- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03711994
Cold Therapy for Pain Control Following Caesarean Section
1. juni 2022 opdateret af: University of Tennessee
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.
Studieoversigt
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37403
- Erlanger Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 43 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Repeat C/S Control
Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings.
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Aktiv komparator: Repeat C/S Treatment
Repeat C/S done with spinal with Alkantis ice pack.
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cold therapy pack placed on the wound post operatively
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Ingen indgriben: Primary C/S - Control
Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings.
|
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Aktiv komparator: Primary C/S Treatment
Primary C/S done with Epidural with Alkantis ice pack.
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cold therapy pack placed on the wound post operatively
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Post Operative Pain
Tidsramme: 48 hours after surgery
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Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.
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48 hours after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Narcotic Utilization
Tidsramme: 48 hours after surgrey
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Evaluate total narcotics used during time frame
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48 hours after surgrey
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: William E Gist, M.D., University of Tennessee College of Medicine- Chattanooga
- Studieleder: Kreg Jonson, M.D., University of Tennessee College of Medicine- Chattanooga
- Studieleder: Mandi Raper, University of Tennessee College of Medicine- Chattanooga
- Studieleder: Erin Tannous, MD, University of Tennessee College of Medicine- Chattanooga
- Studiestol: Olkayoude Akinlaja, MD, University of Tennessee College of Medicine- Chattanooga
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2015
Primær færdiggørelse (Faktiske)
1. december 2019
Studieafslutning (Faktiske)
1. december 2019
Datoer for studieregistrering
Først indsendt
25. januar 2016
Først indsendt, der opfyldte QC-kriterier
16. oktober 2018
Først opslået (Faktiske)
19. oktober 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2022
Sidst verificeret
1. april 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14-133
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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