Abdominal Ice Application After Cesarean Section (ICE-CS)
29 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Niğde, Turkiet (Türkiye), 51200
- Nigde Omer Halisdemir University Training and Research Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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Intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours.
Andra namn:
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Aktiv komparator: Control Group
Participants received standard postoperative multimodal analgesia without abdominal ice application.
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Standard postoperative multimodal analgesia without abdominal ice application.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Tidsram: During the first 24 postoperative hours
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Postoperative pain intensity was evaluated using the Numeric Rating Scale (NRS; 0-10) at predefined postoperative time points during the first 24 postoperative hours.
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During the first 24 postoperative hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Tramadol Consumption
Tidsram: 24 postoperative hours
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Total postoperative tramadol consumption during the first 24 postoperative hours.
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24 postoperative hours
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Postoperative Morphine Consumption
Tidsram: 24 postoperative hours
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Total postoperative morphine consumption during the first 24 postoperative hours.
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24 postoperative hours
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Patient Satisfaction Scores
Tidsram: 24 postoperative hours
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Patient satisfaction with postoperative pain management assessed during the postoperative period.
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24 postoperative hours
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2022
Primärt slutförande (Faktisk)
1 oktober 2022
Avslutad studie (Faktisk)
1 oktober 2022
Studieregistreringsdatum
Först inskickad
29 maj 2026
Först inskickad som uppfyllde QC-kriterierna
29 maj 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NOHU-CS-ICE-2022
- 2022/33 (Registeridentifierare: Niğde Ömer Halisdemir University Non-Interventional Clinical Research Ethics Committee)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified individual participant data underlying the results reported in this study will be available from the corresponding author upon reasonable request following publication.
Tidsram för IPD-delning
Upon publication of the study
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
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Nej
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