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Abdominal Ice Application After Cesarean Section (ICE-CS)

29. maj 2026 opdateret af: Seval KILBASANLI, Nigde Omer Halisdemir University

Effect of Intermittent Abdominal Ice Application on Postoperative Pain and Opioid Consumption After Elective Cesarean Section: A Randomized Controlled Study

Cesarean section is one of the most commonly performed surgical procedures worldwide, and effective postoperative pain control is important for maternal recovery and patient comfort. This randomized controlled study evaluated whether intermittent abdominal ice application after elective cesarean section could reduce postoperative pain and opioid consumption. Eighty patients undergoing cesarean delivery under spinal anesthesia were randomly assigned to receive either intermittent abdominal ice application in addition to standard multimodal analgesia or standard postoperative care alone. Postoperative pain scores, opioid consumption, patient satisfaction, and postoperative recovery outcomes were evaluated during the first 24 postoperative hours.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This prospective randomized controlled study was conducted to evaluate the effects of intermittent abdominal ice application on postoperative pain and opioid consumption after elective cesarean section. Eighty patients undergoing elective cesarean delivery under spinal anesthesia were randomly assigned in a 1:1 ratio to either an ice application group or a control group. Patients in the intervention group received intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours in addition to standard multimodal analgesia. The control group received standard postoperative multimodal analgesia alone.

Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS) at predefined postoperative time points during the first 24 hours. Secondary outcomes included tramadol consumption, morphine consumption, patient satisfaction, first analgesic request time, total postoperative pain burden assessed using area under the curve (AUC) analysis, and responder analysis. The study was approved by the local ethics committee, and written informed consent was obtained from all participants before enrollment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Niğde, Tyrkiet (Türkiye), 51200
        • Niğde Ömer Halisdemir University Training and Research Hospital

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

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Women aged 18-45 years American Society of Anesthesiologists (ASA) physical status I-II Singleton term pregnancy Elective cesarean section performed under spinal anesthesia Ability to understand and use the Numeric Rating Scale (NRS) Written informed consent obtained before participation

Exclusion Criteria:

  • Emergency cesarean section Chronic pain disorders or chronic opioid use Allergy or contraindication to study medications Infection or skin lesion at the ice application site Psychiatric or neurological disorders affecting pain assessment Conversion to general anesthesia Refusal to participate in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ice Group
Participants received intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours in addition to standard postoperative multimodal analgesia.
Procedure: Abdominal Ice Application
Intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours.
Andre navne:
  • Kryoterapi
  • Cold Gel Pack Application
Aktiv komparator: Control Group
Participants received standard postoperative multimodal analgesia without abdominal ice application.
Andet: Standard Postoperative Care
Standard postoperative multimodal analgesia without abdominal ice application.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Tidsramme: During the first 24 postoperative hours
Postoperative pain intensity was evaluated using the Numeric Rating Scale (NRS; 0-10) at predefined postoperative time points during the first 24 postoperative hours.
During the first 24 postoperative hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Tramadol Consumption
Tidsramme: 24 postoperative hours
Total postoperative tramadol consumption during the first 24 postoperative hours.
24 postoperative hours
Postoperative Morphine Consumption
Tidsramme: 24 postoperative hours
Total postoperative morphine consumption during the first 24 postoperative hours.
24 postoperative hours
Patient Satisfaction Scores
Tidsramme: 24 postoperative hours
Patient satisfaction with postoperative pain management assessed during the postoperative period.
24 postoperative hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nigde Omer Halisdemir University

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 (Faktiske)

1. maj 2022

Primær færdiggørelse (Faktiske)

1. oktober 2022

Studieafslutning (Faktiske)

1. oktober 2022

Datoer for studieregistrering

Først indsendt

29. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NOHU-CS-ICE-2022
  • 2022/33 (Registry Identifier: Niğde Ömer Halisdemir University Non-Interventional Clinical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in this study will be available from the corresponding author upon reasonable request following publication.

IPD-delingstidsramme

Upon publication of the study

IPD-delingsadgangskriterier

De-identified individual participant data (IPD) and study protocol-related documents will be available to researchers who provide a methodologically sound proposal. Access will be granted for academic research purposes only after publication of the study. Requests should be directed to the corresponding author. Data will be shared in a secure electronic format after approval of the proposal and signing of a data-sharing agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Abdominal Ice Application

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