PainPhase 4NCT01960595
Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery
A Phase 4 study testing IV fentanyl PCA, local bupivacaine infiltration and post-OP IV fentanyl PCA and Nerve Blocks and post-OP IV fentanyl PCA in people with Pain, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- IV fentanyl PCA, local bupivacaine infiltration and post-OP IV fentanyl PCA and Nerve Blocks and post-OP IV fentanyl PCA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with American Society of Anesthesiologists physical status I-III
- aged 20-65 years
- Requiring local anesthesia and PCA use
- No severe cardiac or pulmonary diseases
- BMI <35 kg/m2
Who cannot join
- BMI ≧35 kg/m2
- age > 65years
- allergy to opioid or local anesthetics
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807
About this study
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
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.
- Conditions
- Pain
- Being tested
- IV fentanyl PCA, local bupivacaine infiltration and post-OP IV fentanyl PCA, Nerve Blocks and post-OP IV fentanyl PCA
- Keywords
- PCA,Nerve block,Hullax Valgus
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV fentanyl PCAProcedure or surgery
local bupivacaine infiltration and post-OP IV fentanyl PCAProcedure or surgery
Nerve Blocks and post-OP IV fentanyl PCAProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| IV fentanyl PCA | Experimental | The patient receives post-OP IV fentanyl PCA Receives: Procedure: IV fentanyl PCA |
| post-OP IV fentanyl PCA and local infiltration | Active comparator | pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA Receives: Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCA |
| nerves block and post-OP IV fentanyl PCA | Active comparator | pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA Receives: Procedure: Nerve Blocks and post-OP IV fentanyl PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: including of surgery and 36 hours after surgery
Secondary outcomes (1)
incidence of side effects and complications
side effects include of intraoperative hypo-tension,dizziness, nausea, and vomiting.
Measured: intraoperatively and 36 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peng Ju Huang, MD, PhD., Study director, Department of orthopaedic surgery, Kaohsiung Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960595
- Sponsor's protocol ID
- KMUH-IRB-20120357
- Status last verified
- May 2013
- First submitted
- 13 Sep 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01960595
- Acronym / sponsor ID
- KMUH-IRB-20120357
- Conditions
- Pain
- Keywords
- PCA,Nerve block,Hullax Valgus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV fentanyl PCA | Experimental | Procedure: IV fentanyl PCAThe patient receives post-OP IV fentanyl PCA |
| post-OP IV fentanyl PCA and local infiltration | Active comparator | Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCApretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA |
| nerves block and post-OP IV fentanyl PCA | Active comparator | Procedure: Nerve Blocks and post-OP IV fentanyl PCApretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with American Society of Anesthesiologists physical status I-III
- aged 20-65 years
- Requiring local anesthesia and PCA use
- No severe cardiac or pulmonary diseases
- BMI <35 kg/m2
Key exclusion criteria (3 listed)
- BMI ≧35 kg/m2
- age > 65years
- allergy to opioid or local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV fentanyl PCA | Procedure or surgery | IV fentanyl PCA |
| local bupivacaine infiltration and post-OP IV fentanyl PCA | Procedure or surgery | post-OP IV fentanyl PCA and local infiltration |
| Nerve Blocks and post-OP IV fentanyl PCA | Procedure or surgery | nerves block and post-OP IV fentanyl PCA |
Primary outcome
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.
1 secondary outcome
incidence of side effects and complications
Time frame: intraoperatively and 36 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Ju Huang, MD, PhD. study director
Department of orthopaedic surgery, Kaohsiung Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV fentanyl PCA, local bupivacaine infiltration and post-OP IV fentanyl PCA and Nerve Blocks and post-OP IV fentanyl PCA in people with Pain, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
provides adequate pain relief and decreases fentanyl consumption (time frame: including of surgery and 36 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2013.