Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

Kaohsiung Medical University

Status and phase: Unknown; Phase 4

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01960595

KMUH-IRB-20120357

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

IV fentanyl PCA

Experimental group

Description:

The patient receives post-OP IV fentanyl PCA

Treatment:

Procedure: IV fentanyl PCA

post-OP IV fentanyl PCA and local infiltration

Active Comparator group

Description:

pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA

Treatment:

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

nerves block and post-OP IV fentanyl PCA

Active Comparator group

Description:

pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA

Treatment:

Procedure: Nerve Blocks and post-OP IV fentanyl PCA