A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/31/2019 |
| Start Date: | September 25, 2018 |
| End Date: | August 1, 2021 |
| Contact: | Dennis E Feierman, PhD, MD |
| Email: | dfeierman@maimonidesmed.org |
| Phone: | 781283-7611 |
A Comparison of the Post-cesarean Section Analgesic Effects of Neuraxial Duramorph vs. Bilateral Transverse Abdominal Plane Block With Combined Bupivacaine/Liposomal Bupivacaine (Exparel)
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.
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.
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.
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.
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.
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