search
Back to results

Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy (Ice)

Primary Purpose

Urologic Surgical Procedure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ice pack
Sponsored by
Viraj Master
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urologic Surgical Procedure focused on measuring abdominal surgery, cryotherapy, pain score, narcotic utilization

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any open transperitoneal abdominal surgery with a midline incision

Exclusion Criteria:

  • Additional surgeries required

Sites / Locations

  • Grady Hospital
  • Emory University, Urology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cryotherapy

Control

Arm Description

Patients in the cryotherapy study group will have ice packs placed on their abdominal wound for the first hour following surgery.

No adjunctive therapy following abdominal surgery.

Outcomes

Primary Outcome Measures

Change in postoperative pain score
Throughout the hospital stay nurses will assess patients pain levels. Patients will complete a visual analog score one hour postoperatively and then at 8am and 4 pm each day.

Secondary Outcome Measures

Narcotic use
Throughout the hospital stay nurses will check the amount of narcotics patients require for pain control. All narcotic use will be documented and converted to morphine equivalents using an equianalgesic table provided by the Emory University Department of Palliative Care.

Full Information

First Posted
October 18, 2013
Last Updated
October 28, 2013
Sponsor
Viraj Master
search

1. Study Identification

Unique Protocol Identification Number
NCT01974882
Brief Title
Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy
Acronym
Ice
Official Title
Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Viraj Master

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Postoperative pain is an unavoidable consequence of open abdominal surgery. Although cryotherapy, the application of ice to a surgical wound site, has been shown to be effective in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not been assessed in patients who undergo major open abdominal operations. We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcome measure. This would result in less narcotic analgesia usage, and shorter hospital stays as secondary outcome measures.
Detailed Description
Objectives: This study will attempt to assess the impact of cryotherapy on post-surgical inflammation and narcotic use. End-points for the study will be patient use of narcotics and pain level, regularly measured by nursing staff. Patient Selection: This study will accept all consecutive consenting patients who visit the Grady Hospital and Emory University urology clinics who require abdominal surgery.The study will require 55 patients, based on prior power calculations. Registration/Randomization: Because this study will enroll all consenting patients, no registration is required. Patients will be enrolled by their urologist during a standard visit. With consent, the urologist will direct the patient to the researcher. Patients will be randomized to either cryotherapy or no adjunctive therapy following abdominal surgery. Therapy: Patients in the cryotherapy study group will have ice packs placed on their abdominal wound for 24 hours following surgery.After 24 hours, patients had the option of using ice packs for as long as they wished. Patient Assessment: Patients will be assessed by the nursing staff as they would otherwise be assessed postsurgically. Data Collection: During recovery time in the hospital, nurses will monitor both groups of patients as they do all patients. As with all patients, nurses will ask about pain levels and check the amount of narcotics you require for pain control. This study will not require any additional effort on patients' part. Once they are discharged, patient participation in the study will be complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Surgical Procedure
Keywords
abdominal surgery, cryotherapy, pain score, narcotic utilization

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
Patients in the cryotherapy study group will have ice packs placed on their abdominal wound for the first hour following surgery.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No adjunctive therapy following abdominal surgery.
Intervention Type
Other
Intervention Name(s)
Ice pack
Intervention Description
Cryotherapy was applied via reusable ice bags filled with ice. Ice packs were immediately applied after the dressing was placed on the wound. The ice pack maintained in place for a continuous 24 hours adn was refilled as needed. After twenty-four hours, patients had the option of using ice packs for as long as they wished. The duration of ice pack usage was noted.
Primary Outcome Measure Information:
Title
Change in postoperative pain score
Description
Throughout the hospital stay nurses will assess patients pain levels. Patients will complete a visual analog score one hour postoperatively and then at 8am and 4 pm each day.
Time Frame
Participants will be followed for the duration of hospital stay, an average of 7 days
Secondary Outcome Measure Information:
Title
Narcotic use
Description
Throughout the hospital stay nurses will check the amount of narcotics patients require for pain control. All narcotic use will be documented and converted to morphine equivalents using an equianalgesic table provided by the Emory University Department of Palliative Care.
Time Frame
Participants will be followed for the duration of hospital stay, an average of 7 days
Other Pre-specified Outcome Measures:
Title
Length of hospital stay
Description
Length of hospital stay will be recorded in patient records.
Time Frame
Participants will be followed for the duration of hospital stay, an average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any open transperitoneal abdominal surgery with a midline incision Exclusion Criteria: Additional surgeries required
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viraj Master, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University, Urology Department
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy

We'll reach out to this number within 24 hrs