Cold Therapy for Pain Control Following Caesarean Section

Not Applicable

Terminated

• Conditions: Post Operative Pain
• Interventions: Other: Alkantis

• Registration Number: NCT03711994
• Lead Sponsor: University of Tennessee

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).

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-25
• Status Verified: 2018-04
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-19
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Repeat C/S Treatment	Alkantis	Repeat C/S done with spinal with Alkantis ice pack.
Primary C/S Treatment	Alkantis	Primary C/S done with Epidural with Alkantis ice pack.

Primary Outcome Measures

Name	Time	Method
Post Operative Pain	48 hours after surgery	Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.

Secondary Outcome Measures

Name	Time	Method
Narcotic Utilization	48 hours after surgrey	Evaluate total narcotics used during time frame

Trial Locations

Locations (1)

Erlanger Hospital; 🇺🇸 Chattanooga, Tennessee, United States