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NCT03129464 · ClinicalTrials.gov registry record · NA
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management
A NA study of Pain, Postoperative, sponsored by Cleveland Clinic Florida.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT03129464: Completed NA study of Pain, Postoperative, sponsored by Cleveland Clinic Florida.
NCT03129464 is a NA study of Pain, Postoperative that has completed, run by Cleveland Clinic Florida. The registered enrollment target is 56 participants, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03129464, a NA study of Pain, Postoperative, has completed, sponsored by Cleveland Clinic Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. After surgery is completed participants will be randomized to either the control group or the study group. The study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. Investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores. This study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. Investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.
Primary Outcome
Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable.
Conditions Studied
Interventions
- DEVICE Cold therapy via reusable cold gel pack
Study Locations (1)
Florida
- Cleveland Clinic Florida - Weston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2018-07-01 |
| Phase | NA |
What the finished NCT03129464 record still lists
NCT03129464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 1 intervention - of which Cold therapy via reusable cold gel pack is the first listed.
NCT03129464 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03129464 about?
NCT03129464 is a clinical study titled "Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management". This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without...
What is the current status of trial NCT03129464?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2017-02-01. Estimated completion is 2018-07-01.
What conditions does trial NCT03129464 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT03129464?
The interventions under investigation include: Cold therapy via reusable cold gel pack (DEVICE).
Who is sponsoring clinical trial NCT03129464?
This trial is sponsored by Cleveland Clinic Florida, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03129464 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03129464's enrollment target sits among peer trials
56 86th of 113 higher than 27 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative 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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