PainNCT06178458
Pain Score and Opioid Consumption of Index and Previous Cesarean Delivery
An observational study of Pain and Postoperative, run by Prince of Songkla University.
Trial summary
Postoperative pain after cesarean delivery is common and affects on both mothers and children. The goals of this retrospective observational study aim to predict pain score and opioid consumption of index cesarean delivery from pain score and opioid consumption of previous cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- How many people
- 416 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for cesarean delivery under spinal anesthesia with intrathecal morphine.
Who may be able to join
- Patients who had at least 2 cesarean deliveries
- Patients received spinal anesthesia and intrathecal morphine for cesarean delivery
- Patients received postoperative pain control as per standard protocol
Who cannot join
- Patients with chronic pain prior to cesarean delivery
- Unable to give pain score
- Receiving general anesthesia for cesarean delivery
- Receiving postoperative pain control beyond the standard protocol
- Patients with multiple pregnancy, placenta abruption, placenta accrete, postpartum hemorrhage
- Patients with psychotic disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prediction of Pain Score and Opioid Consumption of Index Cesarean Delivery From Pain Score and Opioid Consumption of Previous Cesarean Delivery: A Retrospective Study
Postoperative pain after cesarean delivery is common and affects on both mothers and children.
The goals of this retrospective observational study aim to predict pain score and opioid consumption of index cesarean delivery from pain score and opioid consumption of previous cesarean delivery.
Read the detailed description
The authors will review the medical records of recruited participants for demographic data as well as pain scores and opioid consumption of index cesarean delivery and previous cesarean delivery.
- Conditions
- Pain, Postoperative
- Being tested
- No intervention
- Keywords
- cesarean delivery, opioid consumption, pain score
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
To collect data of pain score and opioid consumption of index and previous cesarean delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of pain score after cesarean delivery
To predict pain score of index cesarean delivery from previous cesarean delivery using pain score measured by verbal numerical rating scale (VNRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: January 2024 - December 2025
Secondary outcomes (1)
Prediction of opioid consumption after cesarean delivery
To predict opioid consumption of index cesarean delivery from previous cesarean delivery based on 1. number and percentage of patients who required opioid for controlling postoperative pain, 2. MME (milligram morphine equivalent) per total patients and 3. MME per patients who received opioid
Measured: January 2024 - December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Retrospective
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasikaan Nimmaanrat, Prince of Songkla University
- Investigators
- Boonsin Tangtrakulwanich, MD, Study chair, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178458
- Sponsor's protocol ID
- 66-348-8-1
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD to be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Pain Score and Opioid Consumption of Index Cesarean Delivery From Pain Score and Opioid Consumption of Previous Cesarean Delivery: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06178458
- Acronym / sponsor ID
- 66-348-8-1
- Conditions
- Pain, Postoperative
- Keywords
- cesarean delivery, opioid consumption, pain score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Dec 2023 (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.
Postoperative pain after cesarean delivery is common and affects on both mothers and children.
The goals of this retrospective observational study aim to predict pain score and opioid consumption of index cesarean delivery from pain score and opioid consumption of previous cesarean delivery.
Detailed description
The authors will review the medical records of recruited participants for demographic data as well as pain scores and opioid consumption of index cesarean delivery and previous cesarean delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cesarean delivery under spinal anesthesia with intrathecal morphine.
Key inclusion criteria (3 listed)
- Patients who had at least 2 cesarean deliveries
- Patients received spinal anesthesia and intrathecal morphine for cesarean delivery
- Patients received postoperative pain control as per standard protocol
Key exclusion criteria (6 listed)
- Patients with chronic pain prior to cesarean delivery
- Unable to give pain score
- Receiving general anesthesia for cesarean delivery
- Receiving postoperative pain control beyond the standard protocol
- Patients with multiple pregnancy, placenta abruption, placenta accrete, postpartum hemorrhage
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 |
|---|---|---|
| No interventionTo collect data of pain score and opioid consumption of index and previous cesarean delivery | Other | – |
Primary outcome
Prediction of pain score after cesarean delivery
Time frame: January 2024 - December 2025
To predict pain score of index cesarean delivery from previous cesarean delivery using pain score measured by verbal numerical rating scale (VNRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
1 secondary outcome
Prediction of opioid consumption after cesarean delivery
Time frame: January 2024 - December 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: Undecided. IPD to be shared upon request.
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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. This study is not recruiting at the moment.
Boonsin Tangtrakulwanich, MD study chair
Prince of Songkla University
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Postoperative, run by Prince of Songkla University.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sasikaan Nimmaanrat, MD, MMed (+66887907842, snimmaanrat@yahoo.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of pain score after cesarean delivery (time frame: January 2024 - December 2025). 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 28 Dec 2023.