Cold Therapy for Pain Control Following Caesarean Section

University of Tennessee

Status: Terminated

Conditions: Post Operative Pain

Treatments: Other: Alkantis

Study type: Interventional

Funder types: Other

Identifiers

NCT03711994

14-133

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2 patients

Sex: Female

Ages: 16 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 4 patient groups

Repeat C/S Control

No Intervention group

Description:

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

Repeat C/S Treatment

Active Comparator group

Description:

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

Treatment:

Other: Alkantis

Primary C/S - Control

No Intervention group

Description:

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

Primary C/S Treatment

Active Comparator group

Description:

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

Treatment:

Other: Alkantis