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NCT01739699 · ClinicalTrials.gov registry record · Phase 4
The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period
A Phase 4 study of Craniotomy and Brain Surgery, sponsored by Endeavor Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT01739699: Completed Phase 4 study of Craniotomy and Brain Surgery, sponsored by Endeavor Health.
NCT01739699 is a Phase 4 study of Craniotomy and Brain Surgery that has completed, run by Endeavor Health. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01739699, a Phase 4 study of Craniotomy and Brain Surgery, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned. The following general perioperative data will be recorded: patient information/preoperative data, procedural information, postoperative information, and overall satisfaction of pain management at 24 hours after surgery. Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.
Primary Outcome
The purpose of the study was to determine whether more patients undergoing craniotomies would not require any opioids (i.e., opioid consumption reduced to zero) during the first 24 postoperative hours when receiving intravenous (IV) acetaminophen during that time compared to those receiving placebo (normal saline).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acetaminophen
Study Locations (1)
Illinois
- NorthShore University HealthSystem - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2012-01 |
| Est. Completion | 2017-01-20 |
| Phase | Phase 4 |
What the finished NCT01739699 record still lists
NCT01739699 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Craniotomy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01739699 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01739699 about?
NCT01739699 is a clinical study titled "The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period". This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetamin...
What is the current status of trial NCT01739699?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2012-01. Estimated completion is 2017-01-20.
What conditions does trial NCT01739699 study?
This clinical trial studies the following conditions: Craniotomy, Brain Surgery.
What interventions are being tested in trial NCT01739699?
The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT01739699?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01739699 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01739699's enrollment target sits among peer trials
140 581st of 2000 higher than 1,409 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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