Decreased Neuraxial Morphine After Cesarean Delivery

The University of Alabama at Birmingham

Status and phase: Completed; Early Phase 1

Conditions: Anesthesia

Treatments: Drug: Morphine Sulfate 50mcg; Drug: Morphine Sulfate 150 mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT04279054

UL1TR003096 (U.S. NIH Grant/Contract)

IRB00000196

Details and patient eligibility

About

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

Full 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

Enrollment: 87 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups

Group A: 150 mcg morphine

Active Comparator group

Description:

Patients in this group will receive 150mcg of morphine in their neuraxial block

Treatment:

Drug: Morphine Sulfate 150 mcg

Group B: 50 mcg morphine

Experimental group

Description:

Patients in this group will receive 50mcg of morphine in their neuraxial block

Treatment:

Drug: Morphine Sulfate 50mcg