Caesarean Section
Conditions
Keywords
Cesarean Section, Pregnancy
Brief summary
The primary objective is to reduce or eliminate the use of all narcotics/opiates for post Cesarean section pain management. The investigators hypothesize that in comparison with epidural or intrathecal Duramorph, a TAP block with liposomal bupivacaine (Exparel) will provide better, longer-acting pain control and will significantly reduce the use of post-operative IV or p.o. opiates. This is a prospective, randomized clinical trial.
Detailed description
The investigators will compare the analgesic efficacy and duration of an ultrasound guided bilateral TAP Block (with combined bupivacaine and liposomal bupivacaine) to Duramorph (an opiate). Neuraxial duramorph provides approximately 24 hours of pain relief (analgesia), whereas a bilateral TAP block with liposomal bupivacaine is expected to provide up to 72 hours of analgesia. All participants will have neuraxial anesthesia (either a spinal or epidural) for their non-urgent or elective Cesarean section. The control group (Group 1) will receive either intrathecal or epidural Duramorph (preservative-free morphine sulfate). Post-operatively, participants will have orders to receive, on an as-needed basis, IV/oral acetaminophen and/or IV/oral non-steroidal anti-inflammatory drugs (NSAIDS) for mild-moderate pain, and narcotics for severe pain; specifically- oxycodone or hydromorphone. All patients must receive acetaminophen and NSAIDS (unless contraindicated) before receiving narcotics. This multi-modal pain management regimen is our current standard of care. The experimental group (Group 2) will also receive a spinal or epidural anesthetic. This group will not receive neuraxial Duramorph for post-operative pain. Instead, the patient will receive an ultrasound guided bilateral TAP block with a combination of bupivacaine and liposomal bupivacaine solution immediately after the Cesarean section. Additionally, all participants will receive the same post-operative analgesia orders as group 1.
Interventions
DRUGExparel
Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
Sponsors
Maimonides Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL delivered into the bilateral TAP blocks. TAP blocks are an excellent method for providing adequate analgesia following lower abdominal surgery. Those patients who wish to participate will be asked to sign a study consent form. Patients that decide to participate in this study will be randomized to either group 1 or group 2 (like the flip of a coin). Both groups will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Females, aged 18-45 years inclusive and ASA physical status 1-3. * Undergoing non-urgent Cesarean section with neuraxial anesthesia/analgesia. * Subjects must be physically and mentally able to participate in the study and complete all study assessments. * Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.
Exclusion criteria
History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics * Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a bilateral TAP infiltration. * Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study. * Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of NSAIDs. * Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessed by Visual Analog Scale (VAS) at 48 Hours | 48 hours | To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable). |
| Pain Assessed by Visual Analog Scale (VAS) at 72 Hours | 72 hours | To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Using Narcotics | 72 hours | Total use of narcotics during the post operative period |
| Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale | 72 hours | Patient satisfaction with postsurgical pain management: 0\_\_\_\_\_1\_\_\_\_\_2\_\_\_\_\_3\_\_\_\_\_4\_\_\_\_\_5\_\_\_\_\_6\_\_\_\_\_7\_\_\_\_\_8\_\_\_\_\_9\_\_\_\_\_10 0=not at all satisfied 10= extremely satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain. | 38 |
| Bilateral TAP Block These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia.
Exparel: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL | 33 |
| Total | 71 |
Baseline characteristics
| Characteristic | Bilateral TAP Block | Total | Standard of Care |
|---|---|---|---|
| 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 | 33 Participants | 71 Participants | 38 Participants |
| Age, Continuous | 31.06 years STANDARD_DEVIATION 4.062 | 31.07 years STANDARD_DEVIATION 4.297 | 31.08 years STANDARD_DEVIATION 4.546 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 33 Participants | 71 Participants | 38 Participants |
| Sex: Female, Male Female | 33 Participants | 71 Participants | 38 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 / 38 | 0 / 33 |
| other Total, other adverse events | 0 / 38 | 0 / 33 |
| serious Total, serious adverse events | 0 / 38 | 0 / 33 |
Outcome results
Primary
Pain Assessed by Visual Analog Scale (VAS) at 48 Hours
To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Pain Assessed by Visual Analog Scale (VAS) at 48 Hours | 1.97 units on a scale | Standard Deviation 2.099 |
| Bilateral TAP Block | Pain Assessed by Visual Analog Scale (VAS) at 48 Hours | 1.70 units on a scale | Standard Deviation 2.084 |
Primary
Pain Assessed by Visual Analog Scale (VAS) at 72 Hours
To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Pain Assessed by Visual Analog Scale (VAS) at 72 Hours | 0.67 units on a scale | Standard Deviation 1.531 |
| Bilateral TAP Block | Pain Assessed by Visual Analog Scale (VAS) at 72 Hours | 0.93 units on a scale | Standard Deviation 1.574 |
Secondary
Number of Participants Using Narcotics
Total use of narcotics during the post operative period
Time frame: 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Number of Participants Using Narcotics | 22 participants |
| Bilateral TAP Block | Number of Participants Using Narcotics | 22 participants |
Secondary
Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale
Patient satisfaction with postsurgical pain management: 0\_\_\_\_\_1\_\_\_\_\_2\_\_\_\_\_3\_\_\_\_\_4\_\_\_\_\_5\_\_\_\_\_6\_\_\_\_\_7\_\_\_\_\_8\_\_\_\_\_9\_\_\_\_\_10 0=not at all satisfied 10= extremely satisfied
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale | 9.18 units on a scale | Standard Deviation 0.926 |
| Bilateral TAP Block | Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale | 9.00 units on a scale | Standard Deviation 1.904 |