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Clinical Trial Summary

The purpose of the proposed study is to investigate the effectiveness of cryotherapy as an additional form of pain control in women undergoing laparoscopic hysterectomy for benign gynecologic conditions through a randomized trial.


Clinical Trial Description

The purpose of the proposed study is to investigate the effectiveness of cryotherapy as an additional form of pain control in women undergoing laparoscopic hysterectomy for benign gynecologic conditions through a randomized trial. The following aims will be pursued: Primary Aim: To determine if cryotherapy patients will have lower pain scores on VAS compared to standard pain management patients. Primary Hypothesis: Patients receiving cryotherapy will have lower VAS scores compared to patients receiving pain management. Secondary Aim 1: To determine if cryotherapy will reduce the number of morphine milligram equivalent (MME) compared to patients with standard pain management. Secondary Hypothesis 1: Patients receiving cryotherapy will have lower MME values compared to patients with standard pain management. Secondary Aim 2: To determine if cryotherapy will result in earlier return to baseline activity as measured by Quality of Recovery Questionnaire (QoR). Secondary Hypothesis 2: Patients receiving cryotherapy will return to baseline activity level sooner than those receiving standard pain management. Secondary Aim 3: To determine if cryotherapy will result in a faster time to discharge as determined by duration between admission to postanesthesia care unit (PACU) and discharge home. Secondary Hypothesis 3: Patient receiving cryotherapy will be have a shorter stay in PACU. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04145791
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase N/A
Start date February 15, 2019
Completion date February 3, 2021

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