NCT03711994

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 2, 2022

Status Verified

April 1, 2018

Enrollment Period

4 years

First QC Date

January 25, 2016

Last Update Submit

June 1, 2022

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Post Operative Pain

    Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.

    48 hours after surgery

Secondary Outcomes (1)

  • Narcotic Utilization

    48 hours after surgrey

Study Arms (4)

Repeat C/S Control

NO INTERVENTION

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

Repeat C/S Treatment

ACTIVE COMPARATOR

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

Other: Alkantis

Primary C/S - Control

NO INTERVENTION

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

Primary C/S Treatment

ACTIVE COMPARATOR

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

Other: Alkantis

Interventions

AlkantisOTHER

cold therapy pack placed on the wound post operatively

Primary C/S TreatmentRepeat C/S Treatment

Eligibility Criteria

Age16 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • greater than 36 weeks gestation
  • primary C/S with Epidural for labor problems or breech presentation
  • Repeat C/S with spinal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erlanger Hospital

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (7)

  • 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.

    PMID: 7433601BACKGROUND

  • 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.

    PMID: 6869638BACKGROUND

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

    PMID: 2296123BACKGROUND

  • 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.

    PMID: 1442907BACKGROUND

  • 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.

    PMID: 16432641BACKGROUND

  • 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.

    PMID: 17162178BACKGROUND

  • 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.

    PMID: 32871021DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • William E Gist, M.D.

    University of Tennessee College of Medicine- Chattanooga

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

  • Olkayoude Akinlaja, MD

    University of Tennessee College of Medicine- Chattanooga

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

October 19, 2018

Study Start

December 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 2, 2022

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)