Foot SurgeryPhase 4PvPNCT04575688
Periarticular Injection Versus Popliteal Block
A Phase 4 study testing Exparel and Bupivicaine in people with Foot Surgery and Ankle Surgery, run by Campbell Clinic at 1 site in United States.
Trial summary
This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Surgery, Ankle Surgery
- What is being tested?
- Exparel and Bupivicaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2021to 28 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle or hindfoot osteotomy or ankle fracture repair
- Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)
- 18-80 years of age
- ASA I-III with medical clearances as needed
- Fluent ub verbal and written English
- Willing and able to comply with study instruction and commit to all follow-up visits for theduration of the study
- Willing and able to provide written consent
Who cannot join
- Diagnosed with chronic pain syndrome
- History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents
- Injury associated with workers' compensation
- Surgery to be performed at a hospital
- Diagnosed with peripheral neuropathy
- Hbg A1C is > 7 mg/dl in diabetic patients only
- Long term (chronic) preoperative narcotic usage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures
This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.
Read the detailed description
This is a prospective, randomized, controlled research study of two perioperative standards of care for managing post operative pain. The first standard of care procedure is the periarticular injection; the second is the popiteal block.
- Conditions
- Foot Surgery, Ankle Surgery
- Being tested
- Exparel, Bupivicaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Also called Periarticular Injection
Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
BupivicaineDrug
Also called Peripheral Nerve Injection
Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
| Study group | Role | What they receive |
|---|---|---|
| Periarticular Injection | Active comparator | Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a periarticular injection by the surgeon using 10 milliliters of Exparel mixed with 10 milliliters of bupivicaine 0.5 percent at the end of the procedure. Receives: Drug: Exparel |
| Popliteal Block | Active comparator | Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a popliteal block by the anesthesiologist using 30 milliliters of bupivicaine 0.5 percent in the pre-operative area, prior to surgery, using an ultrasound machine for guidance. Receives: Drug: Bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative hour 3
Evidence of motor block
Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?"
Measured: Postoperative hour 3
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative hour 6
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative hour 12
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative hour 24
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative hour 36
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative hour 48
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative hour 72
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative week 2
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative week 4-6
Visual Analog Score
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Measured: Postoperative week 12
Secondary outcomes (13)
Document pain medication prescribed immediately after surgery
Pain medication prescribed immediately after the surgery will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed immediately after surgery, to include opiate name, dose, and number of pills prescribed.
Measured: Immediately after surgery
Satisfaction with pain control: survey question
Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.
Measured: Postoperative week 2
Neuralgia symptoms: survey question
Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.
Measured: Postoperative week two
Pill count
Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."
Measured: Postoperative week 2
Document pain medication prescribed at postoperative week 2
Pain medication prescribed at postoperative week 2 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 2, to include opiate name, dose, and number of pills prescribed.
Measured: Postoperative week 2
Satisfaction with pain control: survey question
Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.
Measured: Postoperative week 6
Neuralgia symptoms: survey question
Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.
Measured: Postoperative week 6
Pill count
Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."
Measured: Postoperative week 6
Document pain medication prescribed at postoperative week 6
Pain medication prescribed at postoperative week 6 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 6, to include opiate name, dose, and number of pills prescribed.
Measured: Postoperative week 6
Satisfaction with pain control: survey question
Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.
Measured: Postoperative week 12
Neuralgia symptoms: survey question
Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.
Measured: Postoperative week 12
Pill count
Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."
Measured: Postoperative week 12
Document pain medication prescribed at postoperative week 12
Pain medication prescribed at postoperative week 12 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 12, to include opiate name, dose, and number of pills prescribed.
Measured: Postoperative week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start13 Jul 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot SurgeryStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garnett A Murphy, MD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575688
- Sponsor's protocol ID
- 19-06453-FB
- Acronym
- PvP
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures
- ClinicalTrials.gov ID
- NCT04575688
- Acronym / sponsor ID
- PvP / 19-06453-FB
- Conditions
- Foot Surgery, Ankle Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 5 Oct 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.
This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.
Detailed description
This is a prospective, randomized, controlled research study of two perioperative standards of care for managing post operative pain. The first standard of care procedure is the periarticular injection; the second is the popiteal block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periarticular Injection | Active comparator | Drug: ExparelSubjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a periarticular injection by the surgeon using 10 milliliters of Exparel mixed with 10 milliliters of bupivicaine 0.5 percent at the end of the procedure. |
| Popliteal Block | Active comparator | Drug: BupivicaineSubjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a popliteal block by the anesthesiologist using 30 milliliters of bupivicaine 0.5 percent in the pre-operative area, prior to surgery, using an ultrasound machine for guidance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ankle or hindfoot osteotomy or ankle fracture repair
- Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)
- 18-80 years of age
- ASA I-III with medical clearances as needed
- Fluent ub verbal and written English
Key exclusion criteria (7 listed)
- Diagnosed with chronic pain syndrome
- History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents
- Injury associated with workers' compensation
- Surgery to be performed at a hospital
- Diagnosed with peripheral neuropathy
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 |
|---|---|---|
| ExparelAlso: Periarticular InjectionExparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair. | Drug | Periarticular Injection |
| BupivicaineAlso: Peripheral Nerve InjectionBupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair. | Drug | Popliteal Block |
Primary outcome
Visual Analog Score
Time frame: Postoperative hour 3
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Evidence of motor block
Time frame: Postoperative hour 3
Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?"
Visual Analog Score
Time frame: Postoperative hour 6
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Visual Analog Score
Time frame: Postoperative hour 12
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Visual Analog Score
Time frame: Postoperative hour 24
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Visual Analog Score
Time frame: Postoperative hour 36
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Visual Analog Score
Time frame: Postoperative hour 48
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Visual Analog Score
Time frame: Postoperative hour 72
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Visual Analog Score
Time frame: Postoperative week 2
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Visual Analog Score
Time frame: Postoperative week 4-6
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Visual Analog Score
Time frame: Postoperative week 12
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
13 secondary outcomes
Document pain medication prescribed immediately after surgery
Time frame: Immediately after surgery
Satisfaction with pain control: survey question
Time frame: Postoperative week 2
Neuralgia symptoms: survey question
Time frame: Postoperative week two
Pill count
Time frame: Postoperative week 2
Document pain medication prescribed at postoperative week 2
Time frame: Postoperative week 2
Satisfaction with pain control: survey question
Time frame: Postoperative week 6
Neuralgia symptoms: survey question
Time frame: Postoperative week 6
Pill count
Time frame: Postoperative week 6
Document pain medication prescribed at postoperative week 6
Time frame: Postoperative week 6
Satisfaction with pain control: survey question
Time frame: Postoperative week 12
Neuralgia symptoms: survey question
Time frame: Postoperative week 12
Pill count
Time frame: Postoperative week 12
Document pain medication prescribed at postoperative week 12
Time frame: Postoperative week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Garnett A Murphy, MD principal investigator
Campbell Clinic
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 Exparel and Bupivicaine in people with Foot Surgery and Ankle Surgery, run by Campbell Clinic 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 7 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: enrolling by invitation, as of the sponsor's last update on 24 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Score (time frame: Postoperative hour 3). The study lists 11 primary outcomes in all. 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 24 Dec 2025.