Postoperative Pain
Conditions
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. 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.
Interventions
OTHERIce
ice packs
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score of cryotherapy patients as compared to non-cryotherapy patients | pain score collected at admission to the preoperative holding unit prior to surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Narcotic usage | postoperative day one | Amount of narcotic pain medicines used as measured in morphine milligram equivalent (MME). |
| Quality of Recovery (QoR) | through study completion to take place at preoperative visit, and post operative day #14. | Return to baseline activity as measured by QoR questionnaire. The questionnaire consists of 15 items, 10 in Part A and 5 in Part B. Part A assesses patients daily functioning and utilizes a Likert scale 0 to 10, where 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]. Park B asses symptomatology and utilizes a Likert scale (0 to 10, where 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]. |
| Time to discharge | day of surgery, up to 1440 minutes | Duration of time in minutes between admission to postanesthesia care unit (PACU) and discharge home as recorded in the electronic health record. |
Countries
United States
Outcome results
None listed