NCT03341533

Brief Summary

The purpose of this study is to evaluate the effect of using ice packs on the abdomen immediately after laparoscopic hysterectomy surgery on pain control and narcotic pain medication use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 12, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
28 days until next milestone

Results Posted

Study results publicly available

May 14, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

November 8, 2017

Results QC Date

April 21, 2020

Last Update Submit

May 3, 2020

Conditions

Pain, PostoperativeHysterectomyNarcotic UseCryotherapy Effect

Keywords

AnalgesiaLaparoscopyPain

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Intensity Scale

    Self-reported pain intensity scores (Numerical Pain Intensity Scale, 0-10 visual analog scale with 0 representing no pain and 10 representing the worst pain imaginable) assessed and documented a minimum every four hours post-operatively. Mean differences of pain intensity assessed between ice group and usual care group.

    12 hours post-operatively

  • Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor

    Calculation of average patient MME from the time enter hospital floor to hospital discharge. Administered narcotics will be abstracted from the medical record and converted to total MME for analysis.

    an average of one day from entering hospital floor to discharge

Secondary Outcomes (2)

  • Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient

    2 weeks

  • Brief Pain Inventory Short Form - Postoperative Pain Severity

    one day after surgery

Study Arms (2)

Ice packs plus usual post-op analgesia

EXPERIMENTAL

Ice pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice.

Procedure: Ice packs plus usual post-op analgesiaOther: Usual post-op analgesia

Usual post-op analgesia

ACTIVE COMPARATOR

Standard post-operative analgesia only, no ice use.

Other: Usual post-op analgesia

Interventions

Ice packs plus usual post-op analgesiaPROCEDURE

A 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines.

Ice packs plus usual post-op analgesia
Usual post-op analgesiaOTHER

Standard post-operative analgesia orders will be followed.

Ice packs plus usual post-op analgesiaUsual post-op analgesia

Eligibility Criteria

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

You may qualify if:

  • Women undergoing robotic or conventional laparoscopic hysterectomy

You may not qualify if:

  • Any opioid use within 2 weeks of surgery date
  • Planned post-operative ICU admission
  • Conversion of laparoscopic approach to laparotomy or any incision ≥4 cm
  • Regional anesthesia/analgesia, including tap block use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Cope AG, Wetzstein MM, Mara KC, Laughlin-Tommaso SK, Warner NS, Burnett TL. Abdominal Ice after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):342-350.e2. doi: 10.1016/j.jmig.2020.06.027. Epub 2020 Jul 3.

    PMID: 32622918DERIVED

Related Links

MeSH Terms

Conditions

Pain, PostoperativeAgnosiaPain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Results Point of Contact

Title
Dr. Tatnai Burnett
Organization
Mayo Clinic
burnett.tatnai@mayo.edu
507-538-5783

Study Officials

  • Tatnai L. Burnett, M.D.

    Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Consultant

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 14, 2017

Study Start

January 12, 2018

Primary Completion

April 5, 2019

Study Completion

April 16, 2020

Last Updated

May 14, 2020

Results First Posted

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)