Cesarean Section ComplicationsPhase 4NCT05664958
ESP Block for Post Cesarean Analgesia
A Phase 4 study testing Erector Spinae Plane (ESP) Block, bupivacaine liposome injectable suspension and bupivacaine in people with Cesarean Section Complications, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Erector Spinae Plane (ESP) Block, bupivacaine liposome injectable suspension and bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 9 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ≥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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27701
About this study
Official title: Erector Spinae Plane Block With Liposomal Bupivacaine for Post Cesarean Delivery Analgesia: A Pilot Study
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.
Read the 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.
- Conditions
- Cesarean Section Complications
- Being tested
- Erector Spinae Plane (ESP) Block, bupivacaine liposome injectable suspension, bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane (ESP) BlockProcedure or surgery
ESP Block with liposomal bupivacaine and immediate release bupivacaine
bupivacaine liposome injectable suspensionDrug
133 mg liposomal bupivacaine per side.
bupivacaineDrug
20 ml bupivacaine 0.25% per side.
| Study group | Role | What they receive |
|---|---|---|
| ESP Block | Experimental | Standard of care analgesic regimen with ESP Block Receives: Procedure: Erector Spinae Plane (ESP) Block; Drug: bupivacaine liposome injectable suspension; Drug: bupivacaine |
| Control | No intervention | Standard of care analgesic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery
Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery
Measured: 0-48 hours after cesarean delivery
Secondary outcomes (8)
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.
Measured: 0-24 hours
Time to First Postsurgical Opioid Rescue Medication
Time to first rescue opioid medication used for the treatment of breakthrough pain
Measured: 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').
Measured: 0-48 hours
Number of Participants With Postoperative Nausea and Vomiting
Occurrence of nausea and vomiting 0-48 h after cesarean delivery
Measured: 0-48 hours
Number of Participants With the Need for Rescue Antiemetics
Number of participants who needed medications to treat nausea and vomiting
Measured: 0-48 hours
Number of Participants With Pruritus
Number of participants who complained of pruritus
Measured: 0-48 hours
Number of Participants With the Need for Rescue Antipruritics
Number of participants who needed medications for treatment for pruritus
Measured: 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
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start17 Apr 2023
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf S Habib, MD, Principal investigator, Duke University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664958
- Sponsor's protocol ID
- Pro00112152
- Status last verified
- Feb 2025
- First submitted
- 9 Dec 2022
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39981694
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block With Liposomal Bupivacaine for Post Cesarean Delivery Analgesia: A Pilot Study
- ClinicalTrials.gov ID
- NCT05664958
- Acronym / sponsor ID
- Pro00112152
- Conditions
- Cesarean Section Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Block | Experimental | Procedure: Erector Spinae Plane (ESP) Block, Drug: bupivacaine liposome injectable suspension, Drug: bupivacaineStandard of care analgesic regimen with ESP Block |
| Control | No intervention | –Standard of care analgesic regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- ≥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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane (ESP) BlockESP Block with liposomal bupivacaine and immediate release bupivacaine | Procedure or surgery | ESP Block |
| bupivacaine liposome injectable suspension133 mg liposomal bupivacaine per side. | Drug | ESP Block |
| bupivacaine20 ml bupivacaine 0.25% per side. | Drug | ESP Block |
Primary outcome
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
8 secondary outcomes
Postoperative Opioid Consumption at 24 Hours
Time frame: 0-24 hours
Time to First Postsurgical Opioid Rescue Medication
Time frame: 0-48 hours
Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores
Time frame: 0-48 hours
Number of Participants With Postoperative Nausea and Vomiting
Time frame: 0-48 hours
Number of Participants With the Need for Rescue Antiemetics
Time frame: 0-48 hours
Number of Participants With Pruritus
Time frame: 0-48 hours
Number of Participants With the Need for Rescue Antipruritics
Time frame: 0-48 hours
Number of Participants Not Receiving Any Rescue Opioids Postoperatively
Time frame: 0-48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39981694Feldman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf S Habib, MD principal investigator
Duke University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector Spinae Plane (ESP) Block, bupivacaine liposome injectable suspension and bupivacaine in people with Cesarean Section Complications, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery (time frame: 0-48 hours after cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05664958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.