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Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold therapy via reusable cold gel pack
Sponsored by
Cleveland Clinic Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients can understand and voluntarily sign an informed consent form
  2. Female gender ages 18-65
  3. Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy)

Exclusion Criteria:

  1. Conversion to laparotomy
  2. Diagnosis of chronic pelvic pain
  3. No access to freezer at home to keep reusable cold packs cold between uses
  4. Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum)
  5. Medical contraindication to NSAID use

Sites / Locations

  • Cleveland Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cold Therapy

Control

Arm Description

Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.

Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.

Outcomes

Primary Outcome Measures

Post-operative pain score
Post-operative pain score on an 11 point NRS scale

Secondary Outcome Measures

Post-operative pain score
Post-operative pain score on an 11 point NRS scale
Patient reported quantity of narcotics used post-operatively
Patient reported quantity of narcotics used post-operatively
Quality of life score as measured by the validated Abdominal Surgery Impact Scale
Quality of life score as measured by the validated Abdominal Surgery Impact Scale
Surgical recovery score as measured by the validated Surgical Recovery Scale
Surgical recovery score as measured by the validated Surgical Recovery Scale

Full Information

First Posted
April 17, 2017
Last Updated
October 31, 2018
Sponsor
Cleveland Clinic Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03129464
Brief Title
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management
Official Title
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management in Women Undergoing Laparoscopic Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cleveland Clinic Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. After surgery is completed participants will be randomized to either the control group or the study group. The study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. Investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores. This study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. Investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cold Therapy
Arm Type
Experimental
Arm Description
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.
Intervention Type
Device
Intervention Name(s)
Cold therapy via reusable cold gel pack
Intervention Description
Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
Primary Outcome Measure Information:
Title
Post-operative pain score
Description
Post-operative pain score on an 11 point NRS scale
Time Frame
24 hours post-operatively following total laparoscopic hysterectomy
Secondary Outcome Measure Information:
Title
Post-operative pain score
Description
Post-operative pain score on an 11 point NRS scale
Time Frame
72 hours post-operatively following total laparoscopic hysterectomy
Title
Patient reported quantity of narcotics used post-operatively
Description
Patient reported quantity of narcotics used post-operatively
Time Frame
24 and 72 hours post-operatively following total laparoscopic hysterectomy
Title
Quality of life score as measured by the validated Abdominal Surgery Impact Scale
Description
Quality of life score as measured by the validated Abdominal Surgery Impact Scale
Time Frame
72 hours post-operatively following total laparoscopic hysterectomy
Title
Surgical recovery score as measured by the validated Surgical Recovery Scale
Description
Surgical recovery score as measured by the validated Surgical Recovery Scale
Time Frame
10-14 days post-operatively following total laparoscopic hysterectomy
Other Pre-specified Outcome Measures:
Title
Total amount of narcotics used post-operatively
Description
Total amount of narcotics used post-operatively
Time Frame
10-14 days postoperatively following total laparoscopic hysterectomy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients can understand and voluntarily sign an informed consent form Female gender ages 18-65 Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy) Exclusion Criteria: Conversion to laparotomy Diagnosis of chronic pelvic pain No access to freezer at home to keep reusable cold packs cold between uses Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum) Medical contraindication to NSAID use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Sprague, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management

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