Skip to content

Cold Therapy for Pain Control Following Caesarean Section

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03711994
Enrollment
2
Registered
2018-10-19
Start date
2015-12-31
Completion date
2019-12-31
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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).

Interventions

OTHERAlkantis

cold therapy pack placed on the wound post operatively

Sponsors

University of Tennessee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 43 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Pain48 hours after surgeryWill Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.

Secondary

MeasureTime frameDescription
Narcotic Utilization48 hours after surgreyEvaluate total narcotics used during time frame

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026