Skip to content

Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

Comparison of the Efficacy and Cost Analysis of Regional Anesthesia and Intravenous Fentanyl for Postoperative Pain Management in Patients Undergoing Hullax Valgus Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01960595
Enrollment
90
Registered
2013-10-10
Start date
2013-08-31
Completion date
2014-05-31
Last updated
2013-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

PCA,Nerve block,Hullax Valgus

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.

Interventions

PROCEDUREIV fentanyl PCA
PROCEDURElocal bupivacaine infiltration and post-OP IV fentanyl PCA
PROCEDURENerve Blocks and post-OP IV fentanyl PCA

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
provides adequate pain relief and decreases fentanyl consumptionincluding of surgery and 36 hours after surgeryPatients 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

MeasureTime frameDescription
incidence of side effects and complicationsintraoperatively and 36 hours after surgeryside effects include of intraoperative hypo-tension,dizziness, nausea, and vomiting.

Other

MeasureTime frame
assessment of cost analysis among groupssurgery period and 36 hours after surgery

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026