Cold Therapy for Pain Control Following Caesarean Section

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03711994
• Other study ID #: 14-133
• Status: Terminated
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Alkantis
cold therapy pack placed on the wound post operatively

Locations

Country	Name	City	State
United States	Erlanger Hospital	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Koç M, Tez M, Yoldas O, Dizen H, Göçmen E. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia. 2006 Apr;10(2):184-6. Epub 2006 Jan 24. — View Citation

Kullenberg B, Ylipää S, Söderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9. — View Citation

Placek PJ, Taffel S, Moien M. Cesarean section delivery rates: United States, 1981. Am J Public Health. 1983 Aug;73(8):861-2. — View Citation

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. — View Citation

Stafford RS. Alternative strategies for controlling rising cesarean section rates. JAMA. 1990 Feb 2;263(5):683-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Pain	Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.	48 hours after surgery
Secondary	Narcotic Utilization	Evaluate total narcotics used during time frame	48 hours after surgrey