ESP Block for Post Cesarean Analgesia

Phase 4

Completed

Conditions: Cesarean Section Complications

Interventions: Procedure: Erector Spinae Plane (ESP) Block
Drug: bupivacaine liposome injectable suspension
Drug: bupivacaine

Registration Number: NCT05664958

Lead Sponsor: Duke University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 150

Inclusion Criteria

Patients ≥18 years of age with a term pregnancy of 37 to 42 weeks and American Society of Anesthesiologists Physical Status Classification II or III scheduled to undergo elective CD.

Exclusion Criteria

≥3 prior CDs, pre-pregnancy body mass index >40 kg/m2, planned concurrent surgical procedure other than tubal ligation, chronic pain or chronic opioid therapy, any clinically significant event or condition uncovered during surgery (eg, excessive bleeding, acute sepsis) that might render the patient medically unstable or complicate the patient's postsurgical course, or allergy or contraindication to any component of the multimodal analgesic regimen.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP Block	bupivacaine liposome injectable suspension	Standard of care analgesic regimen with ESP Block
ESP Block	Erector Spinae Plane (ESP) Block	Standard of care analgesic regimen with ESP Block
ESP Block	bupivacaine	Standard of care analgesic regimen with ESP Block

Primary Outcome Measures

Name	Time	Method
Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery	0-48 hours after cesarean delivery	Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery

Secondary Outcome Measures

Name	Time	Method
Postoperative Opioid Consumption at 24 Hours	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 to First Postsurgical Opioid Rescue Medication	0-48 hours	Time to first rescue opioid medication used for the treatment of breakthrough pain
Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores	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').
Number of Participants With Postoperative Nausea and Vomiting	0-48 hours	Occurrence of nausea and vomiting 0-48 h after cesarean delivery
Number of Participants With the Need for Rescue Antiemetics	0-48 hours	Number of participants who needed medications to treat nausea and vomiting
Number of Participants With Pruritus	0-48 hours	Number of participants who complained of pruritus
Number of Participants With the Need for Rescue Antipruritics	0-48 hours	Number of participants who needed medications for treatment for pruritus
Number of Participants Not Receiving Any Rescue Opioids Postoperatively	0-48 hours	Number of participants who did not need any opioids for break through pain