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| ID | Type | Description | Link |
|---|---|---|---|
| 2022/33 | Registry Identifier | Niğde Ömer Halisdemir University Non-Interventional Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice Group | Experimental | 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. |
|
| Control Group | Active Comparator | Participants received standard postoperative multimodal analgesia without abdominal ice application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal Ice Application | Procedure | Intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (NRS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Tramadol Consumption | Total postoperative tramadol consumption during the first 24 postoperative hours. | 24 postoperative hours |
| Postoperative Morphine Consumption | Total postoperative morphine consumption during the first 24 postoperative hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niğde Ömer Halisdemir University Training and Research Hospital | Niğde | 51200 | Turkey (Türkiye) |
De-identified individual participant data underlying the results reported in this study will be available from the corresponding author upon reasonable request following publication.
Upon publication of the study
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.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Participants were randomly assigned in a 1:1 ratio to either the ice application group or the control group.
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Postoperative pain assessments were performed by an investigator blinded to group allocation. Participants and care providers were not blinded because of the nature of
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| Standard Postoperative Care | Other | Standard postoperative multimodal analgesia without abdominal ice application. |
|
| 24 postoperative hours |
| Patient Satisfaction Scores | Patient satisfaction with postoperative pain management assessed during the postoperative period. | 24 postoperative hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |