Foot and Ankle ProceduresPhase 4NCT01975285
Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery
A Phase 4 study testing Dexamethasone and Saline in people with Foot and Ankle Procedures, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Foot and Ankle Procedures
- What is being tested?
- Dexamethasone and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 patients (30 per group) undergoing foot and ankle procedures
- Willingness and ability to sign an informed consent document
- No allergies to anesthetic or analgesic medications
- American Society of Anesthesiologists (ASA)physical status Class I - III
- Aged 18-90 years,either sex
Who cannot join
- Refusal to participate in the study
- Age<18 or> 90 years -
- Contraindications to regional blockage including but not limited to:
- Patient refusal to regional blockade
- Infection at the site of needle insertion
- Systemic infection
- Bleeding diathesis or coagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical center
Los Angeles, California, 90048
About this study
Official title: Prospective Randomized Double Blind Study to Evaluate the Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery.
The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.
- Conditions
- Foot and Ankle Procedures
- Being tested
- Dexamethasone, Saline
- Keywords
- Pain management, Postoperative opioid requirements, Perioperative outcomes, Dexamethasone, Anesthetic adjuvant, Analgesic adjuvant
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc
SalineDrug
Also called placebo
0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Active comparator | Dexamethasone 4mg(1 ml) per 20cc Receives: Drug: Dexamethasone |
| Saline group | Placebo comparator | Saline 1 ml per 20cc Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain
Measured: 3 days
Secondary outcomes (4)
Opioid Consumption
Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)
Measured: 3 days
Length of Analgesia
Time in days and/or hours
Measured: 3 days
Patient Satisfaction With Regional Nerve Block
Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied
Measured: 3 days
Patient Satisfaction With Pain Management
Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Foot and Ankle ProceduresStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975285
- Sponsor's protocol ID
- Pro00032547
- Status last verified
- Apr 2016
- First submitted
- 29 Oct 2013
- Last updated
- 6 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double Blind Study to Evaluate the Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery.
- ClinicalTrials.gov ID
- NCT01975285
- Acronym / sponsor ID
- Pro00032547
- Conditions
- Foot and Ankle Procedures
- Keywords
- Pain management, Postoperative opioid requirements, Perioperative outcomes, Dexamethasone, Anesthetic adjuvant, Analgesic adjuvant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Posted 6 May 2016
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 research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Active comparator | Drug: DexamethasoneDexamethasone 4mg(1 ml) per 20cc |
| Saline group | Placebo comparator | Drug: SalineSaline 1 ml per 20cc |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 patients (30 per group) undergoing foot and ankle procedures
- Willingness and ability to sign an informed consent document
- No allergies to anesthetic or analgesic medications
- American Society of Anesthesiologists (ASA)physical status Class I - III
- Aged 18-90 years,either sex
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- Age<18 or> 90 years -
- Contraindications to regional blockage including but not limited to:
- Patient refusal to regional blockade
- Infection at the site of needle insertion
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 |
|---|---|---|
| DexamethasoneAlso: Decadron0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc | Drug | Dexamethasone group |
| SalineAlso: placebo0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc | Drug | Saline group |
Primary outcome
Postoperative Pain
Time frame: 3 days
Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain
4 secondary outcomes
Opioid Consumption
Time frame: 3 days
Length of Analgesia
Time frame: 3 days
Patient Satisfaction With Regional Nerve Block
Time frame: 3 days
Patient Satisfaction With Pain Management
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Roya Yumul, MD principal investigator
Cedars-Sinai Medical Center
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 Dexamethasone and Saline in people with Foot and Ankle Procedures, run by Cedars-Sinai Medical Center 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 6 May 2016. 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.
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?
Yes. Results are posted in the registry (first posted 6 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Pain (time frame: 3 days). 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 6 May 2016.