Relationship Between Analgesia Techniques and Post-cesarean Recovery Quality

January 23, 2023 updated by: Betul Kozanhan, Konya Meram State Hospital

Evaluation of the Relationship Between Different Postoperative Analgesia Techniques and Post-cesarean Quality of Recovery; Prospective Observational Study

The question remains whether the patients in whom USG-guided regional anesthesia and analgesia techniques are applied have a better recovery score than subarachnoid morphine administration, which is considered the gold standard. The primary aim of this study is to evaluate the quality of recovery score using the Obstetric Recovery Quality Score-ObsQoR-10 questionnaire experienced by the patients who underwent elective cesarean section and compare the results of different regional anesthesia techniques with subarachnoid morphine.

Study Overview

Status

Completed

Conditions

Detailed Description

National and international guidelines, hospital protocols, the anesthesiologist's experience, and the patient's decision play a role in selecting the technique used for postoperative analgesia after cesarean section. The quality of recovery score experienced following elective cesarean section in a total of 180 patients over one year (December 31, 2021-2022) who applied subarachnoid morphine, lateral TAP block, posterior-TAP block, QL block, ESP block, and TFD block (30 patients for each technique) will be evaluated with the ObsQoR-10 questionnaire 24 hours after delivery. The regional anesthesia techniques information applied to the patients will be obtained from the patient file. Researchers will not perform any interventional procedure, and any randomization will not be applied. After the data collection process for the study is completed, ObsQoR-10 will be compared statistically. The secondary aims of this study are to compare the cases in terms of postoperative analgesia and antiemetic requirements, first food intake and standing up without support, and patient satisfaction.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

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

Study Locations

  • Turkey
      • Konya, Turkey, 42005
        • Betul Kozanhan

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

18 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Term obstetric patients who underwent elective cesarean section under spinal anesthesia

Description

Inclusion Criteria:

  • Term obstetric patients aged 18-47 years who underwent elective cesarean section under spinal anesthesia and applied regional anesthesia techniques such as lateral TAP, posterior-TAP, QL, ESP, and TFD blocks or subarachnoid morphine.

Exclusion Criteria:

  • Patients with psychiatric disorders
  • Patients requiring emergency cesarean section.
  • Patients with additional obstetric pathology (such as placenta previa, preeclampsia, DM)
  • The need for intensive care in the mother or newborn at the end of the birth.
  • Patients who have undergone general anesthesia.
  • Preterm pregnants

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstetric Quality of Recovery
Time Frame: The first 24 hours postoperatively
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
The first 24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Konya Meram State Hospital

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 (Actual)

January 24, 2022

Primary Completion (Actual)

December 26, 2022

Study Completion (Actual)

December 26, 2022

Study Registration Dates

First Submitted

December 19, 2021

First Submitted That Met QC Criteria

December 19, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ObsQoR-10 PNB

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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