Health TrialsbyHealthPanel

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

ConditionsCesarean SectionPostoperative Pain After Cesarean SectionAcute Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorBursa City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women aged 18-45 years.

Elective cesarean delivery under spinal anesthesia.

Ability to understand Turkish.

Written informed consent.

Disqualifiers

Emergency cesarean delivery.

Conversion to general anesthesia.

Major obstetric hemorrhage.

Intensive care requirement.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational Assessment of Postoperative Pain

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Elective Cesarean Delivery Cohort1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bursa City Hospital

Lead sponsor

Ulusoy, Emre, M.D.

Collaborator

Source ClinicalTrials.gov
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