Liposomal BupivacainePhase 4NCT06547255

Exparel Versus Bupivacaine in Post-operative Pain Control

A Phase 4 study testing Bupivacaine liposome injectable suspension in people with Liposomal Bupivacaine, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Liposomal Bupivacaine
What is being tested?: Bupivacaine liposome injectable suspension
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: 21 Aug 2024to 1 Jul 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and nonpregnant female adults (≥18 years of age) with American Society of Anesthesiologists physical status classification 1, 2, or 3 who were scheduled to undergo bilateral third molar extraction (extraction of all 4 third molars) under local anesthesia and general anesthesia Study participants were required to have full or partial bony impaction of both mandibular third molars.

Who cannot join

history of allergy or contraindication to amide-type local anesthetics, epinephrine, or opioids a history of any disease or condition or recent use of any drug that, in the opinion of the investigator, might increase the risk of surgery or interfere with study evaluations any use of long-acting opioids, nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen within 3 days before screening or use of opioids within 24 hours of screening Patient that is pregnant or suspected to be pregnant Adults that cannot speak English, adults that are unable to consent on their own, or persons that are listed as vulnerable individuals will not be part of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Western Reserve University
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Exparel Versus Bupivacaine in Post-operative Pain Control Following Bilateral Third Molar Extractions: A Single-blind Randomized Clinical Trial

This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine

Read the detailed description

The main purpose of this prospective, randomized study was to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine. At the end of the third molar extraction surgical procedure and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), patients will, at random, receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) or with standard 3mL standard bupivacaine. Electronic home questionnaires will be completed by the patient following the procedure for 96 hours to evaluate these clinical parameters

Conditions: Liposomal Bupivacaine
Being tested: Bupivacaine liposome injectable suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine liposome injectable suspensionDrug
Also called standard bupivacaine
At the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia.

Study groups in NCT06547255
Study group	Role	What they receive
standard bupivacaine	Active comparator	patient receive mandibular and maxillary infiltrations with 3mL of 0.5% standard bupivacaine. Receives: Drug: Bupivacaine liposome injectable suspension
liposomal bupivacaine	Experimental	patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) Receives: Drug: Bupivacaine liposome injectable suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Post Operative Pain Intensity (Visual Analog Scale VAS)
Post operative pain was assessed using 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worse imaginable pain. Patients recorded pain score twice daily (morning and evening) for four consecutive post operative days using a standardized at home questionnaire
Measured: Twice daily (morning and evening) from 0-96 hours post-operatively

Secondary outcomes (2)

Post Operative NSAID/Acetaminophen Consumption
Post operative analgesic consumption was recorded using a standardized at home questionnaire. Patients document the number of NSAIDS (Ibuprofen 600mg) and Acetaminophen tablets taken daily for four consecutive postoperative days.
Measured: Daily from 0 to 96 hours post-operatively
Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use
post operative opioid consumption was recorded using a standardized at home qusetionnaire. patients documented the number of (Hydrocodone-Acetaminophen 5/325) tablets taken daily for four consecutive postoperative days
Measured: daily from 0 to 96 hours post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 20241 Jul 2025

First posted9 Aug 2024
Study start21 Aug 2024
Primary completion1 Jul 2025
Study completion1 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liposomal BupivacaineStudies 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: Single blind
Who is masked: Participant
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06547255
Sponsor's protocol ID: STUDY20221478
Status last verified: Jun 2026
First submitted: 7 Aug 2024
Last updated: 28 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Exparel and Dexamethasone
Postoperative Pain, Shoulder Arthroscopic Surgeries
Not yet recruitingPhase 4
Smart Knee Evaluation of Exparel and Zynrelef in TKA Recovery
Total Knee Anthroplasty
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
RecruitingPhase 4
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
Local Analgesia Via Infiltration
Enrolling by invitationPhase 4
Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery
Moderate-to-severely Painful Ankle Surgery

All Liposomal Bupivacaine trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exparel Versus Bupivacaine in Post-operative Pain Control Following Bilateral Third Molar Extractions: A Single-blind Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06547255
Acronym / sponsor ID: STUDY20221478
Conditions: Liposomal Bupivacaine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Study start: 21 Aug 2024 (actual)
Primary completion: 1 Jul 2025 (actual)
Study completion: 1 Jul 2025 (actual)
First posted: 9 Aug 2024 (actual)
Results: Posted 28 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
standard bupivacaine	Active comparator	Drug: Bupivacaine liposome injectable suspensionpatient receive mandibular and maxillary infiltrations with 3mL of 0.5% standard bupivacaine.
liposomal bupivacaine	Experimental	Drug: Bupivacaine liposome injectable suspensionpatient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Male and nonpregnant female adults (≥18 years of age) with American Society of Anesthesiologists physical status classification 1, 2, or 3 who were scheduled to undergo bilateral third molar extraction (extraction of all 4 third molars) under local anesthesia and general anesthesia Study participants were required to have full or partial bony impaction of both mandibular third molars.

