Duke University Hospital
Durham, North Carolina, 27701, United States
NCT Number: NCT05664958
The purpose of this pilot study is to assess the analgesic efficacy of Erector Spinae Plane block (ESPB) with liposomal bupivacaine in women undergoing cesarean delivery and receiving a postoperative multimodal analgesic regimen as assessed by the dose of rescue postoperative opioids compared to a historical control group of women receiving the same multimodal regimen but with no truncal blocks. This will be a case control study with a prospective and a retrospective component. Women undergoing elective cesarean delivery under spinal or combined spinal epidural anesthesia will be approached to participate in the prospective open label component of the study. Cases will be matched in a 1:4 ratio by age, race, history of prior cesarean delivery, and insurance status with historical controls who received the same multimodal analgesic regimen but no truncal blocks. We plan to enroll 30 subjects for the prospective arm of the study and 120 for the retrospective arm.
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Female
Interventional
Phase 4
Durham, North Carolina, 27701, United States
This will be a case control study with a prospective and a retrospective component. Women undergoing elective cesarean delivery under spinal or combined spinal epidural anesthesia will be approached to participate in the prospective open label component of the study. Those women will receive the standard of care intraoperative and postoperative analgesic regimen used at Duke university incorporating 100 mcg intrathecal morphine, intraoperative acetaminophen 975 mg PR and ketorolac 15 mg IV and postoperative scheduled oral acetaminophen 975 mg every 6 hours, scheduled 15 mg IV ketorolac for 3 doses every 6 hours followed by oral ibuprofen 600 mg every 6 hours. At the end of surgery, a bilateral ESPB will be performed under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.
Cases will be matched in a 1:4 ratio by age, race, history of prior cesarean delivery, and insurance status with historical controls who received the same multimodal analgesic regimen but no truncal blocks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ESP Block with liposomal bupivacaine and immediate release bupivacaine
133 mg liposomal bupivacaine per side.
20 ml bupivacaine 0.25% per side.
Time frame: 0-48 hours after cesarean delivery
Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery
Time frame: 0-24 hours
Total dose of rescue opioids used in mg oral morphine equivalents (OME) at 24 hours after cesarean delivery. OME are approximations of the equianalgesic effects of other opioids compared to oral morphine. Thus, OMEs indicate how much of the reference drug oral morphine would be required to treat pain as effectively as the comparison opioid.
Time frame: 0-48 hours
Time to first rescue opioid medication used for the treatment of breakthrough pain
Time frame: 0-48 hours
Area under the curve (AUC) of verbal rating scale (VRS) pain intensity scores, lower scores indicate a better outcome. The VRS consists of a scale of 0 ('no pain') to 10 ('pain as bad as it could possibly be').
Time frame: 0-48 hours
Occurrence of nausea and vomiting 0-48 h after cesarean delivery
Time frame: 0-48 hours
Number of participants who needed medications to treat nausea and vomiting
Time frame: 0-48 hours
Number of participants who complained of pruritus
Time frame: 0-48 hours
Number of participants who needed medications for treatment for pruritus
Time frame: 0-48 hours
Number of participants who did not need any opioids for break through pain
Duke University
Other
Erector Spinae Plane Block With Liposomal Bupivacaine for Post Cesarean Delivery Analgesia: A Pilot Study
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