ESP Block for Post Cesarean Analgesia

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05664958
• Other study ID #: Pro00112152
• Status: Completed
• Phase: Phase 4
• Start date: April 17, 2023
• Est. completion date: November 9, 2023

Study information

• Verified date: April 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• Erector Spinae Plane (ESP) Block
ESP Block with liposomal bupivacaine and immediate release bupivacaine

Drug:
• bupivacaine liposome injectable suspension
133 mg liposomal bupivacaine per side.
• bupivacaine
20 ml bupivacaine 0.25% per side.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative oxycodone consumption 0- 48 hours after cesarean delivery	Total dose of rescue oxycodone used	0-48 hours after cesarean delivery
Secondary	Postoperative opioid consumption at 24 hours	Total dose of rescue opioids used	0-24 hours
Secondary	Time to first postsurgical opioid rescue medication	Time to first rescue opioid	0-48 hours
Secondary	Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores	Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores	0-48 hours
Secondary	Postoperative nausea and vomiting	Occurrence of nausea and vomiting	0-48 hours
Secondary	Need for rescue antiemetics	Need for medications to treat nausea and vomiting	0-48 hours
Secondary	Pruritus	Occurrence of pruritus	0-48 hours
Secondary	Need for rescue antipruritics	Need for treatment for pruritus	0-48 hours
Secondary	Proportion of opioids free patients	Proportion of patients not receiving any rescue opioids postoperatively.	0-48 hours