Clinical trial NCT04279054: Decreased Neuraxial Morphine After Cesarean Delivery
Official title: Decreased Neuraxial Morphine and Adjunctive Peripheral Nerve Blockade to Reduce Severity of Side Effects and Opioid Use After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anesthesia
Keywords: cesarean delivery
epidural
Neuraxial block
anesthesia side effects
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 87
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare 50mcg to 150mcg morphine in epidural for the goal of decreasing side effects of medication with lower dose in patients who receive a QL block

Detailed description: Regional anesthesia has been associated with reduced opioid consumption after surgery. Cesarean delivery is one of the most commonly performed surgeries worldwide and women undergoing cesarean delivery are often young, opioid-naïve, and motivated to recover quickly in an effort to better care for their newborn. However, approximately 1 in 300 opioid naïve women become persistent prescription opioid users following cesarean delivery . Hence, it is important to optimize post-cesarean pain control while limiting exposure to opioids. Currently, standard therapy includes the use of neuraxial morphine (NM) in combination with a multi-modal regime in an effort to limit excessive opioid use after cesarean delivery. The current typical dose of NM that is given prior to cesarean delivery at the investigator's center is 150 mcg. Importantly, NM doses as low as 100 mcg have been shown to provide comparable analgesia while reducing side effects such as itching. The side-effect profile associated with NM includes up to 87% of patients experiencing pruritus and up to 70% experiencing urinary retention. Nausea and vomiting also lead to significant discomfort for a new mother trying to provide acute infant care.

Adjunctive Peripheral Nerve Blockade has recently been introduced to reduce postoperative pain and opioid use. Studies have assessed the usefulness of the transversus abdmoninis plane (TAP) block after cesarean delivery. Another ultrasound-guided injection of local anesthetic in the fascial plane (truncal block) that is available at UAB and within the standard of care for patients undergoing abdominal surgery is the quadratus lumborum (QL) block. Because of its more posterior and caudal location, it is more likely to anesthetize the nerve fibers associated with pain from cesarean delivery.

This study will compare the use of 50mcg to 150mcg morphine for the goal of decreasing side effects of medication with lower dose in all patients who receive a QL block

Eligibility criteria: Inclusion Criteria:

* All women presenting for scheduled cesarean delivery who desire a QL block

Exclusion Criteria:

* Women with pregnancies complicated by preeclampsia
* Women with pregnancies complicated by insulin-treated diabetes
* Women with pregnancies complicated by placental abnormalities
* Women with pregnancies complicated by a history of opioid use disorder

Primary outcomes:
measure: Outcome of side effects of intervention: pruritus
timeFrame: One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
measure: Outcome of side effects of intervention: nausea
timeFrame: One assessment during hospital stay - up to postoperative day 2
measure: Outcome of side effects of intervention: urinary retention
timeFrame: One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
Secondary outcomes:
measure: Maternal secondary outcomes from intervention
timeFrame: One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
measure: Maternal secondary outcomes from intervention
timeFrame: One measurement during entire hospital stay
measure: Neonatal secondary outcomes from intervention
timeFrame: Within first hour of birth
measure: Neonatal secondary outcomes from intervention
timeFrame: Within first hour of birth
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Women and Infants Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ayodeji Sanusi, MD
role: PRINCIPAL_INVESTIGATOR
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