Abdominal Ice Application After Cesarean Section

NCT07626138 | Completed

• 2 other identifiers: NOHU-CS-ICE-20222022/33
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Cesarean Section; Postoperative Pain After Cesarean Section

Keywords

Cesarean Section; Postoperative Pain; Cryotherapy; Abdominal Ice Application; Multimodal Analgesia; Opioid-Sparing Analgesia; Spinal Anesthesia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Postoperative Tramadol Consumption

  24 postoperative hours

• Postoperative Morphine Consumption

  24 postoperative hours

• Patient Satisfaction Scores

  24 postoperative hours

Study Arms (2)

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.

Procedure: Abdominal Ice Application

Control Group

ACTIVE COMPARATOR

Participants received standard postoperative multimodal analgesia without abdominal ice application.

Other: Standard Postoperative Care

Interventions

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.

Also known as: Cryotherapy, Cold Gel Pack Application

Ice Group

Standard Postoperative Care OTHER

Standard postoperative multimodal analgesia without abdominal ice application.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Training and Research Hospital

Niğde, 51200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative pain assessments were performed by an investigator blinded to group allocation. Participants and care providers were not blinded because of the nature of
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned in a 1:1 ratio to either the ice application group or the control group.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: May 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication of the study
• Access Criteria: 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.

Locations

TU (1)