- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07626138
Abdominal Ice Application After Cesarean Section (ICE-CS)
Effect of Intermittent Abdominal Ice Application on Postoperative Pain and Opioid Consumption After Elective Cesarean Section: A Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Niğde, Turkey (Türkiye), 51200
- Niğde Ömer Halisdemir University Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours.
Other Names:
|
|
Active Comparator: Control Group
Participants received standard postoperative multimodal analgesia without abdominal ice application.
|
Standard postoperative multimodal analgesia without abdominal ice application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Tramadol Consumption
Time Frame: 24 postoperative hours
|
Total postoperative tramadol consumption during the first 24 postoperative hours.
|
24 postoperative hours
|
|
Postoperative Morphine Consumption
Time Frame: 24 postoperative hours
|
Total postoperative morphine consumption during the first 24 postoperative hours.
|
24 postoperative hours
|
|
Patient Satisfaction Scores
Time Frame: 24 postoperative hours
|
Patient satisfaction with postoperative pain management assessed during the postoperative period.
|
24 postoperative hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOHU-CS-ICE-2022
- 2022/33 (Registry Identifier: Niğde Ömer Halisdemir University Non-Interventional Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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