NCT04145791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2021

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

March 1, 2019

Last Update Submit

October 25, 2024

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Narcotic usage

    postoperative day one

  • Quality of Recovery (QoR)

    through study completion to take place at preoperative visit, and post operative day #14.

  • Time to discharge

    day of surgery, up to 1440 minutes

Study Arms (2)

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

Other: Ice

Interventions

IceOTHER

ice packs

Ice

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

Clements University Hospital

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • 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.

    PMID: 36740018DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ice

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEnvironmentEcological and Environmental PhenomenaBiological PhenomenaWeatherMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Kimberly Kho, MD

    University of Texas as Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 1, 2019

First Posted

October 31, 2019

Study Start

February 15, 2019

Primary Completion

February 3, 2021

Study Completion

February 3, 2021

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)