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Cold Therapy for Pain Control Following Caesarean Section

Primary Purpose

Post Operative Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alkantis
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

16 Years - 43 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • greater than 36 weeks gestation
  • primary C/S with Epidural for labor problems or breech presentation
  • Repeat C/S with spinal

Exclusion Criteria:

  • less than 36.0 week gestations
  • vertical skin incisions
  • classical or vertical hysterotomy incisions
  • failed vaginal births after C/S (VBAC)
  • past history of drug or alcohol abuse
  • positive drug screens unless medical prescribed drugs
  • general anesthesia
  • Caesarean Hysterectomy
  • primary C/S with spinal anesthesia

Sites / Locations

  • Erlanger Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

No Intervention

Active Comparator

Arm Label

Repeat C/S Control

Repeat C/S Treatment

Primary C/S - Control

Primary C/S Treatment

Arm Description

Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings.

Repeat C/S done with spinal with Alkantis ice pack.

Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings.

Primary C/S done with Epidural with Alkantis ice pack.

Outcomes

Primary Outcome Measures

Post Operative Pain
Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.

Secondary Outcome Measures

Narcotic Utilization
Evaluate total narcotics used during time frame

Full Information

First Posted
January 25, 2016
Last Updated
June 1, 2022
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT03711994
Brief Title
Cold Therapy for Pain Control Following Caesarean Section
Official Title
Cold Therapy for Pain Control Following Caesarean Section at Erlanger Baroness Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to get product at this time
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cold Therapy has been used for a variety of procedures and has been studied in several but not recently studied for reducing postop pain following Caesarean Sections. The hypothesis is that Cold Therapy will reduce postop pain and increase patients mobility and improve care of her newborn.
Detailed Description
Cesarean Section (C/S) is one of the most commonly performed surgeries in many parts of the world. In the United States the C/S rate in 1965 was 4.5% and increased to 30.5% in 2010. While the number of C/S has increased, pain management has primarily been via epidural, spinal, local and general anesthesia and narcotic medication for the immediate postpartum period (pp). This has lead to an increase in associated cost and problems with pain management. Limited studies have been performed to evaluate cold compresses on pain relief in the immediate pp and there potential to reduce cost. Cold Therapy (CT) is most often utilized in orthopedics, sports medicine, and in general surgery. CT has been used to improve range of motion (rom) and reduce pain medication utilization. We surmise CT may be useful in decreasing narcotic utilization after C/S, as well as improve mobility and allow for improved care of the newborn. This is significant as Erlanger Baroness Hospital (EBH) is becoming Baby Friendly (BF). This is a National Initiative for Children's Healthcare Quality (NICHQ) which desires having babies rooming in with their mothers and increasing breastfeeding rates. The goal of this study is to evaluate a newer sterile delivery system for decreasing pp pain via CT. This will be done as a Randomized Controlled Trial (RCT).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repeat C/S Control
Arm Type
No Intervention
Arm Description
Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings.
Arm Title
Repeat C/S Treatment
Arm Type
Active Comparator
Arm Description
Repeat C/S done with spinal with Alkantis ice pack.
Arm Title
Primary C/S - Control
Arm Type
No Intervention
Arm Description
Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings.
Arm Title
Primary C/S Treatment
Arm Type
Active Comparator
Arm Description
Primary C/S done with Epidural with Alkantis ice pack.
Intervention Type
Other
Intervention Name(s)
Alkantis
Intervention Description
cold therapy pack placed on the wound post operatively
Primary Outcome Measure Information:
Title
Post Operative Pain
Description
Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
Narcotic Utilization
Description
Evaluate total narcotics used during time frame
Time Frame
48 hours after surgrey

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: greater than 36 weeks gestation primary C/S with Epidural for labor problems or breech presentation Repeat C/S with spinal Exclusion Criteria: less than 36.0 week gestations vertical skin incisions classical or vertical hysterotomy incisions failed vaginal births after C/S (VBAC) past history of drug or alcohol abuse positive drug screens unless medical prescribed drugs general anesthesia Caesarean Hysterectomy primary C/S with spinal anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Gist, M.D.
Organizational Affiliation
University of Tennessee College of Medicine- Chattanooga
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kreg Jonson, M.D.
Organizational Affiliation
University of Tennessee College of Medicine- Chattanooga
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mandi Raper
Organizational Affiliation
University of Tennessee College of Medicine- Chattanooga
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erin Tannous, MD
Organizational Affiliation
University of Tennessee College of Medicine- Chattanooga
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Olkayoude Akinlaja, MD
Organizational Affiliation
University of Tennessee College of Medicine- Chattanooga
Official's Role
Study Chair
Facility Information:
Facility Name
Erlanger Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7433601
Citation
Placek PJ, Taffel SM. Trends in cesarean section rates for the United States, 1970--78. Public Health Rep. 1980 Nov-Dec;95(6):540-8.
Results Reference
background
PubMed Identifier
6869638
Citation
Placek PJ, Taffel S, Moien M. Cesarean section delivery rates: United States, 1981. Am J Public Health. 1983 Aug;73(8):861-2. doi: 10.2105/ajph.73.8.861.
Results Reference
background
PubMed Identifier
2296123
Citation
Stafford RS. Alternative strategies for controlling rising cesarean section rates. JAMA. 1990 Feb 2;263(5):683-7.
Results Reference
background
PubMed Identifier
1442907
Citation
Amin-Hanjani S, Corcoran J, Chatwani A. Cold therapy in the management of postoperative cesarean section pain. Am J Obstet Gynecol. 1992 Jul;167(1):108-9. doi: 10.1016/s0002-9378(11)91638-x.
Results Reference
background
PubMed Identifier
16432641
Citation
Koc M, Tez M, Yoldas O, Dizen H, Gocmen E. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia. 2006 Apr;10(2):184-6. doi: 10.1007/s10029-005-0062-2. Epub 2006 Jan 24.
Results Reference
background
PubMed Identifier
17162178
Citation
Kullenberg B, Ylipaa S, Soderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9. doi: 10.1016/j.arth.2006.02.159.
Results Reference
background
PubMed Identifier
32871021
Citation
Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
Results Reference
derived

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Cold Therapy for Pain Control Following Caesarean Section

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