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Clinical Trials/NCT06076018
NCT06076018
Completed
Not Applicable

The Contribution of Intrathecal Morphine Administration to Postoperative Patient Satisfaction During Cesarean Delivery

Ondokuz Mayıs University1 site in 1 country60 target enrollmentNovember 20, 2023

Overview

Phase
Not Applicable
Intervention
Group morphine
Conditions
Cesarean Section
Sponsor
Ondokuz Mayıs University
Enrollment
60
Locations
1
Primary Endpoint
Difference in QoR-40 score at 24th postoperative hour
Status
Completed
Last Updated
last year

Overview

Brief Summary

Evaluating the contribution of intrathecal morphine administration to postoperative patient satisfaction during cesarean delivery with the QoR-40 (Quality of Recovery 40) patient satisfaction compilation quality scale, scored between 40-200, and demonstrating the difference in the global QoR-40 score.

Detailed Description

All patients, whose consent was obtained, were monitored for standard noninvasive blood pressure, heart rate (HR), electrocardiogram (ECG) findings, and peripheral oxygen saturation (SpO2) in the operating room. Patients were evaluated for side effects such as pain, nausea-vomiting, itching, sedation score, and respiratory depression (defined as respiratory rate \<10/min or SpO2\<93%) for 24 hours postoperatively. Evaluations were made at the 2nd, 4th, 6th, 8th, 12th and 24th hours postoperatively. Pain assessment was made with the 'Numeric Rating Scale' (NRS) (0-10, 0 = no pain and 10 = worst pain imaginable), sedation assessment was made with the 'Ramsey Sedation Scale'. Nausea was evaluated as present or absent (0:absent, 1:present) and itching 'Verbal Descriptive Scale' (0: no itching, 1: was evaluated using mild, 2: moderate, 3: severe, 4: very severe). At the 24th postoperative hour, all patients were visited in the ward and the QoR-40 (Quality of Recovery-40) patient satisfaction compilation quality scale, scored between 40-200, was filled out. The QoR-40 questionnaire is a self-rating questionnaire used to evaluate the quality of postoperative recovery and health status of patients in the early postoperative stages. For the first time, Myles et al. () in 2000 and was proven to be a valid test in Turkey by Karaman S. et al. in 2014. QoR-40 was used to evaluate the pain levels, physical and emotional status of patients; emotional state (n = 9), comfort ( It consists of five sections and 40 questions: n = 12), patient support (n = 7), physical independence (n = 5), and pain (n = 7). Each question is scored on a five-point Likert scale ranging from 1 to 5. The total score ranges from 40 (worst build quality) to 200 (best build quality). This widely used survey has been successfully applied to populations with cultural and physical differences in many different countries. QoR-40 studies conducted after a wide variety of anesthesia and surgical techniques reveal how wide the field of use of the test is. As a result of all this, the researchers reported that the test was safe and applicable. Maternal characteristics such as age, weight, height, gestational age, gravidity, parity, number of previous cesarean births and procedure time, and tubal ligation were recorded. Newborn characteristics were collected, including weight and Apgar scores

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

Ilke Tamdogan

Principal Investigator

Ondokuz Mayıs University

Eligibility Criteria

Inclusion Criteria

  • Between 18-40 years old,
  • ASA physical status 2
  • Patients who will give birth by elective cesarean section

Exclusion Criteria

  • Those who do not accept regional anesthesia,
  • Pregnant women who have problems where spinal anesthesia is contraindicated, such as infection at the injection site, coagulopathy, bleeding diathesis, severe hypovolemia, increase in intracranial pressure, severe aortic stenosis, severe mitral stenosis,
  • Patients with a history of allergy to any drug included in the study protocol

Arms & Interventions

intrathecal morphine

In spinal anesthesia, 12 mg hyperbaric bupivacaine and 20 mcg fentanyl, 120 mcg intrathecal morphine (ITM) will be administered intrathecally.

Intervention: Group morphine

intrathecal fentanyl

Intrathecal 12 mg hyperbaric bupivacaine and 20 mcg fentanyl in spinal anesthesia, ITM will not be applied

Intervention: Group placebo

Outcomes

Primary Outcomes

Difference in QoR-40 score at 24th postoperative hour

Time Frame: Postoperative Day 1

Evaluation of the contribution of intrathecal morphine application to postoperative patient satisfaction during cesarean delivery with the QoR-40 (Quality of Recovery 40) patient satisfaction compilation quality scale scored between 40-200 and the difference in the global QoR-40 score

Secondary Outcomes

  • Post-operative acute pain(Postoperative Day 1)

Study Sites (1)

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