Clinical trial NCT03711994: 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
Overall status: TERMINATED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 2
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 43
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Post Operative Pain
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Narcotic Utilization
timeFrame: 48 hours after surgrey
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Hospital
state: Tennessee
Study officials:
affiliation: University of Tennessee College of Medicine- Chattanooga
name: William E Gist, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee College of Medicine- Chattanooga
name: Kreg Jonson, M.D.
role: STUDY_DIRECTOR
affiliation: University of Tennessee College of Medicine- Chattanooga
name: Mandi Raper
role: STUDY_DIRECTOR
affiliation: University of Tennessee College of Medicine- Chattanooga
name: Erin Tannous, MD
role: STUDY_DIRECTOR
affiliation: University of Tennessee College of Medicine- Chattanooga
name: Olkayoude Akinlaja, MD
role: STUDY_CHAIR
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