Trials / Terminated
TerminatedNCT03711994
Cold Therapy for Pain Control Following Caesarean Section
Cold Therapy for Pain Control Following Caesarean Section at Erlanger Baroness Hospital
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- University of Tennessee · Academic / Other
- Sex
- Female
- Age
- 16 Years – 43 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Alkantis | cold therapy pack placed on the wound post operatively |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2018-10-19
- Last updated
- 2022-06-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03711994. Inclusion in this directory is not an endorsement.