Ice Application for Postoperative Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ice Application for Postoperative Pain: A Randomized Control Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: Ice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Ice<br>Patients will receive standard postoperative pain control methods as defined by the participating institution | |
| Experimental: Ice<br>Patients will receive ice packs to the abdomen, in addition to standard postoperative pain control methods as defined by the participating institution | Other: Ice<br>* ice packs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score of cryotherapy patients as compared to non-cryotherapy patients | 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). | pain score collected at admission to the preoperative holding unit prior to surgery | 
| Pain score of cryotherapy patients as compared to non-cryotherapy patients | 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). | pain score collected immediately after surgery | 
| Pain score of cryotherapy patients as compared to non-cryotherapy patients | 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). | pain score collected post operative day 1 | 
| Pain score of cryotherapy patients as compared to non-cryotherapy patients | 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). | pain score collected at two weeks post operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic usage | Amount of narcotic pain medicines used as measured in morphine milligram equivalent (MME). | postoperative day one | 
| Quality of Recovery (QoR) | 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]. | through study completion to take place at preoperative visit, and post operative day #14. | 
| Time to discharge | Duration of time in minutes between admission to postanesthesia care unit (PACU) and discharge home as recorded in the electronic health record. | day of surgery, up to 1440 minutes |