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

NCT07789301 | Recruiting

• 1 other identifier: BSHE5
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section; Postoperative Pain After Cesarean Section; Acute Pain

Keywords

Cesarean Delivery; Spinal Anesthesia; Postoperative Pain; Severe Pain; Pain Predictors; Preoperative Anxiety

Outcome Measures

Primary Outcomes (1)

• Incidence of Severe Postoperative Pain

  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.

  Within 24 hours after surgery

Secondary Outcomes (7)

• Preoperative Anxiety Score

  Before surgery

• Preoperative Information Requirement Score

  Before surgery

• Expected Postoperative Pain

  Before surgery

• Intraoperative Visceral Pain

  During surgery

• Incidence of Intraoperative Shoulder Pain

  During surgery

Study Arms (1)

Elective Cesarean Delivery Cohort

Women undergoing elective cesarean delivery under spinal anesthesia. Preoperative, intraoperative, and postoperative variables will be recorded to identify predictors of severe pain during the first 24 postoperative hours. All participants will receive routine clinical care without additional interventions.

Other: Observational Assessment of Postoperative Pain

Interventions

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.

Elective Cesarean Delivery Cohort

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at Bursa City Hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bursa City Hospital: lead
• Ulusoy, Emre, M.D.: collaborator

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

emre ulusoy, MD

CONTACT

05379492799; emreulusoy36@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Reanimation, M.D.

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 27, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)