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Opioid Analgesic
Low-Dose vs High-Dose Epidural Morphine for Post-Cesarean Pain Management
Phase < 1
Waitlist Available
Led By Ayodeji Sanusi, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
Awards & highlights
Study Summary
This trial is testing whether a lower dose of morphine given through an epidural decreases side effects, compared to a higher dose.
Who is the study for?
This trial is for women scheduled for cesarean delivery who want a QL block. It's not open to those with insulin-treated diabetes, placental abnormalities, preeclampsia, or a history of opioid use disorder.Check my eligibility
What is being tested?
The study compares two doses of morphine sulfate (50mcg and 150mcg) given epidurally to see if the lower dose can reduce side effects while still providing pain relief after cesarean delivery.See study design
What are the potential side effects?
Possible side effects include nausea, itching, respiratory depression, and delayed bowel function. The aim is to determine whether the lower dose results in fewer or less severe side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one assessment during hospital stay - up to postoperative day 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one assessment during hospital stay - up to postoperative day 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Outcome of side effects of intervention: nausea
Outcome of side effects of intervention: pruritus
Outcome of side effects of intervention: urinary retention
Secondary outcome measures
Maternal from intervention
Neonatal from intervention
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group B: 50 mcg morphineExperimental Treatment1 Intervention
Patients in this group will receive 50mcg of morphine in their neuraxial block
Group II: Group A: 150 mcg morphineActive Control1 Intervention
Patients in this group will receive 150mcg of morphine in their neuraxial block
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,942 Total Patients Enrolled
Ayodeji Sanusi, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Brian Casey, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
1,203 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who have had a pregnancy with preeclampsia complications.Women who are pregnant and need insulin to control their diabetes are not eligible.Women who have pregnancy problems related to the placenta are not eligible.Women who had problems with opioid addiction during their pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Group B: 50 mcg morphine
- Group 2: Group A: 150 mcg morphine
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have further investigations been undertaken to assess the impacts of Morphine Sulfate 50mcg?
"Currently, there are 54 ongoing Morphine Sulfate 50mcg clinical trials. 15 of them have progressed to the final phase and many originated in Boston, Massachusetts; however these studies span 131 medical sites across the United States."
Answered by AI
Are individuals currently able to participate in this clinical research?
"According to clinicaltrials.gov, this trial is enrolling patients now and has seen updates as recent as August 25th 2022. The study was initially posted on September 9th 2020."
Answered by AI
How many individuals are participating in this research endeavor?
"Indeed. Clinicaltrials.gov hosts details that attest to the active recruitment of this trial, which commenced on September 9th 2020. Moreover, 96 participants are needed from one location for the study's completion and it was last updated in August 25th 2022."
Answered by AI
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