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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00022425 | Other Identifier | Atrium |
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The purpose of this study is to compare the effectiveness of local wound infiltration of EXPAREL® (liposomal bupivacaine) with bupivacaine HCl compared to active control with bupivacaine HCl alone following elective primary or repeat cesarean delivery with spinal anesthesia.
Pain in the postpartum period is an important concern of new mothers. With over one-third of deliveries ending in cesarean section, effective postoperative pain control is essential in the care of postpartum patients.1 Improved pain control in the postpartum period after cesarean delivery (CD) is associated with improved overall maternal health and satisfaction, decreased postpartum depression, shortened hospital stay, decreased opioid consumption, and decreased healthcare costs, as well as possible facilitation of early contact of mothers with their infants.2 Pain control is of great concern to women during and after cesarean delivery.3 Pain relief and patient satisfaction are inadequate in many cases. Pain may be severe, last at least 48-72 hours, and may impair early postoperative recovery.
Opioids are primarily used in the post-operative period. Although opioids are safe to use in breastfeeding mothers, they are not without unwanted side effects.4 Local anesthetics and parenteral NSAIDs are also beneficial adjuncts to regional or general anesthesia after CD by reducing opioid consumption and improving pain relief.5 In addition, field block with wound infiltration with local anesthetic is an effective and safe adjunct for pain control. Previous studies have shown improved postoperative pain control with TAP (transversus abdominis plane) blocks with bupivacaine in hysterectomy patients.4 Another study has looked at the effects of bupivacaine-soaked spongostan placed in cesarean wounds.2 EXPAREL®® (Parsippany, NJ: Pacira Pharmaceuticals, Inc) is a liposomal form of bupivacaine. Its mechanism of action is by DepoFoam® technology, in which microscopic, polyhedral molecules that contain aqueous chambers with liposomal bupivacaine that are slowly released over hours to days with erosion and rearrangement of lipid membranes.6 The slow release of local anesthetic extends its pharmacologic effect and provides longer postsurgical pain control for up to 72 hours.6 This method of delivery of local anesthetic has the potential to decrease postoperative opioid consumption.7 EXPAREL® is an FDA-approved medication for the general use of postoperative surgical site pain control. Paracervical block is the only obstetric contraindication to EXPAREL® use. The purpose of this study is to compare the effectiveness of local wound infiltration of EXPAREL® (liposomal bupivacaine) with bupivacaine HCl compared to active control with bupivacaine HCl alone following elective primary or repeat cesarean delivery with spinal anesthesia. The investigators hypothesize that narcotic use during postoperative hospitalization will be decreased using liposomal bupivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine + Bupivacaine HCL | Experimental | Liposomal bupivacaine + bupivacaine HCl surgical-site incision infiltration following spinal anesthesia |
|
| Bupivacaine HCl surgical-site incision infiltration | Active Comparator | Bupivacaine HCl surgical-site incision infiltration following spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Bupivacaine liposome injectable suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of total opioid MME (milligram morphine equivalents) consumed at 24, 48 and 72hrs post-op | 3.1 To compare total opioid consumption through 72-hours following EXPAREL® + bupivacaine HCl surgical-site infiltration versus bupivacaine HCl alone at elective primary or repeat cesarean delivery after spinal anesthesia. 3.2 Primary outcome of this study is total opioid consumption measured in milligram morphine equivalents (MME) at 24-, 48- and 72-hours postoperatively and total MME for duration of hospital admission. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| time to initial rescue analgesia administration | Time in hours and minutes | 24 hours |
| Numeric Pain Rating Score at 72 hours Postoperative | postoperative pain assessment with NRS (Numeric Pain Rating Score). NRS score is comprised of 4 pain questions with the patient rating each one on a scale of 0(no pain) to 10(worst pain imaginable). Lower scores are favorable. |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility based on gender female
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| Name | Affiliation | Role |
|---|---|---|
| Amy Boardman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health | Charlotte | North Carolina | 28203 | United States |
IPD will not be shared
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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 |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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randomized, single-blind, active-controlled trial
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Patients will be blinded to treatment arm to which patients are assigned.
| Bupivacaine HCl | Drug | Bupivacaine HCl surgical-site incision infiltration |
|
|
| 72 hours |
| Overall Benefit of Analgesia Score at 72 hours Postoperative | postoperative pain assessment with OBAS (Overall Benefit of Analgesia Score). The OBAS is comprised of 7 questions each being scored by the patient from 0(minimal pain) to 4(maximum imaginable pain). Each question is then added up to total the overall benefit of analgesia score. Lower scores are favorable. | 72 hours |
| Length of hospital stay | measured in days and hours | 72 hours |
| Initiation of breastfeeding | yes/no and time to initiation as measured in days and hours | 72 hours |
| Postpartum depression scores | PHQ-9 postpartum depression scores. Possible range is 0-27. Lower scores mean less depression. | 72 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |