Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT03599635
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2018-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pec Infiltration With Liposomal Bupivacaine for Breast Surgery
Sponsor:
Organization:
Raw JSON
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NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 7, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 6, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea/ Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'time from end of surgery through 72 hours after surgery', 'description': 'Description: To determine if liposomal bupivacaine Pec infiltration provides decreased peri-operative opioid usage when compared to incisional bupivacaine infiltration.', 'unitOfMeasure': 'mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximal Pain Scores - 1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 hour', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximal Pain Scores - 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. 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NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximal Pain Scores - 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximal Pain Scores - 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximal Pain Scores - 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improved Quality of Recovery Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '142.0', 'groupId': 'OG000', 'lowerLimit': '132.0', 'upperLimit': '148.0'}, {'value': '138.0', 'groupId': 'OG001', 'lowerLimit': '130.0', 'upperLimit': '143.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'To determine if a pectoralis 1 and 2 block with liposomal bupivacaine improves quality of recovery score post-operatively when compared to incisional bupivacaine infiltration. The scale used was QR15 with 0 to 150 scale; 0 is non of the time/poor, 150 all of the time/excellent.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effect in Patients With Breast Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'OG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'To observe the effect on chronic postoperative pain in patients who have breast surgery, measured with the Overall Benefit of Analgesia Score (OBAS), where 0 is minimal pain and 4 is maximum pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.'}, {'id': 'FG001', 'title': 'ODD Number = Surgeon Infiltration', 'description': '30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EVEN Number = PEC Block', 'description': 'Midazolam 0-2 mg IV. 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1 Hour', 'timeFrame': '1 hour', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.'}, {'measure': 'Maximal Pain Scores - 2 Hours', 'timeFrame': '2 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.'}, {'measure': 'Maximal Pain Scores - 6 Hours', 'timeFrame': '6 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.'}, {'measure': 'Maximal Pain Scores - 24 Hours', 'timeFrame': '24 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.'}, {'measure': 'Maximal Pain Scores - 48 Hours', 'timeFrame': '48 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.'}, {'measure': 'Maximal Pain Scores - 72 Hours', 'timeFrame': '72 hours', 'description': 'total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.'}, {'measure': 'Improved Quality of Recovery Score', 'timeFrame': '1 year', 'description': 'To determine if a pectoralis 1 and 2 block with liposomal bupivacaine improves quality of recovery score post-operatively when compared to incisional bupivacaine infiltration. The scale used was QR15 with 0 to 150 scale; 0 is non of the time/poor, 150 all of the time/excellent.'}, {'measure': 'Effect in Patients With Breast Surgery', 'timeFrame': '1 year', 'description': 'To observe the effect on chronic postoperative pain in patients who have breast surgery, measured with the Overall Benefit of Analgesia Score (OBAS), where 0 is minimal pain and 4 is maximum pain.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare pain control after breast surgery using either liposomal bupivacaine or bupivacaine when infiltrated during an ultrasound guided pectoralis 1 and 2 block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these types of surgeries.', 'detailedDescription': "For the Pec infiltration, the patient will be in the supine position. The pectoralis major and pectoralis minor muscle layers will be identified via ultrasound. Using sterile technique, a nerve block needle will be inserted and advanced under ultrasound guidance until it is below the fascial covering of the pec minor muscle layer. Gentle aspiration for air or blood will be performed in 5cc incremental doses. Then injection of 10 mL of bupivacaine 0.25% with epinephrine 1:200,000 and 10mL of a mixture of liposomal bupivacaine and saline (5 mL liposomal bupivacaine and 5 mL saline) for a total injection for pec 1 block of 20 mL. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection the needle will be removed. The investigators will then use the ultrasound probe to identify the second rib on anterolateral chest wall and move the probe to the 4th rib. Here the investigators will identify the pec minor and serratus anterior muscles. They will advance their needle under ultrasound-guidance beneath pec minor and above serratus anterior. Here an injection 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline for a total volume of 30ml for Pec 2. block will occur.\n\nUpon completion of the injection, the needle will then be removed and the patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure.\n\nIf deemed necessary for coverage the surgeon will be allowed to inject additional local anesthetic up to a maximum of 40 mL of 0.25% bupivacaine. This will be noted in the chart.\n\nFor the surgeon infiltration, the patient will be brought directly to the operating room where intraoperative anesthetic with an opioid-sparing MAC technique will be provided as described below. Just prior to the skin incision, 0.25% bupivacaine will be used to infiltrate the dermis and subcutaneous space in the proposed incision. Throughout the procedure, additional incisional bupivacaine infiltration into the surrounding tissues will be performed as needed for local anesthesia. A total of up to 30 mL of 0.25% bupivacaine will be divided equally for the two sides of the incision. An additional 5 mL of 0.25% bupivacaine will be infiltrated into the pectoralis major muscle at the deep margin of resection. Accidental intravascular injection is minimized by continuous needle movement and frequent aspiration.\n\nThe following vital signs will be monitored throughout the procedure: Heart rate, blood pressure, oxygen saturation, and respirations, and patient's state of consciousness. The investigators will monitor the patient until they are brought to the operating room for surgery.\n\nAll patients will receive multimodal analgesia in the preoperative area. They will receive 975 mg of oral acetaminophen and 300 mg of gabapentin orally prior to surgery. 30 mg of ketorolac will be given just prior to closure in the operating room.\n\nThe intraoperative anesthetic will be an opioid-sparing MAC anesthetic. Patients will receive IV midazolam 0-2 mg followed by 40-100mg of IV lidocaine, and followed by a propofol infusion with 2 mg/ml of ketamine. Opioids will be avoided unless HR or BP increases by 20 % above baseline. Then only short acting opioids (fentanyl) will be given. If patients are unable to tolerate procedure under MAC they would be converted to a general anesthetic with an laryngeal mask airway (LMA).\n\nIn the recovery room if the patient experiences pain greater than 5/10 they will receive either IV or oral pain medications. If pain score is less than 5 patients will get non opioid medications unless the patient desires an opioid medication.\n\nWhen the operation is complete the patient will either be brought to the PACU or Phase II. Each day a member of the research team will call and evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score (scores will be evaluated at 1 hr, 2 hr, 6hrs, 24hrs, 48hrs, 72hrs). They will record daily opioid use, any modality related complications, how many phone calls were made regarding pain control and modality related complications. At time period 72 hours a Quality of recovery survey (see appendix) and OBAS (see appendix) survey will be presented to patient.\n\nAt 3 months, 6 months, and 12 months patients will be called to answer a survey with regards to chronic pain.\n\nPatients will be instructed to take acetaminophen 1000 mg every 8 hours while at home and alternate that every four hours with ibuprofen 800 mg every 8 hours. They will be given a prescription of opioid pain medications either oxycodone or hydrocodone and will be instructed to take as needed for pain."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • All patients undergoing partial mastectomy procedures.\n\n * Ages 18-75\n\nExclusion Criteria:\n\n* • Patient on chronic anticoagulation\n\n * Pregnant women\n * Non-english speaking patients\n * Any individuals who are unable to give informed consent\n * Any individual with diminished capacity to give informed consent\n * Allergy to local anesthetics\n * Patients who remain intubated overnight after surgery or who are unable to provide information regarding their pain immediately postoperatively\n * Daily use of opioid for more than three weeks\n * Significant liver disease, defined as liver enzymes greater than 3x the upper limit of normal\n * Lack of patient cooperation including those patients who refuse a MAC anesthetic\n * Contraindication to regional anesthesia\n\n * Infection at injection site\n * Inability to guarantee sterile equipment or sterile conditions for the block\n * Patient refusal\n * Severe Coagulopathy or bleeding disorder'}, 'identificationModule': {'nctId': 'NCT03599635', 'briefTitle': 'Pec Infiltration With Liposomal Bupivacaine for Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Ultrasound-guided Pec Infiltration With Liposomal Bupivacaine for Breast Surgery: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'ANES-2017-25584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'liposomal bupivacaine', 'description': 'These patients will receive liposomal bupivacaine for a pectoralis block infiltration by the anesthesiologist.', 'interventionNames': ['Drug: liposomal bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine', 'description': 'These patients will receive incisional bupivacaine infiltration by the surgeon.', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'liposomal bupivacaine', 'type': 'DRUG', 'description': 'Experimental', 'armGroupLabels': ['liposomal bupivacaine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Active Comparator', 'armGroupLabels': ['bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'M Health Ambulatory Surgery Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jason Habeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}