Key exclusion criteria (1 listed)

history of allergy or contraindication to amide-type local anesthetics, epinephrine, or opioids a history of any disease or condition or recent use of any drug that, in the opinion of the investigator, might increase the risk of surgery or interfere with study evaluations any use of long-acting opioids, nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen within 3 days before screening or use of opioids within 24 hours of screening Patient that is pregnant or suspected to be pregnant Adults that cannot speak English, adults that are unable to consent on their own, or persons that are listed as vulnerable individuals will not be part of the study

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
Bupivacaine liposome injectable suspensionAlso: standard bupivacaineAt the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia.	Drug	liposomal bupivacaine, standard bupivacaine

Primary outcome

Post Operative Pain Intensity (Visual Analog Scale VAS)
Time frame: Twice daily (morning and evening) from 0-96 hours post-operatively
Post operative pain was assessed using 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worse imaginable pain. Patients recorded pain score twice daily (morning and evening) for four consecutive post operative days using a standardized at home questionnaire

2 secondary outcomes

Post Operative NSAID/Acetaminophen Consumption
Time frame: Daily from 0 to 96 hours post-operatively
Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use
Time frame: daily from 0 to 96 hours post-operatively

Results and safety

Results posted to the registry on 28 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Bupivacaine	50	42
Liposomal Bupivacaine	50	40

Primary outcome: Post Operative Pain Intensity (Visual Analog Scale VAS)

Time frame: Twice daily (morning and evening) from 0-96 hours post-operatively. Mean (Standard Deviation). Unit: VAS score 0-10

Measure	Liposomal Bupivacaine n = 40	Standard Bupivicaine n = 42
Evening of surgery	5.7 (1.9)	6.9 (1.4)
Day 1 morning	4.6 (1.7)	6.4 (2.5)
Day 1 evening	3.9 (1.7)	6.5 (2.7)
Day 2 morning	3.3 (1.8)	6.9 (2.4)
Day 2 evening	2.9 (1.8)	7.0 (2.2)
Day 3 morning	2.6 (1.6)	6.8 (2.2)
Day 3 evening	2.4 (1.4)	6.8 (2.3)
Day 4 morning	1.6 (1.8)	6.4 (2.2)

Population analysed: A total of 82 participants completed the study and were included in the final analysis (40 in the liposomal bupivacaine group and 42 in the standard bupivacaine group). Only participants with complete post operative pain data were included.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: from the time of surgery to 96 hours post operatively. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liposomal Bupivacaine	0 of 40 (0%)	7 of 40 (17.5%)	0 of 40
Standard Bupivicaine	0 of 42 (0%)	5 of 42 (11.9%)	0 of 42

Limitations and caveats (from the sponsor): This study have several limitations: * Operators were not blinded to group allocation which may introduce performance bias * Surgical difficulty and procedure duration were not standardized and may have varied between participants * Procedure has been performed by residents at different level of training which may have influenced outcomes * Baseline difference in ASA Physical status were present between the study groups

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Liposomal Bupivacaine

Not yet recruitingPhase 4
Exparel and Dexamethasone
Postoperative Pain, Shoulder Arthroscopic Surgeries
Not yet recruitingPhase 4
Smart Knee Evaluation of Exparel and Zynrelef in TKA Recovery
Total Knee Anthroplasty
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
RecruitingPhase 4
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
Local Analgesia Via Infiltration
Enrolling by invitationPhase 4
Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery
Moderate-to-severely Painful Ankle Surgery

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.

Faisal Quereshy, MD principal investigator

Case Western Reserve University

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 Bupivacaine liposome injectable suspension in people with Liposomal Bupivacaine, run by Case Western Reserve University 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 1 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: finished, as of the sponsor's last update on 28 Jul 2026. 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?

Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Post Operative Pain Intensity (Visual Analog Scale VAS) (time frame: Twice daily (morning and evening) from 0-96 hours post-operatively). 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 NCT06547255.

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 28 Jul 2026.