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Opioid Analgesic
Intrathecal Morphine Doses for Post-Cesarean Pain Management
Phase < 1
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Parturient 18 years of age or older
Undergoing elective cesarean delivery under spinal anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 48 hours
Awards & highlights
Study Summary
This trial is testing what is the ideal amount of morphine to use in spinal anesthesia for those undergoing c-section. They will be comparing a lower dose to the standard amount to see if there are any differences in postoperative pain relief or side effects.
Who is the study for?
This trial is for women over 18 years old who are having a planned cesarean section with spinal anesthesia. They must be able to give consent and follow up after the surgery. Women can't join if they have urgent cases, bleeding disorders, certain enzyme deficiencies, liver or kidney diseases, platelet issues, drug allergies related to the study, substance abuse problems, chronic pain or narcotic use.Check my eligibility
What is being tested?
The study aims to find the best dose of spinal morphine for pain relief after a cesarean section. Participants will be split into two groups: one receiving a standard dose (0.1mg) and another getting a lower dose (0.05mg) of intrathecal morphine along with other pain medications like bupivacaine and fentanyl.See study design
What are the potential side effects?
Possible side effects from spinal morphine include nausea and itching; however, it's thought that these might be less common with the lower dose being tested against the standard dose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am pregnant and 18 years or older.
Select...
I am scheduled for a C-section with spinal anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 and 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first narcotic rescue dose in the first 24 hours posto cesarean delivery.
Secondary outcome measures
opiate consumption
overall patient satisfaction with pain control
presence of opiate side effects (nausea, vomiting, and pruritus)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: recieving 0.05 mg IT morphineExperimental Treatment1 Intervention
Patients will receive 0.05 mg of intrathecal morphine
Group II: receiving 0.1 mg IT morphineActive Control1 Intervention
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
recieving 0.05 mg IT morphine
2018
Completed Early Phase 1
~200
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,060 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of alcohol abuse or dependency.You are allergic to any of the medications being used in the study.I am pregnant and 18 years or older.I am scheduled for a C-section with spinal anesthesia.You use illegal drugs.I have had or currently have bleeding in my stomach or intestines.I have a bleeding disorder or a condition affecting blood clotting.I have been diagnosed with G6PD deficiency.I have kidney problems.I cannot or will not have a spinal anesthetic.I have a liver condition.I will undergo surgery with general anesthesia.I experience chronic pain.You are allergic to morphine.You regularly use narcotics for a long time.
Research Study Groups:
This trial has the following groups:- Group 1: receiving 0.1 mg IT morphine
- Group 2: recieving 0.05 mg IT morphine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any opportunities to participate in this experiment at present?
"All indications from clinicaltrials.gov point to the fact that this research is actively recruiting patients, with a commencement date of January 16th 2018 and last update on March 15th 2022."
Answered by AI
How many people are eligible to participate in this scientific experiment?
"Affirmative. Clinicaltrials.gov's records indicate that this medical trial is actively looking for participants, beginning with the 16th of January 2018 and most recently modified on March 15th 2022. The study seeks to enrol 200 patients at a single site."
Answered by AI
Has any prior research been conducted in regards to the administration of 0.05 mg IT morphine?
"Currently, 54 clinical trials are underway to evaluate the effects of 0.05 mg IT morphine. 15 of these studies have reached Phase 3 and 131 sites across the U.S., with a concentration in Boston, Massachusetts, are participating in this research effort."
Answered by AI
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