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Completed

NCT Number: NCT06076018

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University Faculty of Medicine

Samsun, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group morphine

Drug

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

Group placebo

Other

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

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Acronym: ITM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2023
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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