The Contribution of Intrathecal Morphine Administration to Postoperative Patient Satisfaction During Cesarean Delivery
- Conditions
- Intrathecal MorphineQuality of Recovery 40Cesarean Section
- Interventions
- Other: Group placebo
- Registration Number
- NCT06076018
- Lead Sponsor
- Ondokuz Mayıs University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- Between 18-40 years old,
- ASA physical status 2
- Patients who will give birth by elective cesarean section
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intrathecal morphine Group morphine In spinal anesthesia, 12 mg hyperbaric bupivacaine and 20 mcg fentanyl, 120 mcg intrathecal morphine (ITM) will be administered intrathecally. intrathecal fentanyl Group placebo Intrathecal 12 mg hyperbaric bupivacaine and 20 mcg fentanyl in spinal anesthesia, ITM will not be applied
- Primary Outcome Measures
Name Time Method Difference in QoR-40 score at 24th postoperative hour 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 Outcome Measures
Name Time Method Post-operative acute pain 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.
Trial Locations
- Locations (1)
Ondokuz Mayıs University Faculty of Medicine
🇹🇷Samsun, Turkey