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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07789301
Acronym
CS-PAIN24
Enrollment
200
Registered
2026-08-27
Start date
2026-07-15
Completion date
2026-10-15
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Cesarean Section, Postoperative Pain After Cesarean Section

Keywords

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

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.

Interventions

OTHERObservational Assessment of Postoperative Pain

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.

Sponsors

Bursa City Hospital
Lead SponsorOTHER_GOV
Ulusoy, Emre, M.D.
CollaboratorINDIV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Severe Postoperative PainWithin 24 hours after surgerySevere 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

MeasureTime frameDescription
Preoperative Anxiety ScoreBefore surgeryPreoperative 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.
Preoperative Information Requirement ScoreBefore surgeryInformation 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.
Expected Postoperative PainBefore surgeryExpected postoperative pain will be assessed using a Numerical Rating Scale ranging from 0 to 10, with higher scores indicating greater expected pain.
Intraoperative Visceral PainDuring surgeryThe proportion of patients who experience visceral pain during cesarean delivery under spinal anesthesia will be recorded as a binary outcome (Yes/No).
Incidence of Intraoperative Shoulder PainDuring surgeryThe proportion of patients who experience shoulder pain during cesarean delivery under spinal anesthesia will be recorded as a binary outcome (Yes/No).
Incidence of Intraoperative HypotensionDuring surgeryThe occurrence of hypotension during cesarean delivery under spinal anesthesia will be recorded.
Intraoperative Vasopressor RequirementDuring surgeryThe requirement for vasopressor administration during cesarean delivery under spinal anesthesia will be recorded.

Countries

Turkey (Türkiye)

Contacts

CONTACTemre ulusoy, MD
emreulusoy36@gmail.com05379492799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026