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NCT00542542 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
A Phase 3 study of Breast Cancer, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
- 1
- Study location
NCT00542542: Completed Phase 3 study of Breast Cancer, sponsored by M.D. Anderson Cancer Center.
NCT00542542 is a Phase 3 study of Breast Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 89 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00542542, a Phase 3 study of Breast Cancer, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia. Secondary Objectives: 1. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia. 2. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative nausea and vomiting in the first 24 hours as compared with patients having only general anesthesia. 3. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in a decreased length of hospital stay compared with patients having only general anesthesia.
Primary Outcome
Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Propofol
- DRUG Ropivacaine
- DRUG Fentanyl
- PROCEDURE Paravertebral Block
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2007-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT00542542 record still lists
NCT00542542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Midazolam is the first listed.
NCT00542542 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00542542 about?
NCT00542542 is a clinical study titled "Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery". Primary Objective: To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia. Secondary Objectives: 1. To determine whether the use ...
What is the current status of trial NCT00542542?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2007-09. Estimated completion is 2014-03.
What conditions does trial NCT00542542 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00542542?
The interventions under investigation include: Midazolam (DRUG), Propofol (DRUG), Ropivacaine (DRUG), Fentanyl (DRUG), Paravertebral Block (PROCEDURE).
Who is sponsoring clinical trial NCT00542542?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00542542 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00542542's enrollment target sits among peer trials
89 622nd of 1224 higher than 601 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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