Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

Phase 4

• Conditions: Pain
• Interventions: Procedure: IV fentanyl PCA; Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCA; Procedure: Nerve Blocks and post-OP IV fentanyl PCA

• Registration Number: NCT01960595
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-08
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-10-09
• Last Update Submitted: 2013-10-09
• Study First Posted: 2013-10-10
• Last Update Posted: 2013-10-10
• Primary Completion: 2014-02
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV fentanyl PCA	IV fentanyl PCA	The patient receives post-OP IV fentanyl PCA
post-OP IV fentanyl PCA and local infiltration	local bupivacaine infiltration and post-OP IV fentanyl PCA	pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA
nerves block and post-OP IV fentanyl PCA	Nerve Blocks and post-OP IV fentanyl PCA	pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA

Primary Outcome Measures

Name	Time	Method
provides adequate pain relief and decreases fentanyl consumption	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 Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan