Pain Score and Opioid Consumption of Index and Previous Cesarean Delivery

December 20, 2023 updated by: Sasikaan Nimmaanrat, Prince of Songkla University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
January 2024 - December 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of opioid consumption after cesarean delivery
Time Frame: January 2024 - December 2025
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
January 2024 - December 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Investigators

  • Study Chair: Boonsin Tangtrakulwanich, MD, Prince of Songkla University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66-348-8-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD to be shared upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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