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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: Completed Early Phase 1 study, sponsored by Medical University of South Carolina.
NCT03427463 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 229 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (332% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.
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 |
What the finished NCT03427463 record still lists
NCT03427463 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (332% higher).
The record links to 0 conditions, and to 2 interventions - of which receiving 0.1 mg IT morphine is the first listed.
NCT03427463 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03427463's enrollment target sits among peer trials
229 53rd of 2000 higher than 1,948 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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