Decreased Neuraxial Morphine After Cesarean Delivery

March 29, 2024 updated by: Ayodeji Sanusi, University of Alabama at Birmingham

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Women and Infants Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: 150 mcg morphine
Patients in this group will receive 150mcg of morphine in their neuraxial block
Drug: Morphine Sulfate 150 mcg
Use of 150mcg of morphine sulfate for neuraxial block (dosing difference)
Experimental: Group B: 50 mcg morphine
Patients in this group will receive 50mcg of morphine in their neuraxial block
Drug: Morphine Sulfate 50mcg
Use of 50mcg of morphine sulfate for neuraxial block (dosing difference)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
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)
One assessment during hospital stay - up to postoperative day 2
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
One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
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
One measurement during entire hospital stay
Neonatal secondary outcomes from intervention
Time Frame: Within first hour of birth
Apgar scores
Within first hour of birth
Neonatal secondary outcomes from intervention
Time Frame: Within first hour of birth
Incidence of babies with signs of respiratory depression
Within first hour of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Ayodeji Sanusi, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2020

Primary Completion (Actual)

July 5, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00000196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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