Skip to main content
OpenTrials
Completed

NCT Number: NCT04279054

Decreased Neuraxial Morphine After Cesarean Delivery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

UAB Women and Infants Center

Birmingham, Alabama, 35233, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine Sulfate 150 mcg

Drug

Use of 150mcg of morphine sulfate for neuraxial block (dosing difference)

Morphine Sulfate 50mcg

Drug

Use of 50mcg of morphine sulfate for neuraxial block (dosing difference)

Primary outcomes

  1. Outcome of side effects of intervention: pruritus

    Time frame: 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)

  2. Outcome of side effects of intervention: nausea

    Time frame: 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)

  3. Outcome of side effects of intervention: urinary retention

    Time frame: 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 outcomes

  1. Maternal secondary outcomes from intervention

    Time frame: 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)

  2. Maternal secondary outcomes from intervention

    Time frame: One measurement during entire hospital stay

    Incidence of daily pain scores (measured by pain score ratings: 1-10); 1: lowest pain score 10: maximum pain score

  3. Neonatal secondary outcomes from intervention

    Time frame: Within first hour of birth

    Apgar scores

  4. Neonatal secondary outcomes from intervention

    Time frame: Within first hour of birth

    Incidence of babies with signs of respiratory depression

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Decreased Neuraxial Morphine and Adjunctive Peripheral Nerve Blockade to Reduce Severity of Side Effects and Opioid Use After Cesarean Delivery

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2020
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.