ESP Block for Post Cesarean Analgesia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2023-11-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ESP Block

Standard of care analgesic regimen with ESP Block

Group Type EXPERIMENTAL

Erector Spinae Plane (ESP) Block

Intervention Type PROCEDURE

ESP Block with liposomal bupivacaine and immediate release bupivacaine

bupivacaine liposome injectable suspension

Intervention Type DRUG

133 mg liposomal bupivacaine per side.

bupivacaine

Intervention Type DRUG

20 ml bupivacaine 0.25% per side.

Control

Standard of care analgesic regimen

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erector Spinae Plane (ESP) Block

ESP Block with liposomal bupivacaine and immediate release bupivacaine

Intervention Type PROCEDURE

bupivacaine liposome injectable suspension

133 mg liposomal bupivacaine per side.

Intervention Type DRUG

bupivacaine

20 ml bupivacaine 0.25% per side.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No