Cesarean Section Complications
Conditions
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.
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.
Interventions
PROCEDUREErector Spinae Plane (ESP) Block
ESP Block with liposomal bupivacaine and immediate release bupivacaine
133 mg liposomal bupivacaine per side.
DRUGbupivacaine
20 ml bupivacaine 0.25% per side.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery | 0-48 hours after cesarean delivery | Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Postsurgical Opioid Rescue Medication | 0-48 hours | Time to first rescue opioid medication used for the treatment of breakthrough pain |
| Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores | 0-48 hours | 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'). |
| Number of Participants With Postoperative Nausea and Vomiting | 0-48 hours | Occurrence of nausea and vomiting 0-48 h after cesarean delivery |
| Postoperative Opioid Consumption at 24 Hours | 0-24 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. |
| Number of Participants With Pruritus | 0-48 hours | Number of participants who complained of pruritus |
| Number of Participants With the Need for Rescue Antipruritics | 0-48 hours | Number of participants who needed medications for treatment for pruritus |
| Number of Participants Not Receiving Any Rescue Opioids Postoperatively | 0-48 hours | Number of participants who did not need any opioids for break through pain |
| Number of Participants With the Need for Rescue Antiemetics | 0-48 hours | Number of participants who needed medications to treat nausea and vomiting |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Historical Control Standard of care analgesic regimen | 120 |
| Total | 150 |
Baseline characteristics
| Characteristic | Historical Control | Total | ESP Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants | 150 Participants | 30 Participants |
| Age, Continuous | 33 years | 33 years | 33 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 20 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 10 Participants | 2 Participants |
| Race (NIH/OMB) White | 92 Participants | 115 Participants | 23 Participants |
| Region of Enrollment United States | 120 Participants | 150 Participants | 30 Participants |
| Sex: Female, Male Female | 120 Participants | 150 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 120 |
| other Total, other adverse events | 0 / 30 | 0 / 120 |
| serious Total, serious adverse events | 0 / 30 | 0 / 120 |
Outcome results
Primary
Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery
Total dose of rescue oxycodone used in mg 0- 48 hours after cesarean delivery
Time frame: 0-48 hours after cesarean delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ESP Block | Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery | 12.5 mg |
| Historical Control | Postoperative Oxycodone Consumption 0- 48 Hours After Cesarean Delivery | 25 mg |
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').
Time frame: 0-48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ESP Block | Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores | 115 pain score unit*hours |
| Historical Control | Area Under the Curve (AUC) of Verbal Rating Scale (VRS) Pain Intensity Scores | 140 pain score unit*hours |
Secondary
Number of Participants Not Receiving Any Rescue Opioids Postoperatively
Number of participants who did not need any opioids for break through pain
Time frame: 0-48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESP Block | Number of Participants Not Receiving Any Rescue Opioids Postoperatively | 6 Participants |
| Historical Control | Number of Participants Not Receiving Any Rescue Opioids Postoperatively | 27 Participants |
Secondary
Number of Participants With Postoperative Nausea and Vomiting
Occurrence of nausea and vomiting 0-48 h after cesarean delivery
Time frame: 0-48 hours
Population: Data about postoperative nausea and vomiting not collected on the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESP Block | Number of Participants With Postoperative Nausea and Vomiting | 12 Participants |
Secondary
Number of Participants With Pruritus
Number of participants who complained of pruritus
Time frame: 0-48 hours
Population: Data about pruritus not collected on the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESP Block | Number of Participants With Pruritus | 21 Participants |
Secondary
Number of Participants With the Need for Rescue Antiemetics
Number of participants who needed medications to treat nausea and vomiting
Time frame: 0-48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESP Block | Number of Participants With the Need for Rescue Antiemetics | 8 Participants |
| Historical Control | Number of Participants With the Need for Rescue Antiemetics | 48 Participants |
Secondary
Number of Participants With the Need for Rescue Antipruritics
Number of participants who needed medications for treatment for pruritus
Time frame: 0-48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESP Block | Number of Participants With the Need for Rescue Antipruritics | 5 Participants |
| Historical Control | Number of Participants With the Need for Rescue Antipruritics | 30 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.
Time frame: 0-24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ESP Block | Postoperative Opioid Consumption at 24 Hours | 7.5 mg OME |
| Historical Control | Postoperative Opioid Consumption at 24 Hours | 15 mg OME |
Secondary
Time to First Postsurgical Opioid Rescue Medication
Time to first rescue opioid medication used for the treatment of breakthrough pain
Time frame: 0-48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ESP Block | Time to First Postsurgical Opioid Rescue Medication | 12.2 hours |
| Historical Control | Time to First Postsurgical Opioid Rescue Medication | 3.2 hours |