A Phase 4 interventional study of Exparel and Exparel in Pain, Postoperative, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by University of Minnesota · Phase 4, 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 88th largest by enrollment, is one of 15 that started in 2019, is one of 52 in phase 4, and was the 35th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
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: 18 Years and older · female · 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. 15 started in 2019.
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:
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
University of Minnesota has 7 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
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.
Evaluating the safety and efficacy of EXPAREL (Liposomal Bupivacaine ) for pain control in patients undergoing scheduled cesarean section by giving it either as infiltration in Transversus Abdominis Plane after finishing the procedure or through wound infiltration into the fascia prior to closure of skin
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:
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.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
20-mL dose of EXPAREL 266 mg expanded in volume with 20 mL normal saline plus 20 mL 0.25% bupivacaine for a total volume of 60 mL m.A 2-point classic TAP block will be performed under ultrasound guidance within 1 hour (± 30 minutes) following skin incision closure of the C-section.
Drug: Exparel
20 mL of EXPAREL 266 mg expanded in volume with 40 mL normal saline for a total volume of 60 mL, infiltrated in the fascia prior to skin closure with attention to infiltrate the angles of the incision.
Drug: Exparel
Total opioid consumption
Total opioid medication use by patient after having cesarean section
Time frame: 72 hours
Time to first rescue opioid pain medication
Time till the patient asks for opioid medication for breakthrough pain
Time frame: 72 hours
Percentage of opioid-free subjects
Percentage of patients didn't require any opioid medications after the cesarean section
Time frame: 24,48, and 72 hours
Patient's satisfaction
Patient's satisfaction questionnaire with pain control
Time frame: through 72 hours post-op or at discharge
VAS (visual analogue scale) pain scores
pain level assessment using visual assessment pain score which ranges from zero for no pain to 10 intolerable pain
Time frame: at 6, 12, 18, 24, 30, 36, 42, 48, and 72 hours after surgery
Number of participants with EXPAREL related adverse events
side effects of EXPAREL
Time frame: through day 14 post-op
Allergic reactions attributable to local anesthetic use
Such as allergies, rash etc...
Time frame: through day14 post-op
Wound complications
cesarean section wound complications like infection, hematoma, and dehiscence
Time frame: through day 14 post-op
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine