ESP Block for Post Cesarean Analgesia

NCT05664958 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00112152
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery

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

  0-48 hours after cesarean delivery

Secondary Outcomes (8)

• Postoperative Opioid Consumption at 24 Hours

  0-24 hours

• Time to First Postsurgical Opioid Rescue Medication

  0-48 hours

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

  0-48 hours

• Number of Participants With Postoperative Nausea and Vomiting

  0-48 hours

• Number of Participants With the Need for Rescue Antiemetics

  0-48 hours

Study Arms (2)

ESP Block

EXPERIMENTAL

Standard of care analgesic regimen with ESP Block

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

Control

NO INTERVENTION

Standard of care analgesic regimen

Interventions

Erector Spinae Plane (ESP) Block PROCEDURE

ESP Block with liposomal bupivacaine and immediate release bupivacaine

ESP Block

bupivacaine liposome injectable suspension DRUG

133 mg liposomal bupivacaine per side.

ESP Block

bupivacaine DRUG

20 ml bupivacaine 0.25% per side.

ESP Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ≥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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27701, United States

Location

Related Publications (1)

• Feldman S, Holmes RJ Jr, Fuller M, Habib AS. Erector spinae plane block with liposomal bupivacaine for post-cesarean analgesia. Int J Gynaecol Obstet. 2025 Jul;170(1):489-495. doi: 10.1002/ijgo.70027. Epub 2025 Feb 21.

  PMID: 39981694 DERIVED

MeSH Terms

Interventions

Parapsychology; Dental Occlusion; Bupivacaine

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Ashraf Haib
• Organization: Duke Unversity School of Medicine

ashraf.habib@duke.edu

919-668-2024

Study Officials

• Ashraf S Habib, MD

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 27, 2022
• Study Start: April 17, 2023
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)