NCT06178458

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 11, 2023

Last Update Submit

December 20, 2023

Conditions

Keywords

cesarean deliveryopioid consumptionpain score

Outcome Measures

Primary Outcomes (1)

  • 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).

    January 2024 - December 2025

Secondary Outcomes (1)

  • Prediction of opioid consumption after cesarean delivery

    January 2024 - December 2025

Interventions

To collect data of pain score and opioid consumption of index and previous cesarean delivery

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale because only females can have cesarean delivery
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for cesarean delivery under spinal anesthesia with intrathecal morphine.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Boonsin Tangtrakulwanich, MD

    Prince of Songkla University

    STUDY CHAIR

Central Study Contacts

Sasikaan Nimmaanrat, MD, MMed

CONTACT

Boonsin Tangtrakulwanich, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 21, 2023

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

December 28, 2023

Record last verified: 2023-12