AnesthesiaPhase 4NCT01376960
Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures
A Phase 4 study testing elective forefoot surgery in people with Anesthesia and Forefoot Surgery, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare, for the first time ever, single shot popliteal fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia, Forefoot Surgery
- What is being tested?
- elective forefoot surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective forefoot surgery, including both soft-tissue and osseous procedures
Who cannot join
- Diabetes
- Any form of Peripheral neuropathy
- Known allergy to local anesthesia
- Active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison
The purpose of this study is to compare, for the first time ever, single shot popliteal fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The primary outcome variable for this study is the percentage of patients that convert to general anesthesia following either a single shot popliteal fossa block or ankle block.
H0: There is no difference in the percentage of patients that convert to general anesthesia between single shot popliteal fossa blocks and ankle blocks.
HA: There will be a lower percentage of patients receiving a single shot popliteal fossa block that convert to general anesthesia compared to patients receiving an ankle block.
- Conditions
- Anesthesia, Forefoot Surgery
- Being tested
- elective forefoot surgery
- Keywords
- forefoot surgery, Ankle Block, Popliteal Fossa Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective forefoot surgeryProcedure or surgery
Includes both soft-tissue and osseous procedures.
| Study group | Role | What they receive |
|---|---|---|
| single shot popliteal fossa block | Active comparator | Not described Receives: Procedure: elective forefoot surgery |
| ankle blocks | Active comparator | Not described Receives: Procedure: elective forefoot surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block
Popliteal fossa and ankle blocks are types of anesthesia used during surgery. If these methods are not effective as an anesthetic during surgery the anethesiologist will convert to general anesthesia.
Measured: Participants will be followed for the duration of the surgery, an expected average of 2 hours
Secondary outcomes (4)
Visual Analog Pain Scale (VAS)
Measured: 24 hours postoperatively
Patient Satisfaction
Measured: 48 hours postoperative
Length of Post Anesthesia Care Unit (PACU) stay
Length of PACU stay is calculated from the time the patient is taken from the operative suite to PACU, ie recovery, to the time the patient leaves PACU.
Measured: Up to 6 hours postoperative
Narcotic Use
Measured: Up to 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce E Cohen, MD, Principal investigator, OrthoCarolina, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376960
- Sponsor's protocol ID
- 121809A
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2009
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison
- ClinicalTrials.gov ID
- NCT01376960
- Acronym / sponsor ID
- 121809A
- Conditions
- Anesthesia, Forefoot Surgery
- Keywords
- forefoot surgery, Ankle Block, Popliteal Fossa Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Jun 2011 (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 compare, for the first time ever, single shot popliteal fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The primary outcome variable for this study is the percentage of patients that convert to general anesthesia following either a single shot popliteal fossa block or ankle block.
H0: There is no difference in the percentage of patients that convert to general anesthesia between single shot popliteal fossa blocks and ankle blocks.
HA: There will be a lower percentage of patients receiving a single shot popliteal fossa block that convert to general anesthesia compared to patients receiving an ankle block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single shot popliteal fossa block | Active comparator | Procedure: elective forefoot surgery |
| ankle blocks | Active comparator | Procedure: elective forefoot surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective forefoot surgery, including both soft-tissue and osseous procedures
Key exclusion criteria (4 listed)
- Diabetes
- Any form of Peripheral neuropathy
- Known allergy to local anesthesia
- Active infection
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 |
|---|---|---|
| elective forefoot surgeryIncludes both soft-tissue and osseous procedures. | Procedure or surgery | ankle blocks, single shot popliteal fossa block |
Primary outcome
Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block
Time frame: Participants will be followed for the duration of the surgery, an expected average of 2 hours
Popliteal fossa and ankle blocks are types of anesthesia used during surgery. If these methods are not effective as an anesthetic during surgery the anethesiologist will convert to general anesthesia.
4 secondary outcomes
Visual Analog Pain Scale (VAS)
Time frame: 24 hours postoperatively
Patient Satisfaction
Time frame: 48 hours postoperative
Length of Post Anesthesia Care Unit (PACU) stay
Time frame: Up to 6 hours postoperative
Narcotic Use
Time frame: Up to 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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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.
Bruce E Cohen, MD principal investigator
OrthoCarolina, PA
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 elective forefoot surgery in people with Anesthesia and Forefoot Surgery, run by OrthoCarolina Research Institute, Inc. 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 1 inclusion and 4 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 22 Aug 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block (time frame: Participants will be followed for the duration of the surgery, an expected average of 2 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 22 Aug 2016.