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NCT03427463 · ClinicalTrials.gov registry record · Early Phase 1
Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 229
- Enrollment target
NCT03427463 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 229 participants.
The verdict
NCT03427463, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 229 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.
Interventions
- DRUG receiving 0.1 mg IT morphine
- DRUG recieving 0.05 mg IT morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2018-01-16 |
| Est. Completion | 2023-08-03 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03427463
The ClinicalTrials.gov registry entry for NCT03427463 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which receiving 0.1 mg IT morphine is the first listed.
NCT03427463 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03427463 about?
NCT03427463 is a clinical study titled "Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.". The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding...
What is the current status of trial NCT03427463?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 229 participants. The study started on 2018-01-16. Estimated completion is 2023-08-03.
What interventions are being tested in trial NCT03427463?
The interventions under investigation include: receiving 0.1 mg IT morphine (DRUG), recieving 0.05 mg IT morphine (DRUG).
Who is sponsoring clinical trial NCT03427463?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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