CClinicalTrials.gg
RecruitingNCT07789301CS-PAIN24Updated Aug 27, 2026

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

An observational study in Cesarean Section, Postoperative Pain After Cesarean Section and Acute Pain, sponsored by Bursa City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Bursa City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cesarean Section
  • Postoperative Pain After Cesarean Section
  • Acute Pain

Keywords

  • Cesarean Delivery
  • Spinal Anesthesia
  • Postoperative Pain
  • Severe Pain
  • Pain Predictors
  • Preoperative Anxiety
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

05

What researchers measure

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.

    Time frame: Within 24 hours after surgery

Secondary outcomes

  1. Preoperative Anxiety Score

    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.

    Time frame: Before surgery

  2. Preoperative Information Requirement Score

    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.

    Time frame: Before surgery

  3. Expected Postoperative Pain

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

    Time frame: Before surgery

  4. Intraoperative Visceral Pain

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

    Time frame: During surgery

  5. Incidence of Intraoperative Shoulder Pain

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

    Time frame: During surgery

  6. Incidence of Intraoperative Hypotension

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

    Time frame: During surgery

  7. Intraoperative Vasopressor Requirement

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

    Time frame: During surgery

06

Study locations

1 of 1 sites recruiting
  • Bursa City Hospital
    Bursa, Nilüfer 16110, Turkey (Türkiye)
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because of participant confidentiality and institutional data protection policies.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07789301
Lead sponsor
Bursa City Hospital
Collaborators
Ulusoy, Emre, M.D.
Responsible party
eralp çevikkalp (Associate Professor of Anesthesiology and Reanimation, M.D., Bursa City Hospital) — Principal investigator
First posted
Aug 27, 2026
Start date
Jul 15, 2026
Primary completion
Oct 15, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
Aug 27, 2026

Study contacts

emre ulusoy, MD
Contact
emreulusoy36@gmail.com
05379492799

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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