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NCT03027661 · ClinicalTrials.gov registry record · Phase 3
Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain.
A Phase 3 study of Pain, Postoperative, sponsored by University of Tennessee.
- Completed
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT03027661 is a Phase 3 study of Pain, Postoperative that has completed, run by University of Tennessee. The registered enrollment target is 41 participants, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03027661, a Phase 3 study of Pain, Postoperative, has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective randomized controlled trial in which patients that are scheduled to undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using block randomization. The intervention would be performed after the patient is under general anesthesia, prior to starting the surgery. Patients would be consented in the office or preoperative area (before receiving sedatives). As far as the intervention itself, it would consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock, which is standard technique for para-cervical block. The remainder of the procedure will then continue in a regular fashion. Alternatively, patients in the control group will be injected with 5 mL of normal saline. The surgeon would be blinded as to patient allocation. Research staff will have previously prepared the formulations (saline or bupivacaine) and have sent them to the operating room prior to beginning the procedure depending on assigned group. At the end of the case, pain will be assessed using a visual analogue scale with a range from 0 to 10 by one of the researches who will also be blinded to the group. This will be done at 30 and 60 minutes after surgical stop time. Additional pain control in the postanesthesia care unit (PACU) will be standardized to all patients. Hypothesis: Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy significantly reduces pain after the procedure
Conditions Studied
Interventions
- DRUG Bupivacaine
- DRUG 0.9% Sodium Chloride
Study Locations (1)
Tennessee
- Erlanger Medical Center - Chattanooga
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2018-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03027661
The ClinicalTrials.gov registry entry for NCT03027661 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (85% lower). The listed sponsor is University of Tennessee, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine is the first listed.
NCT03027661 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT03027661 about?
NCT03027661 is a clinical study titled "Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain.". This is a prospective randomized controlled trial in which patients that are scheduled to undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using block randomization. The interv...
What is the current status of trial NCT03027661?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2017-08-01. Estimated completion is 2018-06-30.
What conditions does trial NCT03027661 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT03027661?
The interventions under investigation include: Bupivacaine (DRUG), 0.9% Sodium Chloride (DRUG).
Who is sponsoring clinical trial NCT03027661?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03027661 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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