Ice Application for Postoperative Pain: a Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 74
- Locations
- 4
- Primary Endpoint
- Pain score of cryotherapy patients as compared to non-cryotherapy patients
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women undergoing laparoscopic hysterectomy for benign indications within 8 weeks of enrollment
- •Women >18 years of age
- •Non-emergent surgery
- •Non-pregnant
- •Women undergoing laparoscopic hysterectomy with the minimally invasive surgery team
Exclusion Criteria
- •Requires surgery for urinary incontinence
- •Has acute angle glaucoma
- •Has severe cardiac/respiratory disease
- •Current chronic pain condition (ie chronic pelvic pain, fibromyalgia, chronic low back pain)
- •Chronic use/abuse of opioid medications for greater than 1 week preceding procedure
- •Chronic NSAID use
- •Current treatment of opioid dependence with methadone or buprenorphine
- •Non-English or Non-Spanish speaking
- •Procedure converted to laparotomy
Outcomes
Primary Outcomes
Pain score of cryotherapy patients as compared to non-cryotherapy patients
Time Frame: pain score collected at two weeks post operative.
To determine if cryotherapy patients will have lower pain scores on a visual analog scale (VAS) compared to standard pain management patients at the time of same day discharge. VAS requires that patients mark their level pain along a straight 100mm line. There are no number markings on the scale. The beginning of the line is labeled on the left as "no pain" and the end of the line on the right is labeled as "worst pain imaginable." Once marked by the patient, the distance from beginning of the line to the patient's hash mark is measured in millimeters and that value is recorded as the pain level. The minimum is 0 (no pain) and the maximum is 100 (worst pain imaginable).
Secondary Outcomes
- Narcotic usage(postoperative day one)
- Time to discharge(day of surgery, up to 1440 minutes)
- Quality of Recovery (QoR)(through study completion to take place at preoperative visit, and post operative day #14.)
Investigators
Kimberly Kho
Associate Professor of Medicine
University of Texas Southwestern Medical Center