Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01960595
• Other study ID #: KMUH-IRB-20120357
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 13, 2013
• Last updated: October 9, 2013
• Start date: August 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2013
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• IV fentanyl PCA

• local bupivacaine infiltration and post-OP IV fentanyl PCA

• Nerve Blocks and post-OP IV fentanyl PCA

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	assessment of cost analysis among groups		surgery period and 36 hours after surgery	No
Primary	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.	including of surgery and 36 hours after surgery	Yes
Secondary	incidence of side effects and complications	side effects include of intraoperative hypo-tension,dizziness, nausea, and vomiting.	intraoperatively and 36 hours after surgery	Yes