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NCT04019834 · ClinicalTrials.gov registry record · Early Phase 1
Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy
A Early Phase 1 study of Breast Cancer and Anesthesia, Local, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT04019834: Completed Early Phase 1 study of Breast Cancer and Anesthesia, Local, sponsored by University of Alabama at Birmingham.
NCT04019834 is a Early Phase 1 study of Breast Cancer and Anesthesia, Local that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 21 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04019834, a Early Phase 1 study of Breast Cancer and Anesthesia, Local, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see if pre-operative regional nerve blocks compared to a placebo nerve block can decrease chronic post mastectomy pain, immediate postoperative pain and postoperative narcotic consumption.
Primary Outcome
Severity of postoperative pain will be evaluated by the Brief Pain Inventory- Short Form (BPI-SF). This form asks a series of 9 questions with ratings of pain from 0 (no pain) to 10 (pain as severe as you can imagine) and includes questions evaluating general activities of daily living. The study team will evaluate patient reported levels of pain at 8 hours. This series of questions will be administered in person during the inpatient stay and by telephone or in the clinic setting after discharge
Conditions Studied
Interventions
- DRUG regional nerve block with local anesthesia of bupivacaine with steroid
- OTHER Placebo regional nerveblock with normal saline
Study Locations (1)
Alabama
- University of Alabama at Birmingham Hospitals and Affiliated Clinics - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2021-11-25 |
| Phase | Early Phase 1 |
What the finished NCT04019834 record still lists
NCT04019834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which regional nerve block with local anesthesia of bupivacaine with steroid is the first listed.
NCT04019834 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04019834 about?
NCT04019834 is a clinical study titled "Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy". The purpose of this study is to see if pre-operative regional nerve blocks compared to a placebo nerve block can decrease chronic post mastectomy pain, immediate postoperative pain and postoperative narcotic consumption.
What is the current status of trial NCT04019834?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2020-07-06. Estimated completion is 2021-11-25.
What conditions does trial NCT04019834 study?
This clinical trial studies the following conditions: Breast Cancer, Anesthesia, Local, Mastectomy, Narcotic Use.
What interventions are being tested in trial NCT04019834?
The interventions under investigation include: regional nerve block with local anesthesia of bupivacaine with steroid (DRUG), Placebo regional nerveblock with normal saline (OTHER).
Who is sponsoring clinical trial NCT04019834?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04019834 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT04019834's enrollment target sits among peer trials
21 1073rd of 1224 higher than 147 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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