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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03129464
Study type Interventional
Source The Cleveland Clinic
Contact
Status Completed
Phase N/A
Start date February 1, 2017
Completion date July 1, 2018

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