A Phase 2 interventional study of Liposomal Bupivacaine and Bupivacaine in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Supportive care
Among 73 studies in Breast Neoplasms by Case Comprehensive Cancer Center — 7 open to participants now, 10 under way, none of them phase 3. Breast Neoplasms · Case Comprehensive Cancer Center.
Among the 73 studies in Breast Neoplasms by Case Comprehensive Cancer Center, this one is the 45th largest by enrollment of the 54 interventional ones, is one of 3 that started in 2018, is one of 15 in phase 2, and was the 55th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →7 of the 73 studies in Breast Neoplasms by Case Comprehensive Cancer Center are open now, in 1 country. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →73 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 3 started in 2018.
Median enrollment 22 across the 54 interventional studies, 45 across the 18 observational. Of the 49 that completed or were terminated, 9 (18%) have results posted.
Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
5 of the studies in Breast Neoplasms by Case Comprehensive Cancer Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05825482Case Comprehensive Cancer CenterBreast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout® | 2026-12 |
| NCT04362826Case Comprehensive Cancer CenterStudy to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer | 2026-12 |
| NCT05970107Case Comprehensive Cancer CenterAxillary Node Dissection w or w/o LVB in Node Positive Breast Cancer Patients | 2026-12-01 |
| NCT06926530Case Comprehensive Cancer CenterHerbs & Supplements in Breast Cancer Usage, Impact, and Personalized Approaches for Diverse Populations | 2027-03 |
| NCT07906990Case Comprehensive Cancer CenterCulinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer | 2027-06-03 |
Among the 73 studies in Breast Neoplasms by Case Comprehensive Cancer Center, from their registry updates:
The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.
This is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in providing postsurgical analgesia in patients undergoing unilateral abdominally-based breast reconstruction at time of mastectomy.
OBJECTIVES
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:
Concurrent or recent medical condition that could interfere with study participation including:
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Drug: Liposomal Bupivacaine · Drug: Bupivacaine · Drug: Patient-Controlled Analgesia Pump · Drug: Oral Narcotic
This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Drug: Bupivacaine · Drug: Patient-Controlled Analgesia Pump · Drug: Oral Narcotic
20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks.
Also known as: Exparel
20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.
Also known as: Sensorcaine-Methyl Paraben Free (MPF) Spinal, Sensorcaine-MPF, Sensorcaine, ReadySharp Bupivacaine, P-Care M, Marcaine Spinal, Marcaine Preservative Free, Marcaine, Bupivacaine Spinal
Drug pages: Narcotics · Opioids
The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.
Also known as: intravenous narcotic
Drug pages: Narcotics · Opioids
Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.
total post-operative narcotic utilization
post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.
Time frame: Up to 72 hours post-operative
at rest pain score on visual analog scale
0-100 score of self-reported pain
Time frame: Up to 72 hours post-operative
coughing pain score on visual analog scale
0-100 score of self-reported pain
Time frame: Up to 72 hours post-operative
number of incidents of nausea reported by patient
self-report of nausea
Time frame: Up to 72 hours post-operative
number of incidents of vomiting reported by patient
number of times a patient vomits
Time frame: Up to 72 hours post-operative
time to first ambulation
Time frame: Up to 72 hours post-operative
time to first liquid intake
Time frame: Up to 72 hours post-operative
time to first solid intake
Time frame: Up to 72 hours post-operative
No study locations are listed for this record.
This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine
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