Postoperative PainNCT02104778
Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine
A study testing Dexamethasone and Epinephrine in people with Postoperative Pain, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
The aim of the present study is to test that adding dexamethasone or epinephrine significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the magnitude of the effect differs among dexamethasone and epinehrine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone and Epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Jul 2016
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I and II
- patients undergoing elective hallux valgus repair
Who cannot join
- patients receiving chronic analgesic therapy
- diabetes
- peripheral neuropathies
- psychiatric disorders
- hypersensitivity to amide local anesthetics
- renal disorders
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Daegu, 705-035
Duckhee Lee, M.D., 82-53-620-3365, apsj0718@naver.com
Sangjin Park, M.D.
About this study
Official title: Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine in Ankle and Foot Surgery
The aim of the present study is to test that adding dexamethasone or epinephrine significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the magnitude of the effect differs among dexamethasone and epinehrine.
Read the detailed description
In a double-blinded trial utilizing single-injection sciatic nerve block, patients are randomly assigned to one of three groups: control: 0.5% ropivacaine adding normal saline; epinephrine: 0.5% ropivacaine adding epinephrine; dexamethasone: 0.5% ropivacaine adding dexamethasone. We assess time to first analgesic request after post-anaesthesia care unit discharge.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Epinephrine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
In dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
EpinephrineDrug
Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block. Receives: Drug: Dexamethasone |
| Control | Placebo comparator | Normal saline 1 ml is added to 0.5% ropivacaine 20 ml for sciatic nerve block. |
| epinephrine | Experimental | Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block. Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first analgesic request after postanesthetic care unit discharge
A blinded observer interview patients at arrival in postanesthetic care unit, 6 hour, 24 hour, 48 hour, 72 hour after operation.
Measured: from arrival in postanesthetic care unit to 72 hours after operation
Secondary outcomes (1)
time of recovery of motor and sensory functions on the operated foot
The time of recovery of motor (ability to move the ankle) and sensory (recovery of normal pinprick sensation) functions on the operated foot is recorded by the blinded observer at arrival in postanesthetic care unit, 6 hour, 24 hour, 48 hour, 72 hour after operation.
Measured: from arrival in postanesthetic care unit to 72 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangjin Park, Yeungnam University College of Medicine
- Investigators
- Sangjin Park, M.D., Principal investigator, Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104778
- Sponsor's protocol ID
- apsj20140401
- Status last verified
- Jul 2015
- First submitted
- 1 Apr 2014
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine in Ankle and Foot Surgery
- ClinicalTrials.gov ID
- NCT02104778
- Acronym / sponsor ID
- apsj20140401
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 4 Apr 2014 (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 aim of the present study is to test that adding dexamethasone or epinephrine significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the magnitude of the effect differs among dexamethasone and epinehrine.
Detailed description
In a double-blinded trial utilizing single-injection sciatic nerve block, patients are randomly assigned to one of three groups: control: 0.5% ropivacaine adding normal saline; epinephrine: 0.5% ropivacaine adding epinephrine; dexamethasone: 0.5% ropivacaine adding dexamethasone. We assess time to first analgesic request after post-anaesthesia care unit discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneDexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block. |
| Control | Placebo comparator | –Normal saline 1 ml is added to 0.5% ropivacaine 20 ml for sciatic nerve block. |
| epinephrine | Experimental | Drug: EpinephrineEpinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I and II
- patients undergoing elective hallux valgus repair
Key exclusion criteria (6 listed)
- patients receiving chronic analgesic therapy
- diabetes
- peripheral neuropathies
- psychiatric disorders
- hypersensitivity to amide 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 |
|---|---|---|
| DexamethasoneIn dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block. | Drug | Dexamethasone |
| EpinephrineEpinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block | Drug | epinephrine |
Primary outcome
time to first analgesic request after postanesthetic care unit discharge
Time frame: from arrival in postanesthetic care unit to 72 hours after operation
A blinded observer interview patients at arrival in postanesthetic care unit, 6 hour, 24 hour, 48 hour, 72 hour after operation.
1 secondary outcome
time of recovery of motor and sensory functions on the operated foot
Time frame: from arrival in postanesthetic care unit to 72 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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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.
Sangjin Park, M.D. principal investigator
Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Epinephrine in people with Postoperative Pain, run by Yeungnam University College of Medicine at 1 site in South Korea.
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 2 inclusion and 6 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 16 Jul 2015. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Sangjin Park, M.D. (82-53-620-3366, apsj0718@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first analgesic request after postanesthetic care unit discharge (time frame: from arrival in postanesthetic care unit to 72 hours after operation). 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 16 Jul 2015.