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Completed

NCT Number: NCT07626138

Abdominal Ice Application After Cesarean Section

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Niğde Ömer Halisdemir University Training and Research Hospital

Niğde, 51200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cryotherapy, Cold Gel Pack Application

Standard Postoperative Care

Other

Standard postoperative multimodal analgesia without abdominal ice application.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Tramadol Consumption

    Time frame: 24 postoperative hours

    Total postoperative tramadol consumption during the first 24 postoperative hours.

  2. Postoperative Morphine Consumption

    Time frame: 24 postoperative hours

    Total postoperative morphine consumption during the first 24 postoperative hours.

  3. Patient Satisfaction Scores

    Time frame: 24 postoperative hours

    Patient satisfaction with postoperative pain management assessed during the postoperative period.

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

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

Acronym: ICE-CS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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