Pain, Sciatic BlockNCT01641419
Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg
A study testing Dexamethasone 4 mg and Dexamethasone 8 mg in people with Pain, Sciatic Block, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. The investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain, Sciatic Block
- What is being tested?
- Dexamethasone 4 mg and Dexamethasone 8 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2014
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-64
- ASA Physcial Status classification 1-3
- Foot and ankle surgery at Ben Taub General Hospital
Who cannot join
- diabetes mellitus
- peripheral neuropathy
- coagulopathy
- allergy to study drugs
- systemic glucocorticoid treatment (for 2 weeks or more) within 6 months of surgery
- chronic opioid use at home
Show all 10Show fewer
- patient inability to properly describe pain to investigators
- pregancy
- prisoners
- patient or surgeon refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg
The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. The investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone.
- Conditions
- Pain, Sciatic Block
- Being tested
- Placebo, Dexamethasone 4 mg, Dexamethasone 8 mg
- Keywords
- Pain, Ropivacaine, sciatic block, dexamethasone
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block
Dexamethasone 4 mgDrug
2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block
Dexamethasone 8 mgDrug
2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Ropivacaine 0.5% plus 2ml of normal saline used for nerve block Receives: Drug: Placebo |
| Dexamethasone 4 mg | Active comparator | Ropivacaine 0.5% plus 2ml of dexamethasone 4 mg used for nerve block Receives: Drug: Dexamethasone 4 mg |
| Dexamethasone 8 mg | Active comparator | Ropivacaine 0.5% plus 2ml of dexamethasone 8 mg used for nerve block Receives: Drug: Dexamethasone 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Duration of analgesia of popliteal fossa sciatic nerve block defined as time of first pain as described by patient minus time of block placement in minutes
Measured: 48 hours
Secondary outcomes (2)
Total pain medication
Total amounts of morphine, fentanyl and hydrocodone/acetaminophen that the patient required for pain control during first 24 hours after surgery.
All patients, regardless of group, will receive a standardized postoperative pain medication regimen which will include hydrocodone/acetaminophen tablets primarily, and morphine/fentanyl as needed.
Measured: 24 hours
Pain scores
Pain score measured of numeric analog scale from 0-10 during first 24 hours measures and 0,1,2,4,8,12, and 24 hours after surgery.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014
Why it stopped: Inability to recruit subjects at our hospital due to change in surgical patient population. Not worth to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Sciatic BlockStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ortiz, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641419
- Sponsor's protocol ID
- H-30398
- Status last verified
- Mar 2015
- First submitted
- 11 Jul 2012
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg
- ClinicalTrials.gov ID
- NCT01641419
- Acronym / sponsor ID
- H-30398
- Conditions
- Pain, Sciatic Block
- Keywords
- Pain, Ropivacaine, sciatic block, dexamethasone
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit subjects at our hospital due to change in surgical patient population. Not worth to continue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jul 2012 (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 is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. The investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboRopivacaine 0.5% plus 2ml of normal saline used for nerve block |
| Dexamethasone 4 mg | Active comparator | Drug: Dexamethasone 4 mgRopivacaine 0.5% plus 2ml of dexamethasone 4 mg used for nerve block |
| Dexamethasone 8 mg | Active comparator | Drug: Dexamethasone 8 mgRopivacaine 0.5% plus 2ml of dexamethasone 8 mg used for nerve block |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-64
- ASA Physcial Status classification 1-3
- Foot and ankle surgery at Ben Taub General Hospital
Key exclusion criteria (10 listed)
- diabetes mellitus
- peripheral neuropathy
- coagulopathy
- allergy to study drugs
- systemic glucocorticoid treatment (for 2 weeks or more) within 6 months of surgery
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 |
|---|---|---|
| Placebo2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block | Drug | Placebo |
| Dexamethasone 4 mg2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block | Drug | Dexamethasone 4 mg |
| Dexamethasone 8 mg2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block | Drug | Dexamethasone 8 mg |
Primary outcome
Duration of analgesia
Time frame: 48 hours
Duration of analgesia of popliteal fossa sciatic nerve block defined as time of first pain as described by patient minus time of block placement in minutes
2 secondary outcomes
Total pain medication
Time frame: 24 hours
Pain scores
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 mg and Dexamethasone 8 mg in people with Pain, Sciatic Block, run by Baylor College of Medicine at 1 site in United States.
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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 17 Mar 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Duration of analgesia (time frame: 48 hours). 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 17 Mar 2015.