical University Chung-Ho Memorial Hospital90 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

IV fentanyl PCAPROCEDURE

local bupivacaine infiltration and post-OP IV fentanyl PCAPROCEDURE

Nerve Blocks and post-OP IV fentanyl PCAPROCEDURE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: including of surgery and 36 hours after surgery

Secondary Outcomes

incidence of side effects and complications

side effects include of intraoperative hypo-tension,dizziness, nausea, and vomiting.

Time frame: intraoperatively and 36 hours after surgery

Data from ClinicalTrials.gov

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