Cold Therapy for Pain Control Following Caesarean Section

Study Overview
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Brief Summary
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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
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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).

Official Title
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Cold Therapy for Pain Control Following Caesarean Section at Erlanger Baroness Hospital

Conditions
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Post Operative Pain

Intervention / Treatment
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* Other: Alkantis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Repeat C/S Control<br>Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings. | |
| Active Comparator: Repeat C/S Treatment<br>Repeat C/S done with spinal with Alkantis ice pack. | Other: Alkantis<br>* cold therapy pack placed on the wound post operatively<br>|
| No Intervention: Primary C/S - Control<br>Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings. | |
| Active Comparator: Primary C/S Treatment<br>Primary C/S done with Epidural with Alkantis ice pack. | Other: Alkantis<br>* cold therapy pack placed on the wound post operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain | Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period. | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Utilization | Evaluate total narcotics used during time frame | 48 hours after surgrey |