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Ice Application for Postoperative Pain (Ice-POP)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ice
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Parkland Health and Hospital System
  • Clements University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Ice

Ice

Arm Description

Patients will receive standard postoperative pain control methods as defined by the participating institution

Patients will receive ice packs to the abdomen, in addition to standard postoperative pain control methods as defined by the participating institution

Outcomes

Primary Outcome Measures

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 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 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 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).

Secondary Outcome Measures

Narcotic usage
Amount of narcotic pain medicines used as measured in morphine milligram equivalent (MME).
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].
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.

Full Information

First Posted
March 1, 2019
Last Updated
February 24, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04145791
Brief Title
Ice Application for Postoperative Pain
Acronym
Ice-POP
Official Title
Ice Application for Postoperative Pain: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
February 3, 2021 (Actual)
Study Completion Date
February 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Ice
Arm Type
No Intervention
Arm Description
Patients will receive standard postoperative pain control methods as defined by the participating institution
Arm Title
Ice
Arm Type
Experimental
Arm Description
Patients will receive ice packs to the abdomen, in addition to standard postoperative pain control methods as defined by the participating institution
Intervention Type
Other
Intervention Name(s)
Ice
Intervention Description
ice packs
Primary Outcome Measure Information:
Title
Pain score of cryotherapy patients as compared to non-cryotherapy patients
Description
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).
Time Frame
pain score collected at admission to the preoperative holding unit prior to surgery
Title
Pain score of cryotherapy patients as compared to non-cryotherapy patients
Description
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).
Time Frame
pain score collected immediately after surgery
Title
Pain score of cryotherapy patients as compared to non-cryotherapy patients
Description
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).
Time Frame
pain score collected post operative day 1
Title
Pain score of cryotherapy patients as compared to non-cryotherapy patients
Description
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).
Time Frame
pain score collected at two weeks post operative.
Secondary Outcome Measure Information:
Title
Narcotic usage
Description
Amount of narcotic pain medicines used as measured in morphine milligram equivalent (MME).
Time Frame
postoperative day one
Title
Quality of Recovery (QoR)
Description
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 Frame
through study completion to take place at preoperative visit, and post operative day #14.
Title
Time to discharge
Description
Duration of time in minutes between admission to postanesthesia care unit (PACU) and discharge home as recorded in the electronic health record.
Time Frame
day of surgery, up to 1440 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Kho, MD
Organizational Affiliation
University of Texas as Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Clements University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ice Application for Postoperative Pain

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