Cold Therapy for Pain Control Following Caesarean Section

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

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.

Study Overview

• Status: Terminated
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: Alkantis

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Repeat C/S Control; Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings.
Active Comparator: Repeat C/S Treatment; Repeat C/S done with spinal with Alkantis ice pack.	Other: Alkantis; cold therapy pack placed on the wound post operatively
No Intervention: Primary C/S - Control; Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings.
Active Comparator: Primary C/S Treatment; Primary C/S done with Epidural with Alkantis ice pack.	Other: Alkantis; cold therapy pack placed on the wound post operatively

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic Utilization	Evaluate total narcotics used during time frame	48 hours after surgrey

Collaborators and Investigators

• Sponsor: University of Tennessee
• Investigators: Principal Investigator: William E Gist, M.D., University of Tennessee College of Medicine- Chattanooga; Study Director: Kreg Jonson, M.D., University of Tennessee College of Medicine- Chattanooga; Study Director: Mandi Raper, University of Tennessee College of Medicine- Chattanooga; Study Director: Erin Tannous, MD, University of Tennessee College of Medicine- Chattanooga; Study Chair: Olkayoude Akinlaja, MD, University of Tennessee College of Medicine- Chattanooga

Publications and helpful links

General Publications

• Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
• Kullenberg B, Ylipaa S, Soderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9. doi: 10.1016/j.arth.2006.02.159.
• Placek PJ, Taffel SM. Trends in cesarean section rates for the United States, 1970--78. Public Health Rep. 1980 Nov-Dec;95(6):540-8.
• Placek PJ, Taffel S, Moien M. Cesarean section delivery rates: United States, 1981. Am J Public Health. 1983 Aug;73(8):861-2. doi: 10.2105/ajph.73.8.861.
• Stafford RS. Alternative strategies for controlling rising cesarean section rates. JAMA. 1990 Feb 2;263(5):683-7.
• Amin-Hanjani S, Corcoran J, Chatwani A. Cold therapy in the management of postoperative cesarean section pain. Am J Obstet Gynecol. 1992 Jul;167(1):108-9. doi: 10.1016/s0002-9378(11)91638-x.
• Koc M, Tez M, Yoldas O, Dizen H, Gocmen E. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia. 2006 Apr;10(2):184-6. doi: 10.1007/s10029-005-0062-2. Epub 2006 Jan 24.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 14-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO