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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP (Transversus Abdominis Plane) block | Experimental | 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. |
|
| Wound infiltration | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | TAP (Transversus Abdominis Plane) block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption | Total opioid medication use by patient after having cesarean section | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue opioid pain medication | Time till the patient asks for opioid medication for breakthrough pain | 72 hours |
| Percentage of opioid-free subjects | Percentage of patients didn't require any opioid medications after the cesarean section |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiba Mustafa, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Exparel | Drug | Wound infiltration |
|
|
| 24,48, and 72 hours |
| Patient's satisfaction | Patient's satisfaction questionnaire with pain control | 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 | 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 | through day 14 post-op |
| Allergic reactions attributable to local anesthetic use | Such as allergies, rash etc... | through day14 post-op |
| Wound complications | cesarean section wound complications like infection, hematoma, and dehiscence | through day 14 post-op |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D017670 |
| Sodium Compounds |