Anesthesia
Conditions
Keywords
cesarean delivery, epidural, Neuraxial block, anesthesia side effects
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
Interventions
DRUGMorphine Sulfate 150 mcg
Use of 150mcg of morphine sulfate for neuraxial block (dosing difference)
DRUGMorphine Sulfate 50mcg
Use of 50mcg of morphine sulfate for neuraxial block (dosing difference)
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome of side effects of intervention: pruritus | One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery) | Incidence of primary outcome surrogate marker by need for medication for pruritus based on verbal complaints from patient (Medication given: Yes or No) |
| Outcome of side effects of intervention: nausea | One assessment during hospital stay - up to postoperative day 2 | Incidence of primary outcome surrogate marker by need for medication for nausea based on verbal complaints from patient (Medication given: Yes or No) |
| Outcome of side effects of intervention: urinary retention | One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery) | Incidence of primary outcome surrogate marker by need for removal of foley catheter as measure for urinary retention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal secondary outcomes from intervention | One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery) | Total amount of morphine use during hospital stay (cumulative morphine administered to control pain during hospital stay) |
| Neonatal secondary outcomes from intervention | Within first hour of birth | Apgar scores |
Countries
United States
Outcome results
None listed