Sickle Cell DiseasePhase 1RESCUEDNCT01256281
Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency Department: Phase I
A Phase 1 study testing Femoral Nerve Block in people with Sickle Cell Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The hypothesis of this study is: Femoral nerve blocks can feasibly be performed on patients with Sickle Cell Disease and painful crisis in the Emergency Department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Femoral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2013
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- Documented SCD: HbSS, HbSC, HbSβ0Thal, HbSβ+Thal
- Rapid onset of acute pain consistent with VOC
- Pain in at least one lower extremity
- Pain requiring admission to the hospital
- Cognitive ability to report pain on a 0-10 NRS
Who cannot join
- Primary admitting diagnosis other than VOC
- Contraindication to femoral nerve block
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: RESCUED: Phase I: Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency
The hypothesis of this study is:
Femoral nerve blocks can feasibly be performed on patients with Sickle Cell Disease and painful crisis in the Emergency Department.
Read the detailed description
Phase I: The feasibility cohort will consist of a convenience sample. Dr. Glassberg will wear the SCD-FNB pager at all times and will enroll patients whenever logistically possible.
Participants: ED patients aged >18 who require admission for vasoocclusive pain involving the lower extremities. Vasoocclusive pain is defined as acute onset of corporeal pain, not controlled by oral analgesics, in a patient with SCD with no other apparent cause.
Description of Standard Analgesic Practices: All patients enrolled in the study will receive standardized care based on ED computer order sets designed by Drs. Shi \& Glassberg and other members of the Hematology and Emergency departments (appendix E). Based on NIH52 and American Pain Society53 guidelines and current clinical evidence, these protocols were established to ensure delivery of optimal opiate therapy for patients with VOC pain. Initially, the patient will receive IV doses of opiates at the EP's discretion, followed by initiation of morphine or hydro-morphone PCA (patient controlled analgesia). PCA will continue when patient is moved to the inpatient floor, where care will also be guided by standardized order sets.
Description of the FNB Intervention: Throughout the FNB procedure, the patient will have continuous EKG, NIBP and O2 saturation monitoring. With the patient in the supine position, the leg to be blocked will be slightly abducted and externally rotated. The femoral crease and the area approximately 3 inches above and below is prepped and draped in usual sterile fashion. 1-2 ml of local anesthetic will be injected at the probable site of insertion. A sterile ultrasound probe is used to identify the femoral vessels and the femoral nerve, which usually lies 1-2 cm lateral to the artery. The femoral nerve sheath is then entered under direct visualization. Before injection, the syringe will be gently aspirated with negative blood return to ensure that the needle is not intravascular. 20mL of 0.25% bupivicaine will then be given, and deposition of anesthetic will be visualized within the nerve sheath. Intermittent aspiration and continuous ultrasound visualization during anesthetic delivery will ensure that the tip of the needle has not migrated. Injection will also be stopped and the needle repositioned if the patient complains of new or worsening pain, as this may indicate intraneural injection. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
Outcomes: This study is not exploring the efficacy of the intervention, nor is the intervention being compared to a control. Phase one is simply to verify that FNB is a feasible procedure to be performed in the ER in this population.
- Conditions
- Sickle Cell Disease
- Being tested
- Femoral Nerve Block
- Keywords
- Sickle Cell Disease, Pain, Vasoocclusion, Nerve Block, Regional Anesthesia
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve BlockProcedure or surgery
Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Block | Experimental | Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked. Receives: Procedure: Femoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score in Legs (0-10)
Pain score in legs at 2-4 hours after intervention will be the primary outcome.
Data analysis not done.
Measured: 2-4 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: lack of resources
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 Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey D Glassberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256281
- Sponsor's protocol ID
- 10-0934
- Acronym
- RESCUED
- Status last verified
- Apr 2015
- First submitted
- 7 Dec 2010
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESCUED: Phase I: Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency
- ClinicalTrials.gov ID
- NCT01256281
- Acronym / sponsor ID
- RESCUED / 10-0934
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Pain, Vasoocclusion, Nerve Block, Regional Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of resources
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Posted 23 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is:
Femoral nerve blocks can feasibly be performed on patients with Sickle Cell Disease and painful crisis in the Emergency Department.
Detailed description
Phase I: The feasibility cohort will consist of a convenience sample. Dr. Glassberg will wear the SCD-FNB pager at all times and will enroll patients whenever logistically possible.
Participants: ED patients aged >18 who require admission for vasoocclusive pain involving the lower extremities. Vasoocclusive pain is defined as acute onset of corporeal pain, not controlled by oral analgesics, in a patient with SCD with no other apparent cause.
Description of Standard Analgesic Practices: All patients enrolled in the study will receive standardized care based on ED computer order sets designed by Drs. Shi \& Glassberg and other members of the Hematology and Emergency departments (appendix E). Based on NIH52 and American Pain Society53 guidelines and current clinical evidence, these protocols were established to ensure delivery of optimal opiate therapy for patients with VOC pain. Initially, the patient will receive IV doses of opiates at the EP's discretion, followed by initiation of morphine or hydro-morphone PCA (patient controlled analgesia). PCA will continue when patient is moved to the inpatient floor, where care will also be guided by standardized order sets.
Description of the FNB Intervention: Throughout the FNB procedure, the patient will have continuous EKG, NIBP and O2 saturation monitoring. With the patient in the supine position, the leg to be blocked will be slightly abducted and externally rotated. The femoral crease and the area approximately 3 inches above and below is prepped and draped in usual sterile fashion. 1-2 ml of local anesthetic will be injected at the probable site of insertion. A sterile ultrasound probe is used to identify the femoral vessels and the femoral nerve, which usually lies 1-2 cm lateral to the artery. The femoral nerve sheath is then entered under direct visualization. Before injection, the syringe will be gently aspirated with negative blood return to ensure that the needle is not intravascular. 20mL of 0.25% bupivicaine will then be given, and deposition of anesthetic will be visualized within the nerve sheath. Intermittent aspiration and continuous ultrasound visualization during anesthetic delivery will ensure that the tip of the needle has not migrated. Injection will also be stopped and the needle repositioned if the patient complains of new or worsening pain, as this may indicate intraneural injection. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
Outcomes: This study is not exploring the efficacy of the intervention, nor is the intervention being compared to a control. Phase one is simply to verify that FNB is a feasible procedure to be performed in the ER in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block | Experimental | Procedure: Femoral Nerve BlockPatients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or above
- Documented SCD: HbSS, HbSC, HbSβ0Thal, HbSβ+Thal
- Rapid onset of acute pain consistent with VOC
- Pain in at least one lower extremity
- Pain requiring admission to the hospital
Key exclusion criteria (3 listed)
- Primary admitting diagnosis other than VOC
- Contraindication to femoral nerve block
- Pregnant
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 |
|---|---|---|
| Femoral Nerve BlockPatients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked. | Procedure or surgery | Femoral Nerve Block |
Primary outcome
Pain Score in Legs (0-10)
Time frame: 2-4 hours after intervention
Pain score in legs at 2-4 hours after intervention will be the primary outcome. Data analysis not done.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey D Glassberg, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Femoral Nerve Block in people with Sickle Cell Disease, run by Icahn School of Medicine at Mount Sinai 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 6 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: stopped early, as of the sponsor's last update on 23 Apr 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 23 Apr 2015). 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?
Pain Score in Legs (0-10) (time frame: 2-4 hours after intervention). 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 23 Apr 2015.