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Completed

NCT Number: NCT05664958

ESP Block for Post Cesarean Analgesia

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Hospital

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erector Spinae Plane (ESP) Block

Procedure

ESP Block with liposomal bupivacaine and immediate release bupivacaine

Bupivacaine liposome injectable suspension

Drug

133 mg liposomal bupivacaine per side.

Bupivacaine

Drug

20 ml bupivacaine 0.25% per side.

Primary outcomes

  1. Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery

    Time frame: 0-48 hours after cesarean delivery

    Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery

Secondary outcomes

  1. Postoperative Opioid Consumption at 24 Hours

    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.

  2. Time to First Postsurgical Opioid Rescue Medication

    Time frame: 0-48 hours

    Time to first rescue opioid medication used for the treatment of breakthrough pain

  3. Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores

    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').

  4. Number of Participants With Postoperative Nausea and Vomiting

    Time frame: 0-48 hours

    Occurrence of nausea and vomiting 0-48 h after cesarean delivery

  5. Number of Participants With the Need for Rescue Antiemetics

    Time frame: 0-48 hours

    Number of participants who needed medications to treat nausea and vomiting

  6. Number of Participants With Pruritus

    Time frame: 0-48 hours

    Number of participants who complained of pruritus

  7. Number of Participants With the Need for Rescue Antipruritics

    Time frame: 0-48 hours

    Number of participants who needed medications for treatment for pruritus

  8. Number of Participants Not Receiving Any Rescue Opioids Postoperatively

    Time frame: 0-48 hours

    Number of participants who did not need any opioids for break through pain

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Erector Spinae Plane Block With Liposomal Bupivacaine for Post Cesarean Delivery Analgesia: A Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2022
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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