Popliteal Nerve BlockPhase 3NCT04872322
Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery
A Phase 3 study testing Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.25% Injectable Solution and Percocet Pill in people with Popliteal Nerve Block and Foot Surgery, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
With the increasing rise of outpatient surgery in orthopaedic procedures, the management of immediate postoperative pain has been a major topic investigated, with the use of a peripheral nerve block in combination with general anesthesia being a commonly accepted method. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Popliteal Nerve Block, Foot Surgery, Ankle Surgery
- What is being tested?
- Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.25% Injectable Solution and Percocet Pill
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2017to 31 Dec 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing foot and ankle surgeries under the care of Dr. Steven Raikin with continuous popliteal blocks at Riverview Surgical Center will be considered for enrollment.
Who cannot join
- Patients who present with a) known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type,
- Existing use of narcotics,
- Pregnant women,
- Individuals under the age of 18
- Procedures involving any other forms of anesthesia other than general anesthesia with a continuous popliteal nerve block.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Randomized Study of the Effect of Initial Ropivacaine Dosage During Continuous Popliteal Nerve Blocks on Rebound Pain in Foot and Ankle Surgery
With the increasing rise of outpatient surgery in orthopaedic procedures, the management of immediate postoperative pain has been a major topic investigated, with the use of a peripheral nerve block in combination with general anesthesia being a commonly accepted method. Foot and ankle procedures, which offer the choice of several anesthetic techniques, have increasingly been performed with this method predominantly through the combination of general anesthesia with a single-injection popliteal nerve block to reduce the substantial acute postoperative pain that often requires large opioid intake within the post-anesthesia care unit (PACU). However, as a single-injection peripheral nerve block resolves off shortly following surgery, major postoperative pain, termed "rebound pain", can also arise, and has the potential to be even greater than that of patients who do not receive any peripheral nerve block with general anesthesia.
The purpose of this study is to evaluate the contribution of ropivacaine concentration (0.5% versus 0.25%) of the initial bolus in continuous popliteal nerve blocks toward the rebound pain phenomena, or the quantifiable difference in pain experienced during the initial time after block resolution, in foot and ankle surgeries.
- Conditions
- Popliteal Nerve Block, Foot Surgery, Ankle Surgery
- Being tested
- Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.25% Injectable Solution, Percocet Pill, Norco Pill, Foot/Ankle Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5% Injectable SolutionDrug
Participants will receive the nerve block preoperatively using 0.5% ropivacaine
Ropivacaine 0.25% Injectable SolutionDrug
Participants will receive the nerve block preoperatively using 0.25% ropivacaine
Percocet PillDrug
After surgery participants will be given a prescription for Percocet to be taken as needed for pain
Norco PillDrug
After surgery participants will be given a prescription for Norco to be taken as needed for pain
Foot/Ankle SurgeryProcedure or surgery
Participant will undergo foot or ankle surgery and receive a popliteal nerve block
| Study group | Role | What they receive |
|---|---|---|
| Standard Popliteal Nerve Block | Active comparator | Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine. Receives: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.25% Injectable Solution; Drug: Percocet Pill; Drug: Norco Pill; Procedure: Foot/Ankle Surgery |
| Partial Popliteal Nerve Block | Active comparator | Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery Receives: Drug: Ropivacaine 0.25% Injectable Solution; Drug: Percocet Pill; Drug: Norco Pill; Procedure: Foot/Ankle Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Participants Satisfaction with pain control will be measured using the Visual Analog Scale for Pain (VAS)
Measured: 7 days
Postoperative Opioid Usage
For each group, participants will be asked to record their postoperative pain medication usage daily
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start31 Aug 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal Nerve BlockStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872322
- Sponsor's protocol ID
- SRAI17D.481
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 4 May 2021
- 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the Effect of Initial Ropivacaine Dosage During Continuous Popliteal Nerve Blocks on Rebound Pain in Foot and Ankle Surgery
- ClinicalTrials.gov ID
- NCT04872322
- Acronym / sponsor ID
- SRAI17D.481
- Conditions
- Popliteal Nerve Block, Foot Surgery, Ankle Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 May 2021 (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.
With the increasing rise of outpatient surgery in orthopaedic procedures, the management of immediate postoperative pain has been a major topic investigated, with the use of a peripheral nerve block in combination with general anesthesia being a commonly accepted method. Foot and ankle procedures, which offer the choice of several anesthetic techniques, have increasingly been performed with this method predominantly through the combination of general anesthesia with a single-injection popliteal nerve block to reduce the substantial acute postoperative pain that often requires large opioid intake within the post-anesthesia care unit (PACU). However, as a single-injection peripheral nerve block resolves off shortly following surgery, major postoperative pain, termed "rebound pain", can also arise, and has the potential to be even greater than that of patients who do not receive any peripheral nerve block with general anesthesia.
The purpose of this study is to evaluate the contribution of ropivacaine concentration (0.5% versus 0.25%) of the initial bolus in continuous popliteal nerve blocks toward the rebound pain phenomena, or the quantifiable difference in pain experienced during the initial time after block resolution, in foot and ankle surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Popliteal Nerve Block | Active comparator | Drug: Ropivacaine 0.5% Injectable Solution, Drug: Ropivacaine 0.25% Injectable Solution, Drug: Percocet Pill, Drug: Norco Pill, Procedure: Foot/Ankle SurgeryParticipants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine. |
| Partial Popliteal Nerve Block | Active comparator | Drug: Ropivacaine 0.25% Injectable Solution, Drug: Percocet Pill, Drug: Norco Pill, Procedure: Foot/Ankle SurgeryParticipants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing foot and ankle surgeries under the care of Dr. Steven Raikin with continuous popliteal blocks at Riverview Surgical Center will be considered for enrollment.
Key exclusion criteria (5 listed)
- Patients who present with a) known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type,
- Existing use of narcotics,
- Pregnant women,
- Individuals under the age of 18
- Procedures involving any other forms of anesthesia other than general anesthesia with a continuous popliteal nerve block.
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 |
|---|---|---|
| Ropivacaine 0.5% Injectable SolutionParticipants will receive the nerve block preoperatively using 0.5% ropivacaine | Drug | Standard Popliteal Nerve Block |
| Ropivacaine 0.25% Injectable SolutionParticipants will receive the nerve block preoperatively using 0.25% ropivacaine | Drug | Partial Popliteal Nerve Block, Standard Popliteal Nerve Block |
| Percocet PillAfter surgery participants will be given a prescription for Percocet to be taken as needed for pain | Drug | Partial Popliteal Nerve Block, Standard Popliteal Nerve Block |
| Norco PillAfter surgery participants will be given a prescription for Norco to be taken as needed for pain | Drug | Partial Popliteal Nerve Block, Standard Popliteal Nerve Block |
| Foot/Ankle SurgeryParticipant will undergo foot or ankle surgery and receive a popliteal nerve block | Procedure or surgery | Partial Popliteal Nerve Block, Standard Popliteal Nerve Block |
Primary outcome
Postoperative Pain
Time frame: 7 days
Participants Satisfaction with pain control will be measured using the Visual Analog Scale for Pain (VAS)
Postoperative Opioid Usage
Time frame: 7 days
For each group, participants will be asked to record their postoperative pain medication usage daily
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.25% Injectable Solution and Percocet Pill in people with Popliteal Nerve Block and Foot Surgery, run by Rothman Institute Orthopaedics 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 5 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: status not confirmed, as of the sponsor's last update on 4 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Postoperative Pain (time frame: 7 days). The study lists 2 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 4 May 2021.