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No accrual
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine + Bupivacaine | Experimental | 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. |
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| Bupivacaine | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| total post-operative narcotic utilization | post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine. | Up to 72 hours post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| at rest pain score on visual analog scale | 0-100 score of self-reported pain | Up to 72 hours post-operative |
| coughing pain score on visual analog scale | 0-100 score of self-reported pain |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant
Concurrent or recent medical condition that could interfere with study participation including:
Body weight of less than 50 kg
Participated in another study involving an investigational medication within the prior 30 days
Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Risal Djohan, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D009294 | Narcotics |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Medication utilized will be blinded in the chart per inpatient pharmacy.
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| Bupivacaine | Drug | 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. |
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| Patient-Controlled Analgesia Pump | Drug | The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate. |
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| Oral Narcotic | Drug | Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1. |
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| Up to 72 hours post-operative |
| number of incidents of nausea reported by patient | self-report of nausea | Up to 72 hours post-operative |
| number of incidents of vomiting reported by patient | number of times a patient vomits | Up to 72 hours post-operative |
| time to first ambulation | Up to 72 hours post-operative |
| time to first liquid intake | Up to 72 hours post-operative |
| time to first solid intake | Up to 72 hours post-operative |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000588 |
| Amines |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |