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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP Block | Experimental | Standard of care analgesic regimen with ESP Block |
|
| Control | No Intervention | Standard of care analgesic regimen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane (ESP) Block | Procedure | ESP Block with liposomal bupivacaine and immediate release bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Opioid Consumption at 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. | 0-24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf S Habib, MD | Duke University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39981694 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ESP Block | Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side. |
| FG001 | Historical Control | Standard of care analgesic regimen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESP Block | Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery | Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery | Posted | Median | Inter-Quartile Range | mg | 0-48 hours after cesarean delivery |
|
Up to 48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ESP Block | Standard of care analgesic regimen with ESP Block Erector Spinae Plane (ESP) Block: ESP Block with liposomal bupivacaine and immediate release bupivacaine bupivacaine liposome injectable suspension: 133 mg liposomal bupivacaine per side. bupivacaine: 20 ml bupivacaine 0.25% per side. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashraf Haib | Duke Unversity School of Medicine | 919-668-2024 | ashraf.habib@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2024 | Oct 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010268 | Parapsychology |
| D003766 | Dental Occlusion |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
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| bupivacaine liposome injectable suspension | Drug | 133 mg liposomal bupivacaine per side. |
|
| bupivacaine | Drug | 20 ml bupivacaine 0.25% per side. |
|
| Time to First Postsurgical Opioid Rescue Medication | Time to first rescue opioid medication used for the treatment of breakthrough pain | 0-48 hours |
| Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores | 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'). | 0-48 hours |
| Number of Participants With Postoperative Nausea and Vomiting | Occurrence of nausea and vomiting 0-48 h after cesarean delivery | 0-48 hours |
| Number of Participants With the Need for Rescue Antiemetics | Number of participants who needed medications to treat nausea and vomiting | 0-48 hours |
| Number of Participants With Pruritus | Number of participants who complained of pruritus | 0-48 hours |
| Number of Participants With the Need for Rescue Antipruritics | Number of participants who needed medications for treatment for pruritus | 0-48 hours |
| Number of Participants Not Receiving Any Rescue Opioids Postoperatively | Number of participants who did not need any opioids for break through pain | 0-48 hours |
| Historical Control |
Standard of care analgesic regimen |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Postoperative Opioid Consumption at 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. | Posted | Median | Inter-Quartile Range | mg OME | 0-24 hours |
|
|
|
| Secondary | Time to First Postsurgical Opioid Rescue Medication | Time to first rescue opioid medication used for the treatment of breakthrough pain | Posted | Median | Inter-Quartile Range | hours | 0-48 hours |
|
|
|
| Secondary | Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores | 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'). | Posted | Median | Inter-Quartile Range | pain score unit*hours | 0-48 hours |
|
|
|
| Secondary | Number of Participants With Postoperative Nausea and Vomiting | Occurrence of nausea and vomiting 0-48 h after cesarean delivery | Data about postoperative nausea and vomiting not collected on the control group. | Posted | Count of Participants | Participants | 0-48 hours |
|
|
|
| Secondary | Number of Participants With the Need for Rescue Antiemetics | Number of participants who needed medications to treat nausea and vomiting | Posted | Count of Participants | Participants | 0-48 hours |
|
|
|
| Secondary | Number of Participants With Pruritus | Number of participants who complained of pruritus | Data about pruritus not collected on the control group. | Posted | Count of Participants | Participants | 0-48 hours |
|
|
|
| Secondary | Number of Participants With the Need for Rescue Antipruritics | Number of participants who needed medications for treatment for pruritus | Posted | Count of Participants | Participants | 0-48 hours |
|
|
|
| Secondary | Number of Participants Not Receiving Any Rescue Opioids Postoperatively | Number of participants who did not need any opioids for break through pain | Posted | Count of Participants | Participants | 0-48 hours |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | Standard of care analgesic regimen | 0 | 120 | 0 | 120 | 0 | 120 |
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| D055688 | Digestive System and Oral Physiological Phenomena |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |