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

May 16, 2024 updated by: Ilke Tamdogan, Ondokuz Mayıs University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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
      • Samsun, Turkey
        • Ondokuz Mayıs University Faculty of Medicine

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

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intrathecal morphine
In spinal anesthesia, 12 mg hyperbaric bupivacaine and 20 mcg fentanyl, 120 mcg intrathecal morphine (ITM) will be administered intrathecally.
Drug: Group morphine
Spinal anesthesia will be applied to patients in a sitting position, with a midline approach, after aseptic conditions have been achieved. A 25 gauge pencil point spinal needle will be placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 12 mg hyperbaric bupivacaine and 20 mcg fentanyl will be administered intrathecally, and 120 mcg intrathecal morphine (ITM) will be administered to the morphine group. the 24th postoperative hour, all patients will be visited in the ward and the QoR-40 (Quality of Recovery-40) patient satisfaction recovery quality scale, scored between 40-200, will be filled out.
Other Names:
  • intrathecal morphine
Placebo Comparator: intrathecal fentanyl
Intrathecal 12 mg hyperbaric bupivacaine and 20 mcg fentanyl in spinal anesthesia, ITM will not be applied
Other: Group placebo
Spinal anesthesia will be applied to patients in a sitting position, with a midline approach, after aseptic conditions have been achieved. A 25 gauge pencil point spinal needle will be placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 12 mg hyperbaric bupivacaine and 20 mcg fentanyl will be administered intrathecally. the 24th postoperative hour, all patients will be visited in the ward and the QoR-40 (Quality of Recovery-40) patient satisfaction recovery quality scale, scored between 40-200, will be filled out.
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperative Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative acute pain
Time Frame: Postoperative Day 1
Pain status at rest and while activity (coughing and walking) was assessed by NRS scores at 2, 4, 6, 8, 12 and 24 hours after surgery. The NRS is an 11-point numeric scale which ranges from 0 to 10 at rest and during activity.
Postoperative Day 1

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 20, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • drilketamdogan

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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