A Phase 4 interventional study of Mepivacaine and Perifemoral Injection of Local Anesthetic in Tourniquet Hypertension, Intraoperative Hypertension and Total Ankle Arthroplasty, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-05.
Sponsored by Duke University · Phase 4, Interventional, and Supportive care
Among 46 studies in Hypertension by Duke University — 9 open to participants now, 10 under way, none of them phase 3. Hypertension · Duke University.
Among the 46 studies in Hypertension by Duke University, this one is the 30th largest by enrollment of the 37 interventional ones, is the only one that started in 2018, is one of 2 in phase 4, and was the 24th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 31 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →9 of the 46 studies in Hypertension by Duke University are open now, in 2 countries. Each count lists the studies.
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →46 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2018.
Median enrollment 140 across the 37 interventional studies, 1,000 across the 8 observational. Of the 35 that completed or were terminated, 9 (26%) have results posted.
Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
6 of the studies in Hypertension by Duke University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT05459077Duke UniversityAddressing Barriers to Anti-hypertensive Medication Adherence Among PLWH Who Have Achieved Viral Suppression | 2026-12-30 |
| NCT05760898Duke UniversityImproving Hypertension Control in Rheumatoid Arthritis | 2026-12-31 |
| NCT04454203Duke UniversityFemoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension | 2027-02-01 |
| NCT06595251Duke UniversityCommunity Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study | 2027-05-17 |
Among the 46 studies in Hypertension by Duke University, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Drug: Mepivacaine · Procedure: Perifemoral Injection of Local Anesthetic
Injection of salt water (saline) above and beside the femoral artery.
Procedure: Perifemoral Injection of Local Anesthetic · Drug: Saline
An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Also known as: Carbocaine
An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Also known as: Femoral periarterial injection
An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
Also known as: Salt Water placebo
Number of Subjects Experiencing Tourniquet Hypertension
Measuring systolic blood pressure using a cuff, aim to keep \<30mmHg change from baseline
Time frame: Intraoperatively (~3 hours)
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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperatively (~3 hours)
| Milestone | Mepivacaine Block Group | Saline Sham Group |
|---|---|---|
| Started | 15 | 16 |
| Completed | 15 | 15 |
| Not completed | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
Measuring systolic blood pressure using a cuff, aim to keep \<30mmHg change from baseline
| Participants | Mepivacaine Block Group | Saline Sham Group |
|---|---|---|
| Number of Subjects Experiencing Tourniquet Hypertension | 5 | 14 |
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.
| score on a scale | Mepivacaine Block Group | Saline Sham Group |
|---|---|---|
| Pain Scores as Measured by the Numeric Rating Scale (NRS-11) | 1.80 ± 2.86 | 1.07 ± 1.71 |
Amount of opioid pain medication used by patient over a 4 hour period immediately after surgery. Opioids taken are converted to morphine equivalents.
| morphine equivalents | Mepivacaine Block Group | Saline Sham Group |
|---|---|---|
| Amount of Opioid Pain Medications Used by Patient | 10.48 ± 5.77 | 8.19 ± 4.65 |
Amount of esmolol (in mg) used intraoperatively to decrease blood pressure after subject achieved tourniquet hypertension.
| mg | Mepivacaine Block Group | Saline Sham Group |
|---|---|---|
| Amount of Esmolol Used Intraoperatively | 8.00 ± 14.24 | 95.33 ± 107.63 |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mepivacaine Block Group | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Saline Sham Group | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
Subjects who completed the study.
| Age, Categorical(Participants) | Mepivacaine Block Group | Saline Sham Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 7 | 12 |
| >=65 years | 10 | 8 | 18 |
| Age, Continuous(years) | Mepivacaine Block Group | Saline Sham Group | Total |
|---|---|---|---|
| Mean | 60.47 ± 11.84 | 65.67 ± 4.61 | 63.81 ± 9.95 |
| Sex: Female, Male(Participants) | Mepivacaine Block Group | Saline Sham Group | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 13 | 10 | 23 |
| Race (NIH/OMB)(Participants) | Mepivacaine Block Group | Saline Sham Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 14 | 15 | 29 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Mepivacaine Block Group | Saline Sham Group | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
| ASA Status(Participants) | Mepivacaine Block Group | Saline Sham Group | Total |
|---|---|---|---|
| ASA 1 | 2 | 0 | 2 |
| ASA 2 | 6 | 7 | 13 |
| ASA 3 | 7 | 8 | 15 |
| Body Mass Index (BMI)(kg/m^2) | Mepivacaine Block Group | Saline Sham Group | Total |
|---|---|---|---|
| Mean | 31.11 ± 4.63 | 32.64 ± 5.41 | 31.63 ± 5.11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mepivacaine