A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine

Phase 4TerminatedNCT03638011

Maimonides Medical Center71 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Caesarean Section

Interventions

ExparelDRUG

Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Kalpana Tyagaraj

Brooklyn, New York, United States

Maimonides Medical Center

Brooklyn, New York, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Number of Participants Using Narcotics

Total use of narcotics during the post operative period

Time frame: 72 hours

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

Data from ClinicalTrials.gov

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