A Phase 1 interventional study of Exparel in Postoperative Pain Management, sponsored by Pacira Pharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by Pacira Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment
Among 92 studies testing Liposomal Bupivacaine in Pain, Postoperative — 13 open to participants now, 14 under way, 2 of them phase 3. Liposomal Bupivacaine · Pain, Postoperative.
Among the 92 studies testing Liposomal Bupivacaine in Pain, Postoperative, this one is the 77th largest by enrollment, is one of 10 that started in 2018, is one of 8 in phase 1, and was the 38th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 15 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →13 of the 92 studies testing Liposomal Bupivacaine in Pain, Postoperative are open now, in 3 countries. Each count lists the studies.
Liposomal Bupivacaine: first FDA approval 2011 (EXPAREL), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 12 Years to 16 Years · all sexes · healthy volunteers too.
The full table on the hub →92 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 10 started in 2018.
Median enrollment 80 across the 92 interventional studies. Of the 61 that completed or were terminated, 41 (67%) have results posted.
12 of 92 have an industry lead sponsor. The 10 most frequent:
Pacira Pharmaceuticals, Inc is the lead sponsor of 102 studies on the registry; 3 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.
25 studies in Pain, Postoperative by Pacira Pharmaceuticals, Inc: 1 open now, 1 under way, none of them phase 3. Of 24 finished, 19 (79%) have results posted.
Among the 25 studies in Pain, Postoperative by Pacira Pharmaceuticals, Inc, this one is the 21st largest by enrollment of the 24 interventional ones, is one of 2 that started in 2018, is one of 5 in phase 1, and was the 21st registered.
Pacira Pharmaceuticals, Inc’s Pain, Postoperative studies by the year they started, since 2004.
8 of the studies testing Liposomal Bupivacaine in Pain, Postoperative that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06350981Phase 3Foundation for Orthopaedic Research and EducationAnalgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion | 2027-01-01 |
| NCT06077422Phase 3Rutgers, The State University of New JerseyExparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain | 2027-01-11 |
| NCT03737292Milton S. Hershey Medical CenterLiposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy | 2026-12 |
| NCT06271265Pacira Pharmaceuticals, IncStudy to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery | 2027-01 |
| NCT07689162Washington University School of MedicineLiposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia | 2027-06 |
Among the 92 studies testing Liposomal Bupivacaine in Pain, Postoperative, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Pacira Pharmaceuticals, Inc’s 25 in Pain, Postoperative:
Nothing recorded among them since 2026-09-25.
Primary objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
Secondary objective: The secondary objective of this study is to evaluate the safety of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXAPREL when administered intraoperatively at the end of surgery via local infiltration. Fifteen pediatric subjects 12 to less than 17 years of age undergoing spinal surgeries are planned for enrollment.
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the investigator, would preclude them from study participation.
Subjects will undergo their pre-planned spinal surgeries per the institution's standard of care. On Day 1, eligible subjects will receive a single dose of EXPAREL 4 mg/kg intraoperatively at the end of surgery via local infiltration into the surgical site. There is no required length of stay in the hospital; subjects may be discharged based on the medical judgment of the treating physician.
A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit will be made on Day 30 to all subjects who received study drug.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Administration of an drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
In addition, the subject will be ineligible to receive study drug if the following criterion is met during surgery:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose of EXPAREL 4 mg/kg
Drug: Exparel
EXPAREL 4 mg/kg
AUC of EXPAREL concentration
Area under the concentration curve for EXPAREL
Time frame: 0-96 hours
Incidence of treatment-emergent adverse events and serious adverse events
Incidence of treatment-emergent adverse events and serious adverse events through 30 days
Time frame: 0-30 days
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine