Pain, PostoperativePhase 4NCT04304716
Regional Anesthesia for Head and Neck Reconstruction
A Phase 4 study testing Regional Anesthesia in people with Pain, Postoperative, run by University of Florida at 1 site in United States.
Trial summary
By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Regional Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2020to Mar 2021
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
- Subjects undergoing primary reconstruction for both benign and malignant etiology
Who cannot join
- Pregnant women
- Subjects with true allergies to the study drugs, reporting anaphylaxis in the past
- Subjects undergoing reconstruction with more than 1 free flap
- Subjects undergoing secondary reconstructions
- Subjects undergoing surgery for osteonecrosis
- History of enrollment in a pain management program
- Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regional Anesthesia for the Management of Perioperative Pain for Free Flap Reconstruction of the Head and Neck: A Randomized Prospective Trial
By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.
- Conditions
- Pain, Postoperative
- Being tested
- Regional Anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnesthesiaDrug
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Fibular free flap-Block performed | Active comparator | For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed Receives: Drug: Regional Anesthesia |
| Anterolateral thigh free flap-Block performed | Active comparator | Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed Receives: Drug: Regional Anesthesia |
| Radial forearm free flap-Block performed | Active comparator | Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed Receives: Drug: Regional Anesthesia |
| Fibular free flap -Control | No intervention | No additional procedures beyond the normal standard of care will be performed |
| Anterolateral thigh free flap-Control | No intervention | No additional procedures beyond the normal standard of care will be performed |
| Radial forearm free flap-Control | No intervention | No additional procedures beyond the normal standard of care will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Subjects' morphine equivalent dose. Postoperative period commences at extubation.
Measured: 72 hours (3 days) post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: Withdrawn from the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui Fernandes, MD, DMD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304716
- Sponsor's protocol ID
- IRB201903261
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia for the Management of Perioperative Pain for Free Flap Reconstruction of the Head and Neck: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT04304716
- Acronym / sponsor ID
- IRB201903261
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn from the IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 11 Mar 2020 (actual)
- 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.
By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Fibular free flap-Block performed | Active comparator | Drug: Regional AnesthesiaFor subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed |
| Anterolateral thigh free flap-Block performed | Active comparator | Drug: Regional AnesthesiaDescription: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed |
| Radial forearm free flap-Block performed | Active comparator | Drug: Regional AnesthesiaDescription: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed |
| Fibular free flap -Control | No intervention | –No additional procedures beyond the normal standard of care will be performed |
| Anterolateral thigh free flap-Control | No intervention | –No additional procedures beyond the normal standard of care will be performed |
| Radial forearm free flap-Control | No intervention | –No additional procedures beyond the normal standard of care will be performed |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
- Subjects undergoing primary reconstruction for both benign and malignant etiology
Key exclusion criteria (7 listed)
- Pregnant women
- Subjects with true allergies to the study drugs, reporting anaphylaxis in the past
- Subjects undergoing reconstruction with more than 1 free flap
- Subjects undergoing secondary reconstructions
- Subjects undergoing surgery for osteonecrosis
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 |
|---|---|---|
| Regional AnesthesiaBlock performed is an indwelling wound bed or popliteal catheter placed intraoperatively | Drug | Anterolateral thigh free flap-Block performed, Fibular free flap-Block performed, Radial forearm free flap-Block performed |
Primary outcome
Opioid consumption
Time frame: 72 hours (3 days) post-operatively
Subjects' morphine equivalent dose. Postoperative period commences at extubation.
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 18 Mar 2020.
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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.
Rui Fernandes, MD, DMD principal investigator
University of Florida
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 Regional Anesthesia in people with Pain, Postoperative, run by University of Florida 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 2 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: withdrawn, as of the sponsor's last update on 18 Mar 2020. 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 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?
Opioid consumption (time frame: 72 hours (3 days) post-operatively). 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 18 Mar 2020.