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NCT02009722 · ClinicalTrials.gov registry record · Phase 4
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
A Phase 4 study of Cesarean Section and Analgesia, Obstetrical, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT02009722: Completed Phase 4 study of Cesarean Section and Analgesia, Obstetrical, sponsored by Mayo Clinic.
NCT02009722 is a Phase 4 study of Cesarean Section and Analgesia, Obstetrical that has completed, run by Mayo Clinic. The registered enrollment target is 84 participants, below the 164-participant average among 14 other Cesarean Section trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02009722, a Phase 4 study of Cesarean Section and Analgesia, Obstetrical, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery. In this study, the investigators are going to determine the doses of each of those medicines that provides optimal pain control to women undergoing cesarean delivery while limiting side effects related to those medicines. The investigators hypothesize that the doses of hydromorphone and morphine that provide optimal pain control without significant side effects will be 100 micrograms and 150 micrograms, respectively. The investigators further hypothesize that at each respective optimal dose, side effects will be less in the hydromorphone group.
Primary Outcome
Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score \<4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients
Conditions Studied
Interventions
- DRUG Hydromorphone
- DRUG Morphine
Study Locations (1)
Minnesota
- Rochester Methodist Hospital, Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-04 |
| Phase | Phase 4 |
What the finished NCT02009722 record still lists
NCT02009722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 164-participant average among 14 other Cesarean Section trials with a reported enrollment target (49% lower).
The record links to 2 conditions, with Cesarean Section appearing as the primary indexed condition, and to 2 interventions - of which Hydromorphone is the first listed.
NCT02009722 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02009722 about?
NCT02009722 is a clinical study titled "Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose". Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery. In this study, the investigators are going to determine the doses of each of those medicines that provides optimal pain control to women undergoing cesarean delivery wh...
What is the current status of trial NCT02009722?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2014-01. Estimated completion is 2015-04.
What conditions does trial NCT02009722 study?
This clinical trial studies the following conditions: Cesarean Section, Analgesia, Obstetrical.
What interventions are being tested in trial NCT02009722?
The interventions under investigation include: Hydromorphone (DRUG), Morphine (DRUG).
Who is sponsoring clinical trial NCT02009722?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02009722 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cesarean Section
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02009722's enrollment target sits among peer trials
84 10th of 14 higher than 5 of 14 other Cesarean Section trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cesarean Section 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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