Tourniquet HypertensionPhase 4NCT03390426
Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
A Phase 4 study testing Mepivacaine, Perifemoral Injection of Local Anesthetic and Saline in people with Tourniquet Hypertension and Intraoperative Hypertension, run by Duke University at 1 site in United States.
Trial summary
The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA)… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty
- What is being tested?
- Mepivacaine, Perifemoral Injection of Local Anesthetic and Saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 28 Oct 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
Who cannot join
- ASA 4 or 5
- Diagnosis of chronic pain
- Daily chronic opioid use (over 3 months of continuous opioid use).
- Inability to communicate pain scores or need for analgesia.
- Infection at the site of block placement
- Age under 18 years old or greater than 75 years old
Show all 12Show fewer
- Pregnant women (as determined by standard of care day-of surgery urine bHCG)
- Intolerance/allergy to local anesthetics
- Weight <50 kg
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27713
About this study
The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.
Read the detailed description
The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Efficacy will be determined by analyzing incidence of intraoperative ischemic hypertension, defined as >30% increase in systolic blood pressure, associated with tourniquet inflation times greater than 90 minutes. The study will involve a total of 30 patients (15 in each group) and with a power of 80% to detect a 50% difference. The patients involved in the study will be ASA 1-3 patients who are undergoing either TAA or foot fusion surgeries. Patients will receive standard of care for their anesthesia, which at Duke Hospital includes placement of popliteal and saphenous perineural catheters and a general anesthetic with a laryngeal mask airway. Patients will be randomized to receive femoral peri-arterial injection with either 1.5% mepivacaine with 1:400,000 epinephrine or 0.9% saline which will be performed preoperatively at time of perineural catheter placement. Patients will assume standard risk associated with nerve blocks, including theoretical risk of nerve damage and local anesthetic systemic toxicity. Possible benefits include improved intraoperative hemodynamic stability, decreased intraoperative opioid and antihypertensive medications, and decreased tourniquet associated pain post-operatively.
- Conditions
- Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion
- Being tested
- Mepivacaine, Perifemoral Injection of Local Anesthetic, Saline
- Keywords
- Perifemoral, Tourniquet, Mepivacaine, Tourniquet Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepivacaineDrug
Also called Carbocaine
An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Perifemoral Injection of Local AnestheticProcedure or surgery
Also called Femoral periarterial injection
An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
SalineDrug
Also called Salt Water placebo
An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
| Study group | Role | What they receive |
|---|---|---|
| Mepivacaine Block Group | Experimental | Injection of local anesthetic (mepivacaine) above and beside the femoral artery. Receives: Drug: Mepivacaine; Procedure: Perifemoral Injection of Local Anesthetic |
| Saline Sham Group | Placebo comparator | Injection of salt water (saline) above and beside the femoral artery. Receives: Procedure: Perifemoral Injection of Local Anesthetic; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing Tourniquet Hypertension
Measuring systolic blood pressure using a cuff, aim to keep <30mmHg change from baseline
Measured: Intraoperatively (~3 hours)
Secondary outcomes (3)
Pain Scores as Measured by the Numeric Rating Scale (NRS-11)
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain, 4-6 = Moderate Pain, 7-10 = Severe Pain.
Measured: While in PACU (~1 hour)
Amount of Opioid Pain Medications Used by Patient
Amount of opioid pain medication used by patient over a 4 hour period immediately after surgery. Opioids taken are converted to morphine equivalents.
Measured: Perioperative period (~4 hours)
Amount of Esmolol Used Intraoperatively
Amount of esmolol (in mg) used intraoperatively to decrease blood pressure after subject achieved tourniquet hypertension.
Measured: Intraoperatively (~3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start3 May 2018
- Primary completion27 Oct 2018
- Study completion28 Oct 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourniquet HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William M Bullock, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390426
- Sponsor's protocol ID
- Pro00089161
- Status last verified
- Apr 2021
- First submitted
- 28 Dec 2017
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Publications
Wahal C, Grant SA, Gadsden J, Rambhia MT, Bullock WM. Femoral artery block (FAB) attenuates thigh tourniquet-induced hypertension: a prospective randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Mar;46(3):228-232. doi: 10.1136/rapm-2020-102113. Epub 2021 Jan 11.
PubMed 33431616
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
- ClinicalTrials.gov ID
- NCT03390426
- Acronym / sponsor ID
- Pro00089161
- Conditions
- Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion
- Keywords
- Perifemoral, Tourniquet, Mepivacaine, Tourniquet Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 27 Oct 2018 (actual)
- Study completion
- 28 Oct 2018 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Posted 30 Oct 2019
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 prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.
Detailed description
The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Efficacy will be determined by analyzing incidence of intraoperative ischemic hypertension, defined as >30% increase in systolic blood pressure, associated with tourniquet inflation times greater than 90 minutes. The study will involve a total of 30 patients (15 in each group) and with a power of 80% to detect a 50% difference. The patients involved in the study will be ASA 1-3 patients who are undergoing either TAA or foot fusion surgeries. Patients will receive standard of care for their anesthesia, which at Duke Hospital includes placement of popliteal and saphenous perineural catheters and a general anesthetic with a laryngeal mask airway. Patients will be randomized to receive femoral peri-arterial injection with either 1.5% mepivacaine with 1:400,000 epinephrine or 0.9% saline which will be performed preoperatively at time of perineural catheter placement. Patients will assume standard risk associated with nerve blocks, including theoretical risk of nerve damage and local anesthetic systemic toxicity. Possible benefits include improved intraoperative hemodynamic stability, decreased intraoperative opioid and antihypertensive medications, and decreased tourniquet associated pain post-operatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepivacaine Block Group | Experimental | Drug: Mepivacaine, Procedure: Perifemoral Injection of Local AnestheticInjection of local anesthetic (mepivacaine) above and beside the femoral artery. |
| Saline Sham Group | Placebo comparator | Procedure: Perifemoral Injection of Local Anesthetic, Drug: SalineInjection of salt water (saline) above and beside the femoral artery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
Key exclusion criteria (12 listed)
- ASA 4 or 5
- Diagnosis of chronic pain
- Daily chronic opioid use (over 3 months of continuous opioid use).
- Inability to communicate pain scores or need for analgesia.
- Infection at the site of block placement
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 |
|---|---|---|
| MepivacaineAlso: CarbocaineAn ultrasound guided injection of mepivacaine superomedially to the femoral artery. | Drug | Mepivacaine Block Group |
| Perifemoral Injection of Local AnestheticAlso: Femoral periarterial injectionAn ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively. | Procedure or surgery | Mepivacaine Block Group, Saline Sham Group |
| SalineAlso: Salt Water placeboAn ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water. | Drug | Saline Sham Group |
Primary outcome
Number of Subjects Experiencing Tourniquet Hypertension
Time frame: Intraoperatively (~3 hours)
Measuring systolic blood pressure using a cuff, aim to keep <30mmHg change from baseline
3 secondary outcomes
Pain Scores as Measured by the Numeric Rating Scale (NRS-11)
Time frame: While in PACU (~1 hour)
Amount of Opioid Pain Medications Used by Patient
Time frame: Perioperative period (~4 hours)
Amount of Esmolol Used Intraoperatively
Time frame: Intraoperatively (~3 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33431616Wahal C, Grant SA, Gadsden J, Rambhia MT, Bullock WM. Femoral artery block (FAB) attenuates thigh tourniquet-induced hypertension: a prospective randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Mar;46(3):228-232. doi: 10.1136/rapm-2020-102113. Epub 2021 Jan 11.
- Individual participant dataSharing planned: No. Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Related trials for Tourniquet Hypertension
Recruiting
Gradual Versus Intermittent Release of Tourniquet Effect on MAP in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries
Hemodynamics
Recruiting
A Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery
Tourniquet Hypertension
RecruitingPhase 4
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Tourniquet Hypertension, Intraoperative Hypertension
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.
William M Bullock principal investigator
Assistant Professor
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 Mepivacaine, Perifemoral Injection of Local Anesthetic and Saline in people with Tourniquet Hypertension and Intraoperative Hypertension, run by Duke University 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 12 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 5 May 2021. 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 30 Oct 2019). 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?
Number of Subjects Experiencing Tourniquet Hypertension (time frame: Intraoperatively (~3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03390426, which also lists 1 linked publication.
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 5 May 2021.