Cesarean SectionCS-PAIN24NCT07789301
Predictors of Severe Postoperative Pain Within 24 Hours After Elective Cesarean Delivery Under Spinal Anesthesia
An observational study of Cesarean Section and Postoperative Pain After Cesarean Section, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section, Postoperative Pain After Cesarean Section, Acute Pain
- What is being tested?
- Observational Assessment of Postoperative Pain
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at Bursa City Hospital.
Who may be able to join
- Pregnant women aged 18-45 years.
- Elective cesarean delivery under spinal anesthesia.
- Ability to understand Turkish.
- Written informed consent.
Who cannot join
- Emergency cesarean delivery.
- Conversion to general anesthesia.
- Major obstetric hemorrhage.
- Intensive care requirement.
- Chronic opioid use.
- Severe psychiatric or neurological disease.
- Inability to communicate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, Nilüfer, 16110
emre ulusoy, 05379492799, emreulusoy36@gmail.com
About this study
Official title: Predictors of Severe Postoperative Pain Within the First 24 Hours After Elective Cesarean Delivery Under Spinal Anesthesia: A Prospective Observational Study
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.
- Being tested
- Observational Assessment of Postoperative Pain
- Keywords
- Cesarean Delivery, Spinal Anesthesia, Postoperative Pain, Severe Pain, Pain Predictors, Preoperative Anxiety
- Medical subject headings
- Acute Pain, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Assessment of Postoperative PainOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational Assessment of Postoperative Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after surgery
Secondary outcomes (7)
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.
Measured: Before surgery
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.
Measured: Before surgery
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.
Measured: Before surgery
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).
Measured: During surgery
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).
Measured: During surgery
Incidence of Intraoperative Hypotension
The occurrence of hypotension during cesarean delivery under spinal anesthesia will be recorded.
Measured: During surgery
Intraoperative Vasopressor Requirement
The requirement for vasopressor administration during cesarean delivery under spinal anesthesia will be recorded.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start15 Jul 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Collaborators
- Ulusoy, Emre, M.D.
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789301
- Sponsor's protocol ID
- BSHE5
- Acronym
- CS-PAIN24
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of participant confidentiality and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Severe Postoperative Pain Within the First 24 Hours After Elective Cesarean Delivery Under Spinal Anesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07789301
- Acronym / sponsor ID
- CS-PAIN24 / BSHE5
- Keywords
- Cesarean Delivery, Spinal Anesthesia, Postoperative Pain, Severe Pain, Pain Predictors, Preoperative Anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Collaborators
- Ulusoy, Emre, M.D.
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Cesarean Delivery Cohort | – | Other: Observational Assessment of Postoperative PainWomen 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at Bursa City Hospital.
Key inclusion criteria (4 listed)
- Pregnant women aged 18-45 years.
- Elective cesarean delivery under spinal anesthesia.
- Ability to understand Turkish.
- Written informed consent.
Key exclusion criteria (7 listed)
- Emergency cesarean delivery.
- Conversion to general anesthesia.
- Major obstetric hemorrhage.
- Intensive care requirement.
- Chronic opioid use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Assessment of Postoperative PainParticipants 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. | Other | Elective Cesarean Delivery Cohort |
Primary outcome
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.
7 secondary outcomes
Preoperative Anxiety Score
Time frame: Before surgery
Preoperative Information Requirement Score
Time frame: Before surgery
Expected Postoperative Pain
Time frame: Before surgery
Intraoperative Visceral Pain
Time frame: During surgery
Incidence of Intraoperative Shoulder Pain
Time frame: During surgery
Incidence of Intraoperative Hypotension
Time frame: During surgery
Intraoperative Vasopressor Requirement
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of participant confidentiality and institutional data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Postoperative Pain After Cesarean Section, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact emre ulusoy, MD (05379492799, emreulusoy36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Postoperative Pain (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.