Postoperative PainIce-POPNCT04145791
Ice Application for Postoperative Pain
A study testing Ice in people with Postoperative Pain, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2019to 3 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Current treatment of opioid dependence with methadone or buprenorphine
- Non-English or Non-Spanish speaking
- Procedure converted to laparotomy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkland Health and Hospital System
Dallas, Texas, 75235
Clements University Hospital
Dallas, Texas, 75390
About this study
Official title: Ice Application for Postoperative Pain: a Randomized Control Trial
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.
Read the 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
- Postoperative Pain
- Being tested
- Ice
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IceOther
ice packs
| Study group | Role | What they receive |
|---|---|---|
| No Ice | No intervention | Patients will receive standard postoperative pain control methods as defined by the participating institution |
| Ice | Experimental | Patients will receive ice packs to the abdomen, in addition to standard postoperative pain control methods as defined by the participating institution Receives: Other: Ice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: pain score collected at two weeks post operative.
Secondary outcomes (3)
Narcotic usage
Amount of narcotic pain medicines used as measured in morphine milligram equivalent (MME).
Measured: 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].
Measured: 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.
Measured: day of surgery, up to 1440 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start15 Feb 2019
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Kho, University of Texas Southwestern Medical Center
- Investigators
- Kimberly Kho, MD, Principal investigator, University of Texas as Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145791
- Sponsor's protocol ID
- 072018-055
- Acronym
- Ice-POP
- Status last verified
- Oct 2024
- First submitted
- 1 Mar 2019
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shields JK, Kenyon L, Porter A, Chen J, Chao L, Chang S, Kho KA. Ice-POP: Ice Packs for Postoperative Pain: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2023 Jun;30(6):455-461. doi: 10.1016/j.jmig.2023.01.015. Epub 2023 Feb 4.
PubMed 36740018
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ice Application for Postoperative Pain: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04145791
- Acronym / sponsor ID
- Ice-POP / 072018-055
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Ice | No intervention | –Patients will receive standard postoperative pain control methods as defined by the participating institution |
| Ice | Experimental | Other: IcePatients will receive ice packs to the abdomen, in addition to standard postoperative pain control methods as defined by the participating institution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iceice packs | Other | Ice |
Primary outcome
Pain score of cryotherapy patients as compared to non-cryotherapy patients
Time frame: 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).
Pain score of cryotherapy patients as compared to non-cryotherapy patients
Time frame: pain score collected immediately after 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).
Pain score of cryotherapy patients as compared to non-cryotherapy patients
Time frame: pain score collected post operative day 1
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
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).
3 secondary outcomes
Narcotic usage
Time frame: postoperative day one
Quality of Recovery (QoR)
Time frame: through study completion to take place at preoperative visit, and post operative day #14.
Time to discharge
Time frame: day of surgery, up to 1440 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 36740018Shields JK, Kenyon L, Porter A, Chen J, Chao L, Chang S, Kho KA. Ice-POP: Ice Packs for Postoperative Pain: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2023 Jun;30(6):455-461. doi: 10.1016/j.jmig.2023.01.015. Epub 2023 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Kho, MD principal investigator
University of Texas as Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice in people with Postoperative Pain, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score of cryotherapy patients as compared to non-cryotherapy patients (time frame: pain score collected at admission to the preoperative holding unit prior to surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.