ACLPhase 4NCT06006624
Exparel vs Block for ACL Reconstruction
A Phase 4 study testing Exparel 30 mL, 0.5% bupivacaine and Dexamethasone in people with ACL and Postoperative Pain, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ACL, Postoperative Pain
- What is being tested?
- Exparel 30 mL, 0.5% bupivacaine and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 30 Oct 2024
- Phase
- Phase 4
- 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
- Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons
- Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis
- Age 18 and older
- English speaking
- Ability to complete surveys by phone or in person
- Ability to provide informed consent
Who cannot join
- Revision cases
- Multi-ligamentous knee injuries
- Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol
- ACL reconstruction utilizing non-bone-patellar tendon-bone autografts
- Allergies to study medications
- Non-English speakers
Show all 9Show fewer
- Known alcohol or narcotic abuse history
- Existing contract with a pain specialist due to underlying preoperative pain syndrome
- Preoperative opioid use within the 3 months prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.
- Conditions
- ACL, Postoperative Pain
- Being tested
- Exparel 30 mL, 0.5% bupivacaine, Dexamethasone, iPACK block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel 30 mLDrug
30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
0.5% bupivacaineDrug
5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
DexamethasoneDrug
10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal
iPACK blockDrug
iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ACL repair + Exparel + nerve block | Active comparator | 30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total) Receives: Drug: Exparel 30 mL; Drug: 0.5% bupivacaine; Drug: iPACK block |
| Group 2: ACL repair + Exparel + Dexamethasone + nerve block | Active comparator | 30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total) Receives: Drug: Exparel 30 mL; Drug: 0.5% bupivacaine; Drug: Dexamethasone; Drug: iPACK block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain
Measured: 14 days
Postoperative opioid use
assessed using a participant daily diary of how much medication was taken daily for pain
Measured: 14 days
Postoperative Pain #2
Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start21 Aug 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACLStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 154 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
- NCT06006624
- Sponsor's protocol ID
- SHAM2023-2163
- Status last verified
- Jun 2024
- First submitted
- 17 Aug 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Johns WL, Voskeridjian A, Miltenberg B, Muchintala R, Dodson CC, Cohen SB, Salvo J, Sherman M, Ciccotti MG, Hammoud S. Regional Anesthesia Utilizing Liposomal Bupivacaine, With or Without Dexamethasone, Provides Excellent Pain Control and Minimizes Opioid Consumption Following Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2026 Jan 8;14(1):23259671251401596. doi: 10.1177/23259671251401596. eCollection 2026 Jan.
PubMed 41522461
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06006624
- Acronym / sponsor ID
- SHAM2023-2163
- Conditions
- ACL, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Aug 2023 (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.
Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: ACL repair + Exparel + nerve block | Active comparator | Drug: Exparel 30 mL, Drug: 0.5% bupivacaine, Drug: iPACK block30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total) |
| Group 2: ACL repair + Exparel + Dexamethasone + nerve block | Active comparator | Drug: Exparel 30 mL, Drug: 0.5% bupivacaine, Drug: Dexamethasone, Drug: iPACK block30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons
- Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis
- Age 18 and older
- English speaking
- Ability to complete surveys by phone or in person
Key exclusion criteria (9 listed)
- Revision cases
- Multi-ligamentous knee injuries
- Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol
- ACL reconstruction utilizing non-bone-patellar tendon-bone autografts
- Allergies to study medications
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 |
|---|---|---|
| Exparel 30 mL30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block | Drug | Group 1: ACL repair + Exparel + nerve block, Group 2: ACL repair + Exparel + Dexamethasone + nerve block |
| 0.5% bupivacaine5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal | Drug | Group 1: ACL repair + Exparel + nerve block, Group 2: ACL repair + Exparel + Dexamethasone + nerve block |
| Dexamethasone10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal | Drug | Group 2: ACL repair + Exparel + Dexamethasone + nerve block |
| iPACK blockiPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block | Drug | Group 1: ACL repair + Exparel + nerve block, Group 2: ACL repair + Exparel + Dexamethasone + nerve block |
Primary outcome
Postoperative Pain
Time frame: 14 days
Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain
Postoperative opioid use
Time frame: 14 days
assessed using a participant daily diary of how much medication was taken daily for pain
Postoperative Pain #2
Time frame: 14 days
Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 41522461Johns WL, Voskeridjian A, Miltenberg B, Muchintala R, Dodson CC, Cohen SB, Salvo J, Sherman M, Ciccotti MG, Hammoud S. Regional Anesthesia Utilizing Liposomal Bupivacaine, With or Without Dexamethasone, Provides Excellent Pain Control and Minimizes Opioid Consumption Following Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2026 Jan 8;14(1):23259671251401596. doi: 10.1177/23259671251401596. eCollection 2026 Jan.
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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 4 study testing Exparel 30 mL, 0.5% bupivacaine and Dexamethasone in people with ACL and Postoperative Pain, 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 6 inclusion and 9 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 21 Jun 2024. 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?
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: 14 days). The study lists 3 primary outcomes in all. 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 NCT06006624, 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 21 Jun 2024.