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NCT Number: NCT07789301

Predictors of Severe Postoperative Pain Within 24 Hours After Elective Cesarean Delivery Under Spinal Anesthesia

This prospective observational study aims to identify predictors of severe postoperative pain during the first 24 hours after elective cesarean delivery under spinal anesthesia. Preoperative, intraoperative, and postoperative factors will be evaluated to determine their association with severe postoperative pain.

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Key information

Conditions

Cesarean Section Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain After Cesarean Section Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

Location status: Recruiting

Location contact

emre ulusoy

CONTACT

[email protected]

05379492799

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women aged 18-45 years.
  • Elective cesarean delivery under spinal anesthesia.
  • Ability to understand Turkish.
  • Written informed consent.

Exclusion criteria

  • Emergency cesarean delivery.
  • Conversion to general anesthesia.
  • Major obstetric hemorrhage.
  • Intensive care requirement.
  • Chronic opioid use.
  • Severe psychiatric or neurological disease.
  • Inability to communicate.

Treatment and study plan

Observational Assessment of Postoperative Pain

Other

Participants will receive routine spinal anesthesia and standard perioperative care for elective cesarean delivery. Preoperative, intraoperative, and postoperative variables will be recorded without any study-specific intervention.

Primary outcomes

  1. Incidence of Severe Postoperative Pain

    Time frame: Within 24 hours after surgery

    Severe postoperative pain will be defined as a Numerical Rating Scale score of 6 or higher. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity.

Secondary outcomes

  1. Preoperative Anxiety Score

    Time frame: Before surgery

    Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale anxiety subscale. Scores range from 4 to 20, with higher scores indicating greater anxiety.

  2. Preoperative Information Requirement Score

    Time frame: Before surgery

    Information requirements will be assessed using the Amsterdam Preoperative Anxiety and Information Scale information subscale. Scores range from 2 to 10, with higher scores indicating greater information needs.

  3. Expected Postoperative Pain

    Time frame: Before surgery

    Expected postoperative pain will be assessed using a Numerical Rating Scale ranging from 0 to 10, with higher scores indicating greater expected pain.

  4. Intraoperative Visceral Pain

    Time frame: During surgery

    The proportion of patients who experience visceral pain during cesarean delivery under spinal anesthesia will be recorded as a binary outcome (Yes/No).

  5. Incidence of Intraoperative Shoulder Pain

    Time frame: During surgery

    The proportion of patients who experience shoulder pain during cesarean delivery under spinal anesthesia will be recorded as a binary outcome (Yes/No).

  6. Incidence of Intraoperative Hypotension

    Time frame: During surgery

    The occurrence of hypotension during cesarean delivery under spinal anesthesia will be recorded.

  7. Intraoperative Vasopressor Requirement

    Time frame: During surgery

    The requirement for vasopressor administration during cesarean delivery under spinal anesthesia will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

emre ulusoy, MD

CONTACT

[email protected]

05379492799

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Collaborators

  • Ulusoy, Emre, M.D.

Registry information

Official study title

Predictors of Severe Postoperative Pain Within the First 24 Hours After Elective Cesarean Delivery Under Spinal Anesthesia: A Prospective Observational Study

Acronym: CS-PAIN24

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 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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