Single Shot Exparel vs Catheters in Lower Extremity Trauma

October 24, 2025 updated by: George Washington University

Single-Shot Exparel Versus Catheters for Lower Extremity Orthopedic Trauma Patients

This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. The comparison will be done in patients who receive preoperative adductor and sciatic nerve blocks prior to orthopedic surgery for traumatic lower extremity injury. The patients' pain will then be monitored for up to 72 hours after injection, measuring every 12 hours after injection until the 72-hour mark. Opioid consumption (measured in morphine milligram equivalents) will also be tracked over this time period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The use of Exparel has been widely criticized over the past few years with regard to its efficacy compared to perineural catheters and whether or not it truly lasts 72 hours, as is often advertised. However, it is still used in many centers for the proposed increased duration of action and ease of use compared to indwelling catheters, which require a greater degree of monitoring and follow-up for removal. Various studies conducted have looked at the efficacy of Exparel and have found no superiority over nerve blocks with other local anesthetic agents. However, nerve blocks with catheters have never been directly compared to exparel injections for pain control. As such, the goal of this study is to elucidate whether there truly is a difference between the two. In this study, the study team will compare preoperative adductor and sciatic nerve blocks with exparel versus catheters in orthopedic surgery patients who present with a traumatic lower extremity injury. Exparel has been documented to increase the duration of a nerve block by up to 72 hours. Studies comparing exparel single shot versus bupivacaine single shot have favored for the latter, which pharmacodynamically makes sense. A liposomal compound which slowly denatures to present an active component would seemingly be unlikely to match up against the higher concentration of said active component flood the desired site of action. In our study, the study team plans to measure the duration of the block with the addition of exparel in comparison to the duration of the block with a catheter which is connected to a pump continuously infusing a set rate of local anesthetics. Our primary research question is whether there is a statistically significant difference in pain control for 72 hours post-op in lower extremity orthopedic trauma when using Exparel versus a short-acting local anesthetic supplied via continuous infusion, in this case ropivacaine.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Recruiting
        • The George Washington University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Closed lower extremity orthopedic injury
  • Opioid naive patients
  • No other significant surgical injuries on admission as determined by study physician

Exclusion Criteria:

  • Allergy to local anesthetics
  • Multiple traumatic injuries
  • Weight less than 60 kg
  • Prior opioid use or risk of increased pain control needs as determined by PI
  • Chronic opioid use
  • Open fractures
  • Plastic surgery needed for complete closure
  • Patient has intraoperative cardiac arrest

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Bupivacaine
Drug: Bupivacaine
Patients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine with 10 cc of Exparel injected in the adductor space followed by 30 cc of 0.25% bupivacaine with 10 cc of Exparel in the sciatic nerve block. Injections will be completed by an anesthesia provider using astandard aseptic technique with ultrasound guidance. A 22 gauge 5-10cm needle is inserted with direct visualization under ultrasound and 2-5 cc aliquots are injected with aspiration repeated to ensure no vascular injury or injection until a total of 30 cc is injected into the adductor space and 40 cc is injected into the area surrounding the sciatic nerve. Exparel in this situation is being used off-label given that it is not FDA-approved for lower extremity nerve blocks. However, Exparel is commonly used in other nerve blocks and is FDA-approved for blocks such as the interscalene brachial plexus block.
Experimental: Exparel + Bupivacaine
Drug: Exparel + Bupivacaine
Patients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine injected in the adductor space followed by 30 cc of 0.25% bupivacaine in the sciatic nerve block. Injections will be completed by an anesthesia provider in the same manner as above. Catheters will be left in both spaces with post-operative pumps running 0.2% ropivacaine at 8 cc/hr.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score
Time Frame: 12 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
12 hours
Postoperative Pain Score
Time Frame: 24 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
24 hours
Postoperative Pain Score
Time Frame: 36 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
36 hours
Postoperative Pain Score
Time Frame: 48 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
48 hours
Postoperative Pain Score
Time Frame: 60 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
60 hours
Postoperative Pain Score
Time Frame: 72 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Morphine equivalents
Time Frame: Day 1
Morphine equivalents at 24 hours postoperatively
Day 1
Morphine equivalents
Time Frame: Day 2
Morphine equivalents at 24-48 hours postoperatively
Day 2
Morphine equivalents
Time Frame: Day 3
Morphine equivalents at 48-72 hours postoperatively
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCR256547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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