Cold Therapy for Pain Control Following Caesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-12-31

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.

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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).

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Repeat C/S Control

Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings.

Group Type NO_INTERVENTION

No interventions assigned to this group

Repeat C/S Treatment

Repeat C/S done with spinal with Alkantis ice pack.

Group Type ACTIVE_COMPARATOR

Alkantis

Intervention Type OTHER

cold therapy pack placed on the wound post operatively

Primary C/S - Control

Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings.

Group Type NO_INTERVENTION

No interventions assigned to this group

Primary C/S Treatment

Primary C/S done with Epidural with Alkantis ice pack.

Group Type ACTIVE_COMPARATOR

Alkantis

Intervention Type OTHER

cold therapy pack placed on the wound post operatively

Interventions

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Alkantis

cold therapy pack placed on the wound post operatively

Intervention Type OTHER

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR