Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

October 9, 2013 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IV fentanyl PCA
The patient receives post-OP IV fentanyl PCA
Procedure: IV fentanyl PCA
ACTIVE_COMPARATOR: post-OP IV fentanyl PCA and local infiltration
pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA
Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCA
ACTIVE_COMPARATOR: nerves block and post-OP IV fentanyl PCA
pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA
Procedure: Nerve Blocks and post-OP IV fentanyl PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
provides adequate pain relief and decreases fentanyl consumption
Time Frame: 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.
including of surgery and 36 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of side effects and complications
Time Frame: intraoperatively and 36 hours after surgery
side effects include of intraoperative hypo-tension,dizziness, nausea, and vomiting.
intraoperatively and 36 hours after surgery

Other Outcome Measures

Outcome Measure
Time Frame
assessment of cost analysis among groups
Time Frame: surgery period and 36 hours after surgery
surgery period and 36 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Director: Peng Ju Huang, MD, PhD., Department of orthopaedic surgery, Kaohsiung Medical University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2014

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

September 13, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (ESTIMATE)

October 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2013

Last Update Submitted That Met QC Criteria

October 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUH-IRB-20120357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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