MedDataX Logo

Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

NCT ID: NCT01960595

Last Updated: 2013-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

PCA,Nerve block,Hullax Valgus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IV fentanyl PCA

The patient receives post-OP IV fentanyl PCA

Group Type EXPERIMENTAL

IV fentanyl PCA

Intervention Type PROCEDURE

post-OP IV fentanyl PCA and local infiltration

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

Group Type ACTIVE_COMPARATOR

local bupivacaine infiltration and post-OP IV fentanyl PCA

Intervention Type PROCEDURE

nerves block and post-OP IV fentanyl PCA

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

Group Type ACTIVE_COMPARATOR

Nerve Blocks and post-OP IV fentanyl PCA

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IV fentanyl PCA

Intervention Type PROCEDURE

local bupivacaine infiltration and post-OP IV fentanyl PCA

Intervention Type PROCEDURE

Nerve Blocks and post-OP IV fentanyl PCA

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peng Ju Huang, MD, PhD.

Role: STUDY_DIRECTOR

Department of orthopaedic surgery, Kaohsiung Medical University, Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KMUH-IRB-20120357

Identifier Type: -

Identifier Source: org_study_id