ESP Block for Post Cesarean Analgesia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ESP Block Standard of care analgesic regimen with ESP Block |
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.
Drug: bupivacaine
20 ml bupivacaine 0.25% per side.
|
| No Intervention: Control Standard of care analgesic regimen |
Outcome Measures
Primary Outcome Measures
- Postoperative oxycodone consumption 0- 48 hours after cesarean delivery [0-48 hours after cesarean delivery]
Total dose of rescue oxycodone used
Secondary Outcome Measures
- Postoperative opioid consumption at 24 hours [0-24 hours]
Total dose of rescue opioids used
- Time to first postsurgical opioid rescue medication [0-48 hours]
Time to first rescue opioid
- Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores [0-48 hours]
Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores
- Postoperative nausea and vomiting [0-48 hours]
Occurrence of nausea and vomiting
- Need for rescue antiemetics [0-48 hours]
Need for medications to treat nausea and vomiting
- Pruritus [0-48 hours]
Occurrence of pruritus
- Need for rescue antipruritics [0-48 hours]
Need for treatment for pruritus
- Proportion of opioids free patients [0-48 hours]
Proportion of patients not receiving any rescue opioids postoperatively.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Hospital | Durham | North Carolina | United States | 27701 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Ashraf S Habib, MD, Duke University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00112152