Clinical Trials Directory

Trials / Completed

CompletedNCT04145791

Ice Application for Postoperative Pain

Ice Application for Postoperative Pain: a Randomized Control Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
74 (actual)
Sponsor
University of Texas Southwestern Medical Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERIceice packs

Timeline

Start date
2019-02-15
Primary completion
2021-02-03
Completion
2021-02-03
First posted
2019-10-31
Last updated
2024-10-29

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04145791. Inclusion in this directory is not an endorsement.