Overview

This trial is active, not recruiting.

Condition pain
Treatments iv fentanyl pca, local bupivacaine infiltration and post-op iv fentanyl pca, nerve blocks and post-op iv fentanyl pca
Phase phase 4
Sponsor Kaohsiung Medical University Chung-Ho Memorial Hospital
Start date August 2013
End date February 2014
Trial size 90 participants
Trial identifier NCT01960595, KMUH-IRB-20120357

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The patient receives post-OP IV fentanyl PCA
iv fentanyl pca
(Active Comparator)
pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA
local bupivacaine infiltration and post-op iv fentanyl pca
(Active Comparator)
pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA
nerve blocks and post-op iv fentanyl pca

Primary Outcomes

Measure
provides adequate pain relief and decreases fentanyl consumption
time frame: including of surgery and 36 hours after surgery

Secondary Outcomes

Measure
incidence of side effects and complications
time frame: intraoperatively and 36 hours after surgery

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

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

Additional Information

Official title Comparison of the Efficacy and Cost Analysis of Regional Anesthesia and Intravenous Fentanyl for Postoperative Pain Management in Patients Undergoing Hullax Valgus Surgery
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Kaohsiung Medical University Chung-Ho Memorial Hospital